Skip to content
Drybench

Drybench Patent.

BUPROPION HYDROCHLORIDE; DEXTROMETHORPHAN HYDROBROMIDE, NDA 215430

The patents and exclusivities FDA's Orange Book lists for NDA 215430 as captured on 14 October 2026, each date named by its rule and its rows, and the rows of FDA's Paragraph IV list that give this NDA's number, as captured on 17 October 2026. Listed protection is a range of dates, never one date.

FDA capture · review pending. Each row is shown as captured from FDA's Orange Book files and Paragraph IV list. Dates are FDA's own; spreadsheet day numbers are shown as dates, and a cell that cannot be read as one date is shown as written and left out of the range. Where FDA lists a *PED row without flags, its flags are read from the base row and marked so. A Paragraph IV row is placed here only by the number in its RLD/NDA cell; nothing is joined by name. How this page reads FDA's files has not been independently reviewed by a regulatory-affairs reviewer.

Orange Book captured
14 October 2026
Paragraph IV list captured
17 October 2026
Last checked
30 October 2026
Data-branch commit
dadcab56563716abea6c5e31a5e1970080c778ef

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

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.

Open in the app

Listed protection

Listed dates run from 30 Apr 2029 to 28 Nov 2043, each by its own rule; no one date stands for this product.

Earliest listed date
30 Apr 2029I-913 exclusivityRule R3 · Products 001, 002 · exclusivity.txt lines 1,563–1,564
Latest listed date
28 Nov 2043US 12,653,795, use patentRule R1 · Product 001 · patent.txt line 17,077
Latest substance patent
None listed
Latest listed patent
28 Nov 2043US 12,653,795, use patentRule R1 · Product 001 · patent.txt line 17,077
Latest exclusivity
30 Apr 2029I-913 exclusivityRule R3 · Products 001, 002 · exclusivity.txt lines 1,563–1,564

265 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 215430, as listed. The sections below name products by these numbers.

  • Product 001 · AUVELITY

    Dosage form; route
    TABLET, EXTENDED RELEASE;ORAL
    Strength
    105MG;45MG
    Approval date as listed
    18 Aug 2022
    Type as listed
    RX
    Applicant as listed
    AXSOME THERAPEUTICS INC

  • Product 002 · AUVELITY

    Dosage form; route
    TABLET, EXTENDED RELEASE;ORAL
    Strength
    105MG;30MG
    Approval date as listed
    30 Apr 2026
    Type as listed
    RX
    Applicant as listed
    AXSOME THERAPEUTICS INC

Listed patents

Every patent the FDA lists for this product, as the application holder submitted it, with its flags. The FDA does not verify listings.

212 entries from 268 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 8,569,328, product and use patent

    patent.txt line 17,080
    Expiry as listed
    18 Jul 2032
    Rule
    R1
    Flags
    product · use code U-3419
    Product numbers
    001

  • US 8,569,328, product and use patent

    patent.txt lines 17,081, 17,158
    Expiry as listed
    18 Jul 2032
    Rule
    R1
    Flags
    product · use code U-4516
    Product numbers
    001, 002

  • US 10,058,518, use patent

    patent.txt line 16,912
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,058,518, use patent

    patent.txt lines 16,913, 17,124
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4522
    Product numbers
    001, 002

  • US 10,064,857, use patent

    patent.txt line 16,914
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,064,857, use patent

    patent.txt lines 16,915, 17,125
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 10,080,727, use patent

    patent.txt line 16,916
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,080,727, use patent

    patent.txt lines 16,917, 17,126
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4520
    Product numbers
    001, 002

  • US 10,092,560, use patent

    patent.txt line 16,918
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,092,560, use patent

    patent.txt lines 16,919, 17,127
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 10,092,561, use patent

    patent.txt line 16,920
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,092,561, use patent

    patent.txt lines 16,921, 17,128
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 10,105,327, use patent

    patent.txt line 16,922
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,105,361, use patent

    patent.txt line 16,923
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,105,361, use patent

    patent.txt lines 16,924, 17,129
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4522
    Product numbers
    001, 002

  • US 10,251,879, use patent

    patent.txt line 16,925
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,251,879, use patent

    patent.txt lines 16,926, 17,130
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 10,463,634, use patent

    patent.txt line 16,927
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,463,634, use patent

    patent.txt lines 16,928, 17,131
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 10,512,643, use patent

    patent.txt line 16,929
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,512,643, use patent

    patent.txt lines 16,930, 17,132
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 10,548,857, use patent

    patent.txt line 16,931
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,596,167, use patent

    patent.txt line 16,932
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,596,167, use patent

    patent.txt line 16,933
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001

  • US 10,772,850, use patent

    patent.txt line 16,934
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,780,066, use patent

    patent.txt line 16,936
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,780,066, use patent

    patent.txt lines 16,937, 17,133
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 10,786,469, use patent

    patent.txt line 16,938
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,786,496, use patent

    patent.txt line 16,939
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,786,496, use patent

    patent.txt line 16,940
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001

  • US 10,799,497, use patent

    patent.txt line 16,941
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,806,710, use patent

    patent.txt line 16,942
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,806,710, use patent

    patent.txt line 16,943
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001

  • US 10,864,209, use patent

    patent.txt line 16,944
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,874,663, use patent

    patent.txt line 16,945
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,874,664, use patent

    patent.txt line 16,946
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,874,665, use patent

    patent.txt line 16,947
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,881,624, use patent

    patent.txt line 16,948
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,881,624, use patent

    patent.txt lines 16,949, 17,134
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 10,881,657, use patent

    patent.txt line 16,950
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,894,046, use patent

    patent.txt line 16,951
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,894,047, use patent

    patent.txt line 16,952
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,898,453, use patent

    patent.txt line 16,953
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,933,034, use patent

    patent.txt line 16,955
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,945,973, use patent

    patent.txt line 16,957
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,966,941, use patent

    patent.txt line 16,958
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,966,941, use patent

    patent.txt line 16,959
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001

  • US 10,966,974, use patent

    patent.txt line 16,961
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,007,189, use patent

    patent.txt lines 16,962, 17,135
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4516
    Product numbers
    001, 002

