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Drybench Patent.

Patent and exclusivity dates from January to June 2032 for NDAs, as FDA's Orange Book lists them

Each patent and exclusivity date from January to June 2032 that FDA's Orange Book lists for an NDA, as captured on 14 October 2026. That capture lists a patent or exclusivity for 1,411 NDAs. Each entry is named by its rule and linked to its NDA page. A date here belongs to one patent or one exclusivity on the products named; the same NDA may have other listed dates, earlier or later, so no date here stands for a product.

FDA capture · review pending. Each date is shown as captured from FDA's Orange Book files. Dates are as FDA lists them, and Drybench computes none; patent dates are submitted by the applicant, and FDA does not verify them. Spreadsheet day numbers are shown as dates; a cell that cannot be read as one date is left off this page and shown as written on its NDA page. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.

Orange Book captured
14 October 2026

Listed protection is a range of the dates FDA lists, not a forecast of market entry, and not legal, regulatory or investment advice.

This page covers every NDA whose Orange Book capture lists a patent or exclusivity. It does not cover ANDAs or any BLA. NCE exclusivity dates are here as FDA lists them; NCE-1 dates, computed from them, are on the NCE-1 calendar.

Dates as listed in FDA's Orange Book capture of 14 October 2026. This page does not say whether a date has passed; compare it with today's date and FDA's current Orange Book. This page shows only what the capture of 14 October 2026 lists. It does not show patents or exclusivities listed before and since removed.

NCE-1, one year before a listed NCE exclusivity date and the one date Drybench computes, is on its own page: NCE-1 dates from the Orange Book

Listed dates, 2032July to December 2032

Listed patent expiry (292)

  • 1 Jan 2032 · NDA 207921 · BECLOMETHASONE DIPROPIONATE

    US 10,561,808, product patent

    patent.txt lines 7,443, 7,458
    Flags
    product delist requested
    Product numbers
    001, 002
  • 3 Jan 2032 · NDA 206323 · CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE

    US 9,066,942, use patent

    patent.txt line 6,474
    Flags
    use code U-1716
    Product numbers
    001
  • 3 Jan 2032 · NDA 206323 · CHLORPHENIRAMINE MALEATE; CODEINE PHOSPHATE

    US 9,107,921, product patent

    patent.txt line 6,475
    Flags
    product
    Product numbers
    001
  • 3 Jan 2032 · NDA 209521 · SARECYCLINE HYDROCHLORIDE

    US 8,318,706, substance and product and use patent

    patent.txt lines 10,589, 10,594, 10,599
    Flags
    substance product use code U-2405
    Product numbers
    001, 002, 003
  • 4 Jan 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE

    US 10,016,396, product patent

    patent.txt lines 407, 420
    Flags
    product
    Product numbers
    002, 003
  • 4 Jan 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE

    US 8,242,158, product patent

    patent.txt lines 409, 422, 434
    Flags
    product
    Product numbers
    002, 003, 004
  • 4 Jan 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE

    US 8,338,470, product patent

    patent.txt lines 411, 424, 436
    Flags
    product
    Product numbers
    002, 003, 004
  • 4 Jan 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE

    US 8,455,527, use patent

    patent.txt lines 413, 426, 438
    Flags
    use code U-421
    Product numbers
    002, 003, 004
  • 4 Jan 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE

    US 8,648,106, product patent

    patent.txt lines 415, 428, 440
    Flags
    product
    Product numbers
    002, 003, 004
  • 4 Jan 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE

    US 9,320,712, product patent

    patent.txt lines 417, 430, 442
    Flags
    product
    Product numbers
    002, 003, 004
  • 4 Jan 2032 · NDA 021038 · DEXMEDETOMIDINE HYDROCHLORIDE

    US 9,616,049, product patent

    patent.txt lines 419, 432, 444
    Flags
    product
    Product numbers
    002, 003, 004
  • 4 Jan 2032 · NDA 215596 · MARIBAVIR

    US 11,684,632, use patent

    patent.txt line 17,471
    Flags
    use code U-3650
    Product numbers
    001
  • 5 Jan 2032 · NDA 209884 · SIPONIMOD

    US 12,071,402, product patent

    patent.txt lines 10,986, 10,991, 10,996
    Flags
    product
    Product numbers
    001, 002, 003
  • 6 Jan 2032 · NDA 209819 · BUPRENORPHINE

    US 8,921,387, product and use patent

    patent.txt lines 10,843, 10,868
    Flags
    product use code U-2173
    Product numbers
    001, 002
  • 6 Jan 2032 · NDA 209819 · BUPRENORPHINE

    US 8,921,387, product and use patent

    patent.txt lines 10,844, 10,869
    Flags
    product use code U-2174
    Product numbers
    001, 002
  • 10 Jan 2032 · NDA 211155 · DUVELISIB

    US 11,312,718, product patent

    patent.txt lines 12,490, 12,498
    Flags
    product
    Product numbers
    001, 002
  • 10 Jan 2032 · NDA 211155 · DUVELISIB

    US 9,840,505, use patent

    patent.txt lines 12,495, 12,503
    Flags
    use code U-2412
    Product numbers
    001, 002
  • 10 Jan 2032 · NDA 211155 · DUVELISIB

    US 9,840,505, use patent

    patent.txt lines 12,496, 12,504
    Flags
    use code U-2413
    Product numbers
    001, 002
  • 11 Jan 2032 · NDA 212489 · OPICAPONE

    US 12,129,247, use patent

    patent.txt lines 14,087, 14,098
    Flags
    use code U-4038
    Product numbers
    001, 002
  • 13 Jan 2032 · NDA 200063 · BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE

    US 9,248,123, use patent

    patent.txt line 2,213
    Flags
    use code U-1808
    Product numbers
    001
  • 18 Jan 2032 · NDA 205755 · CERITINIB

    US 9,309,229, substance and product patent

    patent.txt line 5,858
    Flags
    substance product
    Product numbers
    001
  • 18 Jan 2032 · NDA 211225 · CERITINIB

    US 9,309,229, substance and product patent

    patent.txt line 12,554
    Flags
    substance product
    Product numbers
    001
  • 19 Jan 2032 · NDA 209394 · GLECAPREVIR; PIBRENTASVIR

    US 8,648,037, substance and product and use patent

    patent.txt line 10,311
    Flags
    substance product use code U-2141
    Product numbers
    001
  • 19 Jan 2032 · NDA 209394 · GLECAPREVIR; PIBRENTASVIR

    US 8,648,037, substance and product and use patent

    patent.txt line 10,312
    Flags
    substance product use code U-3237
    Product numbers
    001
  • 19 Jan 2032 · NDA 209394 · GLECAPREVIR; PIBRENTASVIR

    US 8,648,037, substance and product and use patent

    patent.txt line 10,313
    Flags
    substance product use code U-4206
    Product numbers
    001
  • 19 Jan 2032 · NDA 215110 · GLECAPREVIR; PIBRENTASVIR

    US 8,648,037, substance and product and use patent

    patent.txt line 16,486
    Flags
    substance product use code U-3238
    Product numbers
    001
  • 19 Jan 2032 · NDA 215110 · GLECAPREVIR; PIBRENTASVIR

    US 8,648,037, substance and product and use patent

    patent.txt line 16,487
    Flags
    substance product use code U-4206
    Product numbers
    001
  • 26 Jan 2032 · NDA 022569 · FENTANYL CITRATE

    US 9,731,869, product patent

    patent.txt lines 2,098–2,100
    Flags
    product
    Product numbers
    001, 002, 003
  • 27 Jan 2032 · NDA 217026 · TROFINETIDE

    US 9,212,204, use patent

    patent.txt line 19,256
    Flags
    use code U-3556
    Product numbers
    001
  • 27 Jan 2032 · NDA 219884 · TROFINETIDE

    US 9,212,204, use patent

    patent.txt lines 22,044, 22,052, 22,060
    Flags
    use code U-3556
    Product numbers
    001, 002, 003
  • 28 Jan 2032 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE

    US 8,580,304, product patent

    patent.txt lines 4,276, 4,296, 4,316
    Flags
    product
    Product numbers
    001, 002, 003
  • 28 Jan 2032 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE

    US 9,155,706, product patent

    patent.txt lines 4,286, 4,306, 4,326
    Flags
    product
    Product numbers
    001, 002, 003
  • 28 Jan 2032 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE

    US 9,271,941, product patent

    patent.txt lines 4,288, 4,308, 4,328
    Flags
    product
    Product numbers
    001, 002, 003
  • 28 Jan 2032 · NDA 204114 · TRAMETINIB DIMETHYL SULFOXIDE

    US 9,399,021, product patent

    patent.txt lines 4,290, 4,310, 4,330
    Flags
    product
    Product numbers
    001, 002, 003
  • 29 Jan 2032 · NDA 208573 · VENETOCLAX

    US 8,722,657, substance patent

    patent.txt lines 8,868, 8,882, 8,896
    Flags
    substance
    Product numbers
    001, 002, 003
  • 29 Jan 2032 · NDA 208945 · OZENOXACIN

    US 9,180,200, product and use patent

    patent.txt line 9,648
    Flags
    product use code U-805
    Product numbers
    001
  • 1 Feb 2032 · NDA 209637 · SEMAGLUTIDE

    US 9,132,239, product patent

    patent.txt lines 10,695, 10,713, 10,730, 10,748
    Flags
    product delist requested
    Product numbers
    001, 002, 003, 004
  • 2 Feb 2032 · NDA 205755 · CERITINIB

    US 8,703,787, use patent

    patent.txt line 5,857
    Flags
    use code U-1179
    Product numbers
    001
  • 2 Feb 2032 · NDA 211225 · CERITINIB

    US 8,703,787, use patent

    patent.txt line 12,553
    Flags
    use code U-1179
    Product numbers
    001
  • 3 Feb 2032 · NDA 217865 · GIVINOSTAT HYDROCHLORIDE

    US 9,421,184, use patent

    patent.txt line 20,750
    Flags
    use code U-3885
    Product numbers
    001
  • 3 Feb 2032 · NDA 217865 · GIVINOSTAT HYDROCHLORIDE

    US 9,867,799, use patent

    patent.txt line 20,751
    Flags
    use code U-3885
    Product numbers
    001
  • 4 Feb 2032 · NDA 205787 · NALOXONE HYDROCHLORIDE

    US 8,627,816, product patent

    patent.txt line 5,883
    Flags
    product
    Product numbers
    001
  • 4 Feb 2032 · NDA 209862 · NALOXONE HYDROCHLORIDE

    US 8,627,816, product patent

    patent.txt line 10,907
    Flags
    product
    Product numbers
    001
  • 8 Feb 2032 · NDA 209310 · MOMETASONE FUROATE

    US 8,763,222, product patent

    patent.txt line 10,076
    Flags
    product
    Product numbers
    001
  • 10 Feb 2032 · NDA 203756 · CABOZANTINIB S-MALATE

    US 11,298,349, product patent

    patent.txt lines 4,144, 4,152
    Flags
    product
    Product numbers
    001, 002
  • 10 Feb 2032 · NDA 203756 · CABOZANTINIB S-MALATE

    US 12,128,039, product and use patent

    patent.txt lines 4,145, 4,153
    Flags
    product use code U-1617
    Product numbers
    001, 002
  • 10 Feb 2032 · NDA 203756 · CABOZANTINIB S-MALATE

    US 9,717,720, product patent

    patent.txt lines 4,148, 4,156
    Flags
    product
    Product numbers
    001, 002
  • 10 Feb 2032 · NDA 207078 · SODIUM ZIRCONIUM CYCLOSILICATE

    US 10,335,432, use patent

    patent.txt line 7,010
    Flags
    use code U-2312
    Product numbers
    001
  • 10 Feb 2032 · NDA 207078 · SODIUM ZIRCONIUM CYCLOSILICATE

    US 10,398,730, use patent

    patent.txt lines 7,011, 7,024
    Flags
    use code U-2312
    Product numbers
    001, 002
  • 10 Feb 2032 · NDA 207078 · SODIUM ZIRCONIUM CYCLOSILICATE

    US 10,413,569, substance patent

    patent.txt lines 7,012, 7,025
    Flags
    substance
    Product numbers
    001, 002
  • 10 Feb 2032 · NDA 207078 · SODIUM ZIRCONIUM CYCLOSILICATE

    US 11,406,662, substance patent

    patent.txt lines 7,014, 7,027
    Flags
    substance
    Product numbers
    001, 002
  • 10 Feb 2032 · NDA 207078 · SODIUM ZIRCONIUM CYCLOSILICATE

    US 8,808,750, use patent

    patent.txt lines 7,017, 7,030
    Flags
    use code U-2312
    Product numbers
    001, 002
  • 10 Feb 2032 · NDA 207078 · SODIUM ZIRCONIUM CYCLOSILICATE

    US 9,844,567, use patent

    patent.txt lines 7,020, 7,033
    Flags
    use code U-2312
    Product numbers
    001, 002
  • 10 Feb 2032 · NDA 207078 · SODIUM ZIRCONIUM CYCLOSILICATE

    US 9,861,658, use patent

    patent.txt lines 7,021, 7,034
    Flags
    use code U-2312
    Product numbers
    001, 002
  • 10 Feb 2032 · NDA 208692 · CABOZANTINIB S-MALATE

    US 11,298,349, product patent

    patent.txt lines 9,187, 9,207, 9,227
    Flags
    product
    Product numbers
    001, 002, 003
  • 10 Feb 2032 · NDA 208692 · CABOZANTINIB S-MALATE

    US 12,128,039, product and use patent

    patent.txt lines 9,188, 9,208, 9,228
    Flags
    product use code U-1220
    Product numbers
    001, 002, 003
  • 10 Feb 2032 · NDA 208692 · CABOZANTINIB S-MALATE

    US 12,128,039, product and use patent

    patent.txt lines 9,189, 9,209, 9,229
    Flags
    product use code U-1480
    Product numbers
    001, 002, 003
  • 10 Feb 2032 · NDA 208692 · CABOZANTINIB S-MALATE

    US 12,128,039, product and use patent

    patent.txt lines 9,190, 9,210, 9,230
    Flags
    product use code U-2488
    Product numbers
    001, 002, 003
  • 10 Feb 2032 · NDA 208692 · CABOZANTINIB S-MALATE

    US 12,128,039, product and use patent

    patent.txt lines 9,191, 9,211, 9,231
    Flags
    product use code U-3225
    Product numbers
    001, 002, 003
  • 10 Feb 2032 · NDA 208692 · CABOZANTINIB S-MALATE

    US 12,128,039, product and use patent

    patent.txt lines 9,192, 9,212, 9,232
    Flags
    product use code U-4131
    Product numbers
    001, 002, 003
  • 10 Feb 2032 · NDA 208692 · CABOZANTINIB S-MALATE

    US 12,128,039, product and use patent

    patent.txt lines 9,193, 9,213, 9,233
    Flags
    product use code U-4156
    Product numbers
    001, 002, 003
  • 13 Feb 2032 · NDA 213378 · OLANZAPINE; SAMIDORPHAN L-MALATE

    US 8,778,960, use patent

    patent.txt lines 14,898, 14,919, 14,940, 14,961
    Flags
    use code U-3136
    Product numbers
    001, 002, 003, 004
  • 13 Feb 2032 · NDA 213378 · OLANZAPINE; SAMIDORPHAN L-MALATE

    US 8,778,960, use patent

    patent.txt lines 14,899, 14,920, 14,941, 14,962
    Flags
    use code U-3137
    Product numbers
    001, 002, 003, 004
  • 14 Feb 2032 · NDA 210951 · APALUTAMIDE

    US 8,445,507, substance and product and use patent

    patent.txt lines 12,440, 12,458
    Flags
    substance product use code U-2237
    Product numbers
    001, 002
  • 14 Feb 2032 · NDA 210951 · APALUTAMIDE

    US 8,445,507, substance and product and use patent

    patent.txt lines 12,441, 12,459
    Flags
    substance product use code U-2624
    Product numbers
    001, 002
  • 17 Feb 2032 · NDA 206333 · DEOXYCHOLIC ACID

    US 12,161,653, use patent

    patent.txt line 6,477
    Flags
    use code U-1940
    Product numbers
    001
  • 18 Feb 2032 · NDA 219208 · ATRASENTAN HYDROCHLORIDE

    US 11,874,283, use patent

    patent.txt line 21,549
    Flags
    use code U-3980
    Product numbers
    001
  • 19 Feb 2032 · NDA 217759 · LENIOLISIB PHOSPHATE

    US 8,653,092, substance and product patent

    patent.txt line 20,359
    Flags
    substance product
    Product numbers
    001
  • 29 Feb 2032 · NDA 207988 · LESINURAD

    US 8,546,436, substance and product patent

    patent.txt line 7,928
    Flags
    substance product
    Product numbers
    001
  • 29 Feb 2032 · NDA 209203 · ALLOPURINOL; LESINURAD

    US 8,546,436, substance patent

    patent.txt lines 9,863, 9,871
    Flags
    substance
    Product numbers
    001, 002
  • 1 Mar 2032 · NDA 021829 · ROTIGOTINE

    US 9,925,150, product patent

    patent.txt lines 712, 717, 722, 727, 732, 737
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005, 006
  • 1 Mar 2032 · NDA 208745 · PLECANATIDE

    US 11,319,346, product patent

    patent.txt line 9,305
    Flags
    product
    Product numbers
    001
  • 2 Mar 2032 · NDA 021903 · IBUPROFEN LYSINE

    US 8,415,337, substance and product patent

    patent.txt line 766
    Flags
    substance product
    Product numbers
    001
  • 2 Mar 2032 · NDA 217417 · REZAFUNGIN ACETATE

    US 11,654,196, substance and product and use patent

    patent.txt line 19,918
    Flags
    substance product use code U-3566
    Product numbers
    001
  • 4 Mar 2032 · NDA 021660 · PACLITAXEL

    US 9,393,318, use patent

    patent.txt line 668
    Flags
    use code U-1290
    Product numbers
    001
  • 4 Mar 2032 · NDA 021660 · PACLITAXEL

    US 9,597,409, use patent

    patent.txt line 672
    Flags
    use code U-1290
    Product numbers
    001
  • 4 Mar 2032 · NDA 208434 · ALECTINIB HYDROCHLORIDE

    US 9,365,514, product patent

    patent.txt line 8,619
    Flags
    product
    Product numbers
    001
  • 5 Mar 2032 · NDA 022287 · DEXLANSOPRAZOLE

    US 9,233,103, use patent

    patent.txt lines 1,563, 1,577
    Flags
    use code U-1805
    Product numbers
    001, 002
  • 7 Mar 2032 · NDA 208658 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

    US 10,596,120, product and use patent

    patent.txt lines 9,039, 9,071, 9,103, 9,133
    Flags
    product use code U-2775
    Product numbers
    001, 002, 003, 004
  • 7 Mar 2032 · NDA 208658 · EMPAGLIFLOZIN; METFORMIN HYDROCHLORIDE

    US 10,596,120, product and use patent

    patent.txt lines 9,040, 9,072, 9,104, 9,134
    Flags
    product use code U-2792
    Product numbers
    001, 002, 003, 004
  • 7 Mar 2032 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

    US 10,596,120, product and use patent

    patent.txt lines 14,229, 14,259, 14,289, 14,319
    Flags
    product use code U-2776
    Product numbers
    001, 002, 003, 004
  • 7 Mar 2032 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

    US 10,596,120, product and use patent

    patent.txt lines 14,230, 14,260, 14,290, 14,320
    Flags
    product use code U-2790
    Product numbers
    001, 002, 003, 004
  • 7 Mar 2032 · NDA 212614 · EMPAGLIFLOZIN; LINAGLIPTIN; METFORMIN HYDROCHLORIDE

    US 11,564,886, product and use patent

    patent.txt lines 14,233, 14,263, 14,293
    Flags
    product use code U-3531
    Product numbers
    001, 002, 003
  • 9 Mar 2032 · NDA 209381 · ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

    US 10,780,112, product patent

    patent.txt line 10,278
    Flags
    product
    Product numbers
    001
  • 9 Mar 2032 · NDA 209381 · ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

    US 10,792,306, product and use patent

    patent.txt line 10,279
    Flags
    product use code U-2310
    Product numbers
    001
  • 9 Mar 2032 · NDA 209381 · ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

    US 11,529,368, product and use patent

    patent.txt line 10,281
    Flags
    product use code U-2310
    Product numbers
    001
  • 10 Mar 2032 · NDA 212725 · ENTRECTINIB

    US 8,299,057, substance and product patent

    patent.txt lines 14,377, 14,396
    Flags
    substance product
    Product numbers
    001, 002
  • 11 Mar 2032 · NDA 208424 · NITROGLYCERIN

    US 9,101,592, product patent

    patent.txt line 8,615
    Flags
    product
    Product numbers
    001
  • 16 Mar 2032 · NDA 022348 · IBUPROFEN

    US 11,806,400, use patent

    patent.txt lines 1,725, 1,733
    Flags
    use code U-3746
    Product numbers
    002, 003
  • 16 Mar 2032 · NDA 022348 · IBUPROFEN

    US 9,072,661, use patent

    patent.txt line 1,737
    Flags
    use code U-2264
    Product numbers
    003
  • 16 Mar 2032 · NDA 022348 · IBUPROFEN

    US 9,072,710, use patent

    patent.txt line 1,738
    Flags
    use code U-2266
    Product numbers
    003
  • 19 Mar 2032 · NDA 207533 · ARIPIPRAZOLE LAUROXIL

    US 10,226,458, use patent

    patent.txt lines 7,275, 7,292, 7,310, 7,328
    Flags
    use code U-543
    Product numbers
    001, 002, 003, 004
  • 21 Mar 2032 · NDA 204447 · VORTIOXETINE HYDROBROMIDE

    US 9,278,096, use patent

    patent.txt lines 4,713, 4,733, 4,753, 4,773
    Flags
    use code U-2436
    Product numbers
    001, 002, 003, 004
  • 23 Mar 2032 · NDA 209311 · METHYLPHENIDATE HYDROCHLORIDE

    US 10,182,995, product patent

    patent.txt lines 10,078, 10,094, 10,110, 10,126, 10,142
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005
  • 23 Mar 2032 · NDA 209311 · METHYLPHENIDATE HYDROCHLORIDE

    US 10,292,937, use patent

    patent.txt lines 10,079, 10,095, 10,111, 10,127, 10,143
    Flags
    use code U-2357
    Product numbers
    001, 002, 003, 004, 005
  • 23 Mar 2032 · NDA 209311 · METHYLPHENIDATE HYDROCHLORIDE

    US 10,617,651, use patent

    patent.txt lines 10,080, 10,096, 10,112, 10,128, 10,144
    Flags
    use code U-2357
    Product numbers
    001, 002, 003, 004, 005
  • 23 Mar 2032 · NDA 209311 · METHYLPHENIDATE HYDROCHLORIDE

    US 10,881,618, use patent

    patent.txt lines 10,081, 10,097, 10,113, 10,129, 10,145
    Flags
    use code U-2357
    Product numbers
    001, 002, 003, 004, 005
  • 23 Mar 2032 · NDA 209311 · METHYLPHENIDATE HYDROCHLORIDE

    US 10,905,652, product patent

    patent.txt lines 10,082, 10,098, 10,114, 10,130, 10,146
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005
  • 23 Mar 2032 · NDA 209311 · METHYLPHENIDATE HYDROCHLORIDE

    US 11,241,391, use patent

    patent.txt lines 10,083, 10,099, 10,115, 10,131, 10,147
    Flags
    use code U-2357
    Product numbers
    001, 002, 003, 004, 005
  • 23 Mar 2032 · NDA 209311 · METHYLPHENIDATE HYDROCHLORIDE

    US 11,241,392, product patent

    patent.txt lines 10,084, 10,100, 10,116, 10,132, 10,148
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005
  • 23 Mar 2032 · NDA 209311 · METHYLPHENIDATE HYDROCHLORIDE

    US 11,911,518, use patent

    patent.txt lines 10,085, 10,101, 10,117, 10,133, 10,149
    Flags
    use code U-2357
    Product numbers
    001, 002, 003, 004, 005
  • 23 Mar 2032 · NDA 209311 · METHYLPHENIDATE HYDROCHLORIDE

    US 8,916,588, use patent

    patent.txt lines 10,086, 10,102, 10,118, 10,134, 10,150
    Flags
    use code U-2357
    Product numbers
    001, 002, 003, 004, 005
  • 23 Mar 2032 · NDA 209311 · METHYLPHENIDATE HYDROCHLORIDE

    US 8,927,010, product patent

    patent.txt lines 10,087, 10,103, 10,119, 10,135, 10,151
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005
  • 23 Mar 2032 · NDA 209311 · METHYLPHENIDATE HYDROCHLORIDE

    US 9,023,389, product patent

    patent.txt lines 10,088, 10,104, 10,120, 10,136, 10,152
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005
  • 23 Mar 2032 · NDA 209311 · METHYLPHENIDATE HYDROCHLORIDE

    US 9,028,868, use patent

    patent.txt lines 10,089, 10,105, 10,121, 10,137, 10,153
    Flags
    use code U-2357
    Product numbers
    001, 002, 003, 004, 005
  • 23 Mar 2032 · NDA 209311 · METHYLPHENIDATE HYDROCHLORIDE

    US 9,034,902, use patent

    patent.txt lines 10,090, 10,106, 10,122, 10,138, 10,154
    Flags
    use code U-2357
    Product numbers
    001, 002, 003, 004, 005
  • 23 Mar 2032 · NDA 209311 · METHYLPHENIDATE HYDROCHLORIDE

    US 9,283,214, product patent

    patent.txt lines 10,091, 10,107, 10,123, 10,139, 10,155
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005
  • 23 Mar 2032 · NDA 209311 · METHYLPHENIDATE HYDROCHLORIDE

    US 9,498,447, product patent

    patent.txt lines 10,092, 10,108, 10,124, 10,140, 10,156
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005
  • 23 Mar 2032 · NDA 209311 · METHYLPHENIDATE HYDROCHLORIDE

    US 9,603,809, use patent

    patent.txt lines 10,093, 10,109, 10,125, 10,141, 10,157
    Flags
    use code U-2357
    Product numbers
    001, 002, 003, 004, 005
  • 23 Mar 2032 · NDA 210730 · OLICERIDINE

    US 11,077,098, substance and product and use patent

    patent.txt lines 12,111, 12,116, 12,121
    Flags
    substance product use code U-2986
    Product numbers
    001, 002, 003
  • 23 Mar 2032 · NDA 210730 · OLICERIDINE

    US 11,931,350, substance and use patent

    patent.txt lines 12,112, 12,117, 12,122
    Flags
    substance use code U-2986
    Product numbers
    001, 002, 003
  • 23 Mar 2032 · NDA 210730 · OLICERIDINE

    US 8,835,488, substance and product and use patent

    patent.txt lines 12,113, 12,118, 12,123
    Flags
    substance product use code U-2986
    Product numbers
    001, 002, 003
  • 23 Mar 2032 · NDA 210730 · OLICERIDINE

    US 9,309,234, substance and product and use patent

    patent.txt lines 12,114, 12,119, 12,124
    Flags
    substance product use code U-2986
    Product numbers
    001, 002, 003
  • 23 Mar 2032 · NDA 210730 · OLICERIDINE

    US 9,642,842, product and use patent

    patent.txt lines 12,115, 12,120, 12,125
    Flags
    product use code U-2986
    Product numbers
    001, 002, 003
  • 23 Mar 2032 · NDA 217564 · FRUQUINTINIB

    US 7,829,574, substance and product patent

    patent.txt lines 20,002, 20,006
    Flags
    substance product
    Product numbers
    001, 002
  • 25 Mar 2032 · NDA 209381 · ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM SULFATE

    US 10,646,512, product patent

    patent.txt line 10,277
    Flags
    product
    Product numbers
    001
  • 29 Mar 2032 · NDA 209936 · COPANLISIB DIHYDROCHLORIDE

    US 10,383,876, substance and product patent

    patent.txt line 11,061
    Flags
    substance product
    Product numbers
    001
  • 29 Mar 2032 · NDA 209936 · COPANLISIB DIHYDROCHLORIDE

    US 9,636,344, use patent

    patent.txt line 11,062
    Flags
    use code U-2124
    Product numbers
    001
  • 30 Mar 2032 · NDA 022145 · RALTEGRAVIR POTASSIUM

    US 10,772,888, use patent

    patent.txt line 1,117
    Flags
    use code U-1663
    Product numbers
    002
  • 30 Mar 2032 · NDA 022527 · FINGOLIMOD HYDROCHLORIDE

    US 9,592,208, product and use patent

    patent.txt line 2,051
    Flags
    product use code U-2315
    Product numbers
    002
  • 31 Mar 2032 · NDA 021338 · FENTANYL HYDROCHLORIDE

    US 8,781,571, product and use patent

    patent.txt line 551
    Flags
    product use code U-736
    Product numbers
    001
  • 31 Mar 2032 · NDA 203491 · NEPAFENAC

    US 8,921,337, product patent

    patent.txt line 3,944
    Flags
    product
    Product numbers
    001
  • 2 Apr 2032 · NDA 204760 · NALOXEGOL OXALATE

    US 9,012,469, substance and product patent

    patent.txt lines 4,993, 4,995
    Flags
    substance product
    Product numbers
    001, 002
  • 6 Apr 2032 · NDA 021539 · ACETYLCYSTEINE

    US 8,722,738, use patent

    patent.txt line 629
    Flags
    use code U-1373
    Product numbers
    001
  • 7 Apr 2032 · NDA 022068 · NILOTINIB HYDROCHLORIDE

    US 9,061,029, substance and use patent

    patent.txt lines 1,006, 1,020, 1,034
    Flags
    substance use code U-1374
    Product numbers
    001, 002, 003
  • 7 Apr 2032 · NDA 022068 · NILOTINIB HYDROCHLORIDE

    US 9,061,029, substance and use patent

    patent.txt lines 1,007, 1,021, 1,035
    Flags
    substance use code U-3231
    Product numbers
    001, 002, 003
  • 7 Apr 2032 · NDA 212489 · OPICAPONE

    US 8,168,793, substance and product and use patent

    patent.txt lines 14,088, 14,099
    Flags
    substance product use code U-3869
    Product numbers
    001, 002
  • 10 Apr 2032 · NDA 212849 · RISPERIDONE

    US 10,098,882, product and use patent

    patent.txt lines 14,449, 14,454, 14,459, 14,464
    Flags
    product use code U-3513
    Product numbers
    001, 002, 003, 004
  • 10 Apr 2032 · NDA 212849 · RISPERIDONE

    US 10,406,161, product and use patent

    patent.txt lines 14,450, 14,455, 14,460, 14,465
    Flags
    product use code U-3513
    Product numbers
    001, 002, 003, 004
  • 10 Apr 2032 · NDA 212849 · RISPERIDONE

    US 11,110,094, product patent

    patent.txt lines 14,451, 14,456, 14,461, 14,466
    Flags
    product
    Product numbers
    001, 002, 003, 004
  • 10 Apr 2032 · NDA 212849 · RISPERIDONE

    US 9,446,135, product and use patent

    patent.txt lines 14,452, 14,457, 14,462, 14,467
    Flags
    product use code U-3513
    Product numbers
    001, 002, 003, 004
  • 10 Apr 2032 · NDA 212849 · RISPERIDONE

    US 9,532,991, product and use patent

    patent.txt lines 14,453, 14,458, 14,463, 14,468
    Flags
    product use code U-3513
    Product numbers
    001, 002, 003, 004
  • 13 Apr 2032 · NDA 206619 · DASABUVIR SODIUM; OMBITASVIR, PARITAPREVIR, RITONAVIR

    US 8,691,938, substance and product patent

    patent.txt line 6,610
    Flags
    substance product
    Product numbers
    001
  • 13 Apr 2032 · NDA 207931 · OMBITASVIR; PARITAPREVIR; RITONAVIR

    US 8,691,938, substance and product patent

    patent.txt line 7,652
    Flags
    substance product
    Product numbers
    001
  • 13 Apr 2032 · NDA 208624 · DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

    US 8,691,938, substance and product patent

    patent.txt line 9,006
    Flags
    substance product
    Product numbers
    001
  • 13 Apr 2032 · NDA 212888 · CABOTEGRAVIR; RILPIVIRINE

    US 11,389,448, product patent

    patent.txt lines 14,479, 14,489
    Flags
    product
    Product numbers
    001, 002
  • 15 Apr 2032 · NDA 219683 · GEMCITABINE HYDROCHLORIDE

    US 8,679,094, product patent

    patent.txt line 21,863
    Flags
    product
    Product numbers
    001
  • 16 Apr 2032 · NDA 050790 · CYCLOSPORINE

    US 8,561,859, product patent

    patent.txt line 2,141
    Flags
    product delist requested
    Product numbers
    002
  • 19 Apr 2032 · NDA 207078 · SODIUM ZIRCONIUM CYCLOSILICATE

    US 8,802,152, substance patent

    patent.txt lines 7,016, 7,029
    Flags
    substance
    Product numbers
    001, 002
  • 23 Apr 2032 · NDA 019034 · HYDROMORPHONE HYDROCHLORIDE

    US 9,731,082, product patent

    patent.txt lines 144, 146, 148, 150, 152, 154, 156
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005, 006, 007
  • 27 Apr 2032 · NDA 022201 · DEGARELIX ACETATE

    US 10,695,398, use patent

    patent.txt lines 1,314, 1,323
    Flags
    use code U-1895
    Product numbers
    001, 002
  • 27 Apr 2032 · NDA 022201 · DEGARELIX ACETATE

    US 11,766,468, use patent

    patent.txt lines 1,317, 1,326
    Flags
    use code U-1978
    Product numbers
    001, 002
  • 27 Apr 2032 · NDA 022201 · DEGARELIX ACETATE

    US 11,826,397, use patent

    patent.txt lines 1,318, 1,327
    Flags
    use code U-1978
    Product numbers
    001, 002
  • 27 Apr 2032 · NDA 022201 · DEGARELIX ACETATE

    US 9,415,085, use patent

    patent.txt lines 1,321, 1,330
    Flags
    use code U-1895
    Product numbers
    001, 002
  • 27 Apr 2032 · NDA 218614 · OLEZARSEN SODIUM

    US 9,157,082, use patent

    patent.txt line 21,140
    Flags
    use code U-4050
    Product numbers
    001
  • 27 Apr 2032 · NDA 218614 · OLEZARSEN SODIUM

    US 9,157,082, use patent

    patent.txt lines 21,141, 21,147
    Flags
    use code U-4580
    Product numbers
    001, 002
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 249
    Flags
    use code U-2870
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 250
    Flags
    use code U-2871
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 251
    Flags
    use code U-2872
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 252
    Flags
    use code U-2873
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 253
    Flags
    use code U-2874
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 254
    Flags
    use code U-2875
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 255
    Flags
    use code U-2876
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 256
    Flags
    use code U-2877
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 257
    Flags
    use code U-2878
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 258
    Flags
    use code U-2879
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 259
    Flags
    use code U-2880
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 260
    Flags
    use code U-2881
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 261
    Flags
    use code U-2882
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 262
    Flags
    use code U-2883
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 263
    Flags
    use code U-2884
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 264
    Flags
    use code U-2885
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 265
    Flags
    use code U-2886
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 266
    Flags
    use code U-2887
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 10,688,094, use patent

    patent.txt line 267
    Flags
    use code U-2888
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 11,000,522, use patent

    patent.txt line 317
    Flags
    use code U-3119
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 11,000,522, use patent

    patent.txt line 318
    Flags
    use code U-3120
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 11,000,522, use patent

    patent.txt line 319
    Flags
    use code U-3121
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 11,000,522, use patent

    patent.txt line 320
    Flags
    use code U-3122
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 11,666,567, use patent

    patent.txt line 321
    Flags
    use code U-4015
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 11,666,567, use patent

    patent.txt line 322
    Flags
    use code U-4016
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 11,666,567, use patent

    patent.txt line 323
    Flags
    use code U-4017
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 11,666,567, use patent

    patent.txt line 324
    Flags
    use code U-4018
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 8,431,155, product and use patent

    patent.txt line 325
    Flags
    product use code U-976
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 8,613,947, product and use patent

    patent.txt line 326
    Flags
    product use code U-976
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,192,576, product and use patent

    patent.txt line 328
    Flags
    product use code U-976
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,522,117, product and use patent

    patent.txt line 338
    Flags
    product use code U-1939
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,522,117, product and use patent

    patent.txt line 339
    Flags
    product use code U-976
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,700,555, product and use patent

    patent.txt line 340
    Flags
    product use code U-2183
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,700,555, product and use patent

    patent.txt line 341
    Flags
    product use code U-2184
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,700,555, product and use patent

    patent.txt line 342
    Flags
    product use code U-2185
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,700,555, product and use patent

    patent.txt line 343
    Flags
    product use code U-2186
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,700,555, product and use patent

    patent.txt line 344
    Flags
    product use code U-2187
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,700,555, product and use patent

    patent.txt line 345
    Flags
    product use code U-2188
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,700,555, product and use patent

    patent.txt line 346
    Flags
    product use code U-2189
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,700,555, product and use patent

    patent.txt line 347
    Flags
    product use code U-2190
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,700,555, product and use patent

    patent.txt line 348
    Flags
    product use code U-2191
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,700,555, product and use patent

    patent.txt line 349
    Flags
    product use code U-2192
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,700,555, product and use patent

    patent.txt line 350
    Flags
    product use code U-2193
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,700,555, product and use patent

    patent.txt line 351
    Flags
    product use code U-2194
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,700,555, product and use patent

    patent.txt line 352
    Flags
    product use code U-2195
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,700,555, product and use patent

    patent.txt line 353
    Flags
    product use code U-2196
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,700,555, product and use patent

    patent.txt line 354
    Flags
    product use code U-2197
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,700,555, product and use patent

    patent.txt line 355
    Flags
    product use code U-2198
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,993,474, use patent

    patent.txt line 365
    Flags
    use code U-2384
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,993,474, use patent

    patent.txt line 366
    Flags
    use code U-2385
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,993,474, use patent

    patent.txt line 367
    Flags
    use code U-2386
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,993,474, use patent

    patent.txt line 368
    Flags
    use code U-2387
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,993,474, use patent

    patent.txt line 369
    Flags
    use code U-2388
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,993,474, use patent

    patent.txt line 370
    Flags
    use code U-2389
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,993,474, use patent

    patent.txt line 371
    Flags
    use code U-2390
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,993,474, use patent

    patent.txt line 372
    Flags
    use code U-2391
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,993,474, use patent

    patent.txt line 373
    Flags
    use code U-2392
    Product numbers
    001
  • 30 Apr 2032 · NDA 020866 · BROMOCRIPTINE MESYLATE

    US 9,993,474, use patent

    patent.txt line 374
    Flags
    use code U-2393
    Product numbers
    001
  • 30 Apr 2032 · NDA 219876 · DORDAVIPRONE HYDROCHLORIDE

    US 9,629,842, use patent

    patent.txt line 22,033
    Flags
    use code U-4254
    Product numbers
    001
  • 1 May 2032 · NDA 208611 · DELAFLOXACIN MEGLUMINE

    US 12,138,257, product patent

    patent.txt line 8,914
    Flags
    product
    Product numbers
    001
  • 3 May 2032 · NDA 216196 · MITAPIVAT SULFATE

    US 10,632,114, use patent

    patent.txt lines 18,432, 18,441, 18,450
    Flags
    use code U-3320
    Product numbers
    001, 002, 003
  • 3 May 2032 · NDA 216196 · MITAPIVAT SULFATE

    US 10,632,114, use patent

    patent.txt line 18,459
    Flags
    use code U-4391
    Product numbers
    004
  • 3 May 2032 · NDA 216196 · MITAPIVAT SULFATE

    US 9,682,080, use patent

    patent.txt lines 18,438, 18,447, 18,456
    Flags
    use code U-3319
    Product numbers
    001, 002, 003
  • 3 May 2032 · NDA 216196 · MITAPIVAT SULFATE

    US 9,682,080, use patent

    patent.txt line 18,463
    Flags
    use code U-4392
    Product numbers
    004
  • 3 May 2032 · NDA 216196 · MITAPIVAT SULFATE

    US 9,980,961, use patent

    patent.txt lines 18,439, 18,448, 18,457
    Flags
    use code U-3319
    Product numbers
    001, 002, 003
  • 6 May 2032 · NDA 213498 · PONESIMOD

    US 9,062,014, substance and product and use patent

    patent.txt lines 15,072, 15,078
    Flags
    substance product use code U-2774
    Product numbers
    001, 010
  • 8 May 2032 · NDA 207916 · ACETYLCYSTEINE

    US 8,747,894, product and use patent

    patent.txt lines 7,434, 7,437
    Flags
    product use code U-1373
    Product numbers
    001, 002
  • 8 May 2032 · NDA 207916 · ACETYLCYSTEINE

    US 9,427,421, product patent

    patent.txt lines 7,435, 7,438
    Flags
    product
    Product numbers
    001, 002
  • 8 May 2032 · NDA 207916 · ACETYLCYSTEINE

    US 9,561,204, use patent

    patent.txt lines 7,436, 7,439
    Flags
    use code U-1373
    Product numbers
    001, 002
  • 10 May 2032 · NDA 022088 · TEMSIROLIMUS

    US 8,791,097, use patent

    patent.txt line 1,049
    Flags
    use code U-1550
    Product numbers
    001
  • 10 May 2032 · NDA 022088 · TEMSIROLIMUS

    US 8,791,097, use patent

    patent.txt line 1,050
    Flags
    use code U-1551
    Product numbers
    001
  • 11 May 2032 · NDA 208912 · DEXAMETHASONE

    US 10,799,642, product patent

    patent.txt line 9,612
    Flags
    product
    Product numbers
    001
  • 11 May 2032 · NDA 217722 · NALOXONE HYDROCHLORIDE

    US 11,020,343, use patent

    patent.txt line 20,336
    Flags
    use code U-3671
    Product numbers
    001
  • 11 May 2032 · NDA 217722 · NALOXONE HYDROCHLORIDE

    US 11,806,428, product patent

    patent.txt line 20,337
    Flags
    product
    Product numbers
    001
  • 11 May 2032 · NDA 217722 · NALOXONE HYDROCHLORIDE

    US 12,458,591, use patent

    patent.txt line 20,338
    Flags
    use code U-3671
    Product numbers
    001
  • 12 May 2032 · NDA 205098 · POLIDOCANOL

    US 9,480,652, product patent

    patent.txt line 5,202
    Flags
    product
    Product numbers
    001
  • 14 May 2032 · NDA 214373 · BEXAGLIFLOZIN

    US 8,987,323, substance and product patent

    patent.txt line 15,733
    Flags
    substance product
    Product numbers
    001
  • 16 May 2032 · NDA 204031 · ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

    US 8,658,631, product patent

    patent.txt line 4,225
    Flags
    product
    Product numbers
    001
  • 16 May 2032 · NDA 204031 · ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

    US 8,741,885, product and use patent

    patent.txt line 4,227
    Flags
    product use code U-1499
    Product numbers
    001
  • 16 May 2032 · NDA 204031 · ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

    US 8,992,975, product patent

    patent.txt line 4,229
    Flags
    product
    Product numbers
    001
  • 16 May 2032 · NDA 204031 · ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

    US 9,050,335, product patent

    patent.txt line 4,230
    Flags
    product
    Product numbers
    001
  • 16 May 2032 · NDA 204031 · ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE

    US 9,468,636, use patent

    patent.txt line 4,231
    Flags
    use code U-1499
    Product numbers
    001
  • 17 May 2032 · NDA 208624 · DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

    US 10,201,541, product patent

    patent.txt line 8,995
    Flags
    product
    Product numbers
    001
  • 17 May 2032 · NDA 208624 · DASABUVIR SODIUM; OMBITASVIR; PARITAPREVIR; RITONAVIR

    US 10,201,584, use patent

    patent.txt line 8,996
    Flags
    use code U-1889
    Product numbers
    001
  • 17 May 2032 · NDA 211155 · DUVELISIB

    US RE46621, substance and product patent

    patent.txt lines 12,497, 12,505
    Flags
    substance product
    Product numbers
    001, 002
  • 17 May 2032 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

    US 10,047,053, substance patent

    patent.txt lines 21,185, 21,228
    Flags
    substance
    Product numbers
    001, 002
  • 17 May 2032 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

    US 8,865,902, substance and product patent

    patent.txt lines 21,215, 21,265
    Flags
    substance product
    Product numbers
    001, 002
  • 17 May 2032 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

    US 9,181,192, substance and product and use patent

    patent.txt lines 21,216, 21,267
    Flags
    substance product use code U-4094
    Product numbers
    001, 002
  • 17 May 2032 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

    US 9,181,192, substance and product and use patent

    patent.txt lines 21,217, 21,268
    Flags
    substance product use code U-4472
    Product numbers
    001, 002
  • 17 May 2032 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

    US 9,512,079, substance and product and use patent

    patent.txt lines 21,218, 21,269
    Flags
    substance product use code U-4098
    Product numbers
    001, 002
  • 17 May 2032 · NDA 218730 · DEUTIVACAFTOR; TEZACAFTOR; VANZACAFTOR CALCIUM

    US 9,512,079, substance and product and use patent

    patent.txt lines 21,219, 21,270
    Flags
    substance product use code U-4471
    Product numbers
    001, 002
  • 18 May 2032 · NDA 209394 · GLECAPREVIR; PIBRENTASVIR

    US 8,937,150, substance and product patent

    patent.txt line 10,315
    Flags
    substance product
    Product numbers
    001
  • 18 May 2032 · NDA 215110 · GLECAPREVIR; PIBRENTASVIR

    US 8,937,150, substance and product patent

    patent.txt line 16,489
    Flags
    substance product
    Product numbers
    001
  • 19 May 2032 · NDA 206276 · OLOPATADINE HYDROCHLORIDE

    US 8,791,154, product and use patent

    patent.txt line 6,455
    Flags
    product use code U-1680
    Product numbers
    001
  • 19 May 2032 · NDA 206276 · OLOPATADINE HYDROCHLORIDE

    US 9,533,053, product patent

    patent.txt line 6,456
    Flags
    product
    Product numbers
    001
  • 21 May 2032 · NDA 021338 · FENTANYL HYDROCHLORIDE

    US 8,428,708, use patent

    patent.txt line 549
    Flags
    use code U-736
    Product numbers
    001
  • 23 May 2032 · NDA 204168 · LEVOMILNACIPRAN HYDROCHLORIDE

    US 8,865,937, substance and product patent

    patent.txt lines 4,338, 4,341, 4,344, 4,347
    Flags
    substance product
    Product numbers
    001, 002, 003, 004
  • 23 May 2032 · NDA 208573 · VENETOCLAX

    US 11,369,599, product patent

    patent.txt lines 8,864, 8,878, 8,892
    Flags
    product
    Product numbers
    001, 002, 003
  • 23 May 2032 · NDA 210493 · FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

    US 10,208,073, use patent

    patent.txt lines 11,479, 11,491
    Flags
    use code U-2301
    Product numbers
    001, 002
  • 23 May 2032 · NDA 210493 · FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

    US 10,717,721, substance patent

    patent.txt lines 11,481, 11,493
    Flags
    substance
    Product numbers
    001, 002
  • 23 May 2032 · NDA 210493 · FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

    US 11,312,698, substance and product patent

    patent.txt lines 11,483, 11,495
    Flags
    substance product
    Product numbers
    001, 002
  • 23 May 2032 · NDA 210493 · FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

    US 8,426,450, substance and product patent

    patent.txt lines 11,486, 11,498
    Flags
    substance product
    Product numbers
    001, 002
  • 23 May 2032 · NDA 210493 · FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

    US 8,895,586, use patent

    patent.txt lines 11,487, 11,499
    Flags
    use code U-2301
    Product numbers
    001, 002
  • 23 May 2032 · NDA 210493 · FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

    US 9,403,772, substance and use patent

    patent.txt lines 11,489, 11,501
    Flags
    substance use code U-2301
    Product numbers
    001, 002
  • 23 May 2032 · NDA 210493 · FOSNETUPITANT CHLORIDE HYDROCHLORIDE; PALONOSETRON HYDROCHLORIDE

    US 9,908,907, substance and product patent

    patent.txt lines 11,490, 11,502
    Flags
    substance product
    Product numbers
    001, 002
  • 25 May 2032 · NDA 216986 · GADOPICLENOL

    US 8,114,863, substance and product patent

    patent.txt lines 19,100, 19,104, 19,108, 19,112, 19,116, 19,120, 19,124
    Flags
    substance product
    Product numbers
    001, 002, 003, 004, 005, 006, 007
  • 26 May 2032 · NDA 212123 · FLORTAUCIPIR F-18

    US 8,932,557, substance patent

    patent.txt lines 13,599–13,602
    Flags
    substance
    Product numbers
    001, 002, 003, 004
  • 31 May 2032 · NDA 207924 · BARICITINIB

    US 8,158,616, substance and product patent

    patent.txt lines 7,476, 7,482, 7,488
    Flags
    substance product
    Product numbers
    001, 002, 003
  • 4 Jun 2032 · NDA 212327 · FEDRATINIB HYDROCHLORIDE

    US 10,391,094, product and use patent

    patent.txt line 13,949
    Flags
    product use code U-2607
    Product numbers
    001
  • 5 Jun 2032 · NDA 205494 · ELIGLUSTAT TARTRATE

    US 12,465,586, use patent

    patent.txt line 5,456
    Flags
    use code U-3042
    Product numbers
    001
  • 5 Jun 2032 · NDA 205494 · ELIGLUSTAT TARTRATE

    US 12,465,586, use patent

    patent.txt line 5,457
    Flags
    use code U-3043
    Product numbers
    001
  • 6 Jun 2032 · NDA 202429 · VEMURAFENIB

    US 9,447,089, product patent

    patent.txt line 3,093
    Flags
    product
    Product numbers
    001
  • 7 Jun 2032 · NDA 213973 · RIPRETINIB

    US RE48731, use patent

    patent.txt line 15,393
    Flags
    use code U-3219
    Product numbers
    001
  • 11 Jun 2032 · NDA 021338 · FENTANYL HYDROCHLORIDE

    US 8,428,709, product and use patent

    patent.txt line 550
    Flags
    product use code U-736
    Product numbers
    001
  • 13 Jun 2032 · NDA 207202 · ARIPIPRAZOLE

    US 10,517,507, product patent

    patent.txt lines 7,063, 7,090, 7,117, 7,144, 7,171, 7,198
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005, 006
  • 13 Jun 2032 · NDA 211635 · DIAZEPAM

    US 12,337,061, use patent

    patent.txt lines 12,912, 12,920, 12,928
    Flags
    use code U-4173
    Product numbers
    001, 002, 003
  • 15 Jun 2032 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME

    US 8,969,566, substance patent

    patent.txt line 6,580
    Flags
    substance
    Product numbers
    001
  • 15 Jun 2032 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME

    US 9,284,314, substance patent

    patent.txt line 6,581
    Flags
    substance
    Product numbers
    001
  • 15 Jun 2032 · NDA 206494 · AVIBACTAM SODIUM; CEFTAZIDIME

    US 9,695,122, substance patent

    patent.txt line 6,582
    Flags
    substance
    Product numbers
    001
  • 15 Jun 2032 · NDA 217906 · AVIBACTAM SODIUM; AZTREONAM

    US 8,969,566, substance patent

    patent.txt line 20,775
    Flags
    substance
    Product numbers
    001
  • 15 Jun 2032 · NDA 217906 · AVIBACTAM SODIUM; AZTREONAM

    US 9,284,314, substance patent

    patent.txt line 20,776
    Flags
    substance
    Product numbers
    001
  • 15 Jun 2032 · NDA 217906 · AVIBACTAM SODIUM; AZTREONAM

    US 9,695,122, substance and product patent

    patent.txt line 20,777
    Flags
    substance product
    Product numbers
    001
  • 22 Jun 2032 · NDA 208114 · DEFIBROTIDE SODIUM

    US 11,085,043, product patent

    patent.txt line 8,263
    Flags
    product
    Product numbers
    001
  • 22 Jun 2032 · NDA 208114 · DEFIBROTIDE SODIUM

    US 11,236,328, use patent

    patent.txt line 8,264
    Flags
    use code U-3301
    Product numbers
    001
  • 22 Jun 2032 · NDA 208114 · DEFIBROTIDE SODIUM

    US 11,746,348, product patent

    patent.txt line 8,265
    Flags
    product
    Product numbers
    001
  • 22 Jun 2032 · NDA 208114 · DEFIBROTIDE SODIUM

    US 12,529,052, product patent

    patent.txt line 8,266
    Flags
    product
    Product numbers
    001
  • 22 Jun 2032 · NDA 208114 · DEFIBROTIDE SODIUM

    US 12,534,722, product patent

    patent.txt line 8,267
    Flags
    product
    Product numbers
    001
  • 25 Jun 2032 · NDA 210303 · PLAZOMICIN SULFATE

    US 8,383,596, substance and use patent

    patent.txt line 11,300
    Flags
    substance use code U-2328
    Product numbers
    001
  • 28 Jun 2032 · NDA 204325 · AMPHETAMINE

    US 8,709,491, product patent

    patent.txt line 4,473
    Flags
    product
    Product numbers
    001
  • 28 Jun 2032 · NDA 204325 · AMPHETAMINE

    US 9,017,731, product patent

    patent.txt line 4,474
    Flags
    product
    Product numbers
    001
  • 28 Jun 2032 · NDA 204325 · AMPHETAMINE

    US 9,265,737, product patent

    patent.txt line 4,475
    Flags
    product
    Product numbers
    001
  • 28 Jun 2032 · NDA 204326 · AMPHETAMINE

    US 8,709,491, product patent

    patent.txt lines 4,476, 4,481, 4,486, 4,491, 4,496, 4,501
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005, 006
  • 28 Jun 2032 · NDA 204326 · AMPHETAMINE

    US 9,017,731, product patent

    patent.txt lines 4,478, 4,483, 4,488, 4,493, 4,498, 4,503
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005, 006
  • 28 Jun 2032 · NDA 204326 · AMPHETAMINE

    US 9,265,737, product patent

    patent.txt lines 4,479, 4,484, 4,489, 4,494, 4,499, 4,504
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005, 006
  • 28 Jun 2032 · NDA 204326 · AMPHETAMINE

    US 9,839,619, product patent

    patent.txt lines 4,480, 4,485, 4,490, 4,495, 4,500, 4,505
    Flags
    product
    Product numbers
    001, 002, 003, 004, 005, 006
  • 28 Jun 2032 · NDA 205223 · METRONIDAZOLE

    US 10,238,634, product patent

    patent.txt line 5,271
    Flags
    product
    Product numbers
    001
  • 28 Jun 2032 · NDA 205223 · METRONIDAZOLE

    US 10,596,155, product patent

    patent.txt line 5,272
    Flags
    product
    Product numbers
    001
  • 28 Jun 2032 · NDA 205223 · METRONIDAZOLE

    US 8,946,276, use patent

    patent.txt line 5,276
    Flags
    use code U-1664
    Product numbers
    001
  • 28 Jun 2032 · NDA 205223 · METRONIDAZOLE

    US 9,198,858, use patent

    patent.txt line 5,277
    Flags
    use code U-1664
    Product numbers
    001
  • 28 Jun 2032 · NDA 205489 · METHYLPHENIDATE

    US 9,072,680, product patent

    patent.txt lines 5,441, 5,445, 5,449
    Flags
    product
    Product numbers
    001, 002, 003
  • 28 Jun 2032 · NDA 205489 · METHYLPHENIDATE

    US 9,089,496, product patent

    patent.txt lines 5,442, 5,446, 5,450
    Flags
    product
    Product numbers
    001, 002, 003
  • 29 Jun 2032 · NDA 208078 · AMIFAMPRIDINE PHOSPHATE

    US 11,060,128, use patent

    patent.txt line 8,096
    Flags
    use code U-2956
    Product numbers
    001
  • 29 Jun 2032 · NDA 208078 · AMIFAMPRIDINE PHOSPHATE

    US 11,268,128, use patent

    patent.txt line 8,097
    Flags
    use code U-2956
    Product numbers
    001
  • 29 Jun 2032 · NDA 208078 · AMIFAMPRIDINE PHOSPHATE

    US 11,274,331, use patent

    patent.txt line 8,098
    Flags
    use code U-2956
    Product numbers
    001
  • 29 Jun 2032 · NDA 208078 · AMIFAMPRIDINE PHOSPHATE

    US 11,274,332, use patent

    patent.txt line 8,099
    Flags
    use code U-2956
    Product numbers
    001
  • 29 Jun 2032 · NDA 214902 · BENZOYL PEROXIDE; TRETINOIN

    US 12,053,546, product patent

    patent.txt line 16,309
    Flags
    product
    Product numbers
    001

Pediatric exclusivity, as listed (10)

  • 11 Feb 2032 · NDA 202811 · LINACLOTIDE

    US 10,675,325 with pediatric exclusivity, as listed

    patent.txt line 3,359
    Flags
    product pediatric, as listed by FDA (from the base row)
    Product numbers
    003
  • 11 Feb 2032 · NDA 202811 · LINACLOTIDE

    US 10,702,576 with pediatric exclusivity, as listed

    patent.txt line 3,361
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    003
  • 11 Mar 2032 · NDA 022450 · ACETAMINOPHEN

    US 9,399,012 with pediatric exclusivity, as listed

    patent.txt line 1,913
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • 30 Apr 2032 · NDA 202811 · LINACLOTIDE

    US 8,748,573 with pediatric exclusivity, as listed

    patent.txt lines 3,335, 3,350
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002
  • 30 Apr 2032 · NDA 202811 · LINACLOTIDE

    US 8,802,628 with pediatric exclusivity, as listed

    patent.txt lines 3,339, 3,353
    Flags
    product pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002
  • 9 May 2032 · NDA 209092 · RIBOCICLIB SUCCINATE

    US 9,193,732 with pediatric exclusivity, as listed

    patent.txt line 9,710
    Flags
    substance product pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • 9 May 2032 · NDA 209092 · RIBOCICLIB SUCCINATE

    US 9,868,739 with pediatric exclusivity, as listed

    patent.txt line 9,720
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • 9 May 2032 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE

    US 9,193,732 with pediatric exclusivity, as listed

    patent.txt line 11,051
    Flags
    substance product pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • 9 May 2032 · NDA 209935 · LETROZOLE; RIBOCICLIB SUCCINATE

    US 9,868,739 with pediatric exclusivity, as listed

    patent.txt line 11,057
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001
  • 8 Jun 2032 · NDA 214787 · REMDESIVIR

    US 11,492,353 with pediatric exclusivity, as listed

    patent.txt lines 16,140, 16,174
    Flags
    substance pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002

Non-patent exclusivity (25)

  • 16 Jan 2032 · NDA 214665 · SOTORASIB

    ODE-507 exclusivity

    exclusivity.txt lines 1,361, 1,365, 1,369
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002, 003
  • 21 Jan 2032 · NDA 214759 · TREOSULFAN

    ODE-513 exclusivity

    exclusivity.txt lines 1,383, 1,386
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002
  • 21 Jan 2032 · NDA 214759 · TREOSULFAN

    ODE-514 exclusivity

    exclusivity.txt lines 1,384, 1,387
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002
  • 7 Feb 2032 · NDA 210867 · MOXIDECTIN

    ODE-528 exclusivity

    exclusivity.txt line 922
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001
  • 11 Feb 2032 · NDA 219379 · MIRDAMETINIB

    ODE-488 exclusivity

    exclusivity.txt line 2,273
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001
  • 11 Feb 2032 · NDA 219379 · MIRDAMETINIB

    ODE* exclusivity

    exclusivity.txt lines 2,275, 2,277
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    002, 003
  • 11 Feb 2032 · NDA 219389 · MIRDAMETINIB

    ODE-488 exclusivity

    exclusivity.txt lines 2,279, 2,281
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002
  • 21 Feb 2032 · NDA 219488 · CHENODIOL

    ODE-523 exclusivity

    exclusivity.txt line 2,298
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001
  • 20 Mar 2032 · NDA 215515 · VUTRISIRAN SODIUM

    ODE-527 exclusivity

    exclusivity.txt line 1,590
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001
  • 20 Mar 2032 · NDA 218276 · IPTACOPAN HYDROCHLORIDE

    ODE-524 exclusivity

    exclusivity.txt line 2,141
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001
  • 26 Mar 2032 · NDA 208692 · CABOZANTINIB S-MALATE

    ODE-530 exclusivity

    exclusivity.txt lines 740, 743, 746
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002, 003
  • 26 Mar 2032 · NDA 216665 · DIAZOXIDE CHOLINE

    ODE-532 exclusivity

    exclusivity.txt lines 1,778, 1,780, 1,782
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002, 003
  • 27 Mar 2032 · NDA 215842 · NEDOSIRAN SODIUM

    ODE-531 exclusivity

    exclusivity.txt lines 1,616, 1,620, 1,624
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002, 003
  • 28 Mar 2032 · NDA 219019 · FITUSIRAN SODIUM

    ODE-510 exclusivity

    exclusivity.txt lines 2,231, 2,234
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002
  • 28 Mar 2032 · NDA 219019 · FITUSIRAN SODIUM

    ODE-511 exclusivity

    exclusivity.txt lines 2,232, 2,235
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002
  • 15 Apr 2032 · NDA 212801 · OSILODROSTAT PHOSPHATE

    ODE-535 exclusivity

    exclusivity.txt lines 1,115, 1,117, 1,119
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002, 003
  • 26 Apr 2032 · NDA 215888 · OTESECONAZOLE

    GAIN exclusivity

    exclusivity.txt line 1,669
    Definition
    Generating Antibiotic Incentives Now (to be checked against FDA's list)
    Product numbers
    001
  • 28 Apr 2032 · NDA 211675 · UPADACITINIB

    ODE-538 exclusivity

    exclusivity.txt line 988
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001
  • 3 May 2032 · NDA 215151 · VONOPRAZAN FUMARATE

    GAIN exclusivity

    exclusivity.txt lines 1,476, 1,480
    Definition
    Generating Antibiotic Incentives Now (to be checked against FDA's list)
    Product numbers
    001, 002
  • 3 May 2032 · NDA 215152 · AMOXICILLIN; CLARITHROMYCIN; VONOPRAZAN FUMARATE

    GAIN exclusivity

    exclusivity.txt line 1,483
    Definition
    Generating Antibiotic Incentives Now (to be checked against FDA's list)
    Product numbers
    001
  • 3 May 2032 · NDA 215153 · AMOXICILLIN; VONOPRAZAN FUMARATE

    GAIN exclusivity

    exclusivity.txt line 1,485
    Definition
    Generating Antibiotic Incentives Now (to be checked against FDA's list)
    Product numbers
    001
  • 8 May 2032 · NDA 219616 · AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE

    ODE-525 exclusivity

    exclusivity.txt line 2,302
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001
  • 10 Jun 2032 · NDA 209449 · NITISINONE

    ODE-529 exclusivity

    exclusivity.txt line 786
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    004
  • 11 Jun 2032 · NDA 219713 · TALETRECTINIB ADIPATE

    ODE-544 exclusivity

    exclusivity.txt line 2,321
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001
  • 20 Jun 2032 · NDA 208215 · EMTRICITABINE; TENOFOVIR ALAFENAMIDE FUMARATE

    ODE-556 exclusivity

    exclusivity.txt lines 697, 700
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002