  • US 11,020,389, use patent

    patent.txt line 16,963
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,058,648, use patent

    patent.txt line 16,964
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,065,248, use patent

    patent.txt line 16,965
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,065,248, use patent

    patent.txt line 16,966
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001

  • US 11,090,300, use patent

    patent.txt line 16,967
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,096,937, use patent

    patent.txt line 16,968
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,123,343, use patent

    patent.txt line 16,969
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,123,344, use patent

    patent.txt line 16,970
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,123,344, use patent

    patent.txt line 16,971
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001

  • US 11,129,826, use patent

    patent.txt line 16,972
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,141,388, use patent

    patent.txt line 16,973
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,141,416, use patent

    patent.txt line 16,974
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,147,808, use patent

    patent.txt line 16,975
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,185,515, use patent

    patent.txt line 16,976
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,191,739, product and use patent

    patent.txt line 16,977
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    product · use code U-3419
    Product numbers
    001

  • US 11,191,739, product and use patent

    patent.txt line 16,978
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    product · use code U-4516
    Product numbers
    001

  • US 11,197,839, product and use patent

    patent.txt line 16,979
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    product · use code U-3419
    Product numbers
    001

  • US 11,197,839, product and use patent

    patent.txt line 16,980
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    product · use code U-4516
    Product numbers
    001

  • US 11,207,281, use patent

    patent.txt line 16,981
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,207,281, use patent

    patent.txt lines 16,982, 17,136
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4537
    Product numbers
    001, 002

  • US 11,213,521, use patent

    patent.txt line 16,983
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,229,640, use patent

    patent.txt line 16,984
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,234,946, use patent

    patent.txt line 16,985
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,234,946, use patent

    patent.txt lines 16,986, 17,137
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4526
    Product numbers
    001, 002

  • US 11,253,491, use patent

    patent.txt line 16,987
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,253,492, use patent

    patent.txt line 16,988
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,253,492, use patent

    patent.txt lines 16,989, 17,138
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4526
    Product numbers
    001, 002

  • US 11,273,133, use patent

    patent.txt line 16,990
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,273,133, use patent

    patent.txt lines 16,991, 17,139
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4526
    Product numbers
    001, 002

  • US 11,273,134, use patent

    patent.txt line 16,992
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,273,134, use patent

    patent.txt lines 16,993, 17,140
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 11,285,118, use patent

    patent.txt line 16,994
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,285,118, use patent

    patent.txt lines 16,995, 17,141
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4526
    Product numbers
    001, 002

  • US 11,285,146, use patent

    patent.txt line 16,996
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,285,146, use patent

    patent.txt lines 16,997, 17,142
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 11,291,638, use patent

    patent.txt line 16,998
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,291,638, use patent

    patent.txt lines 16,999, 17,143
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 11,291,665, use patent

    patent.txt line 17,000
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,291,665, use patent

    patent.txt lines 17,001, 17,144
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 11,298,351, use patent

    patent.txt line 17,002
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,298,352, use patent

    patent.txt line 17,003
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,298,352, use patent

    patent.txt lines 17,004, 17,145
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 11,311,534, use patent

    patent.txt line 17,005
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,344,544, use patent

    patent.txt line 17,006
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,344,544, use patent

    patent.txt lines 17,007, 17,146
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 11,357,744, use patent

    patent.txt line 17,008
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,357,744, use patent

    patent.txt line 17,009
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001

  • US 11,364,233, use patent

    patent.txt line 17,010
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,382,874, use patent

    patent.txt line 17,011
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,382,874, use patent

    patent.txt lines 17,012, 17,147
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 11,419,867, use patent

    patent.txt line 17,013
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,419,867, use patent

    patent.txt lines 17,014, 17,148
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 11,426,370, use patent

    patent.txt line 17,015
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,426,370, use patent

    patent.txt lines 17,016, 17,149
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4526
    Product numbers
    001, 002

  • US 11,426,401, use patent

    patent.txt line 17,017
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,426,401, use patent

    patent.txt line 17,018
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001

  • US 11,433,067, product and use patent

    patent.txt line 17,019
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    product · use code U-3419
    Product numbers
    001

  • US 11,433,067, product and use patent

    patent.txt line 17,020
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    product · use code U-4516
    Product numbers
    001

  • US 11,439,636, use patent

    patent.txt line 17,021
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,439,636, use patent

    patent.txt line 17,022
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001

  • US 11,478,468, use patent

    patent.txt line 17,023
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,497,721, use patent

    patent.txt line 17,024
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,510,918, use patent

    patent.txt line 17,025
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,517,542, use patent

    patent.txt line 17,026
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,517,543, use patent

    patent.txt line 17,027
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,524,007, use patent

    patent.txt line 17,028
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,524,008, use patent

    patent.txt line 17,029
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,534,414, product and use patent

    patent.txt line 17,030
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    product · use code U-3419
    Product numbers
    001

  • US 11,534,414, product and use patent

    patent.txt line 17,031
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    product · use code U-4516
    Product numbers
    001

  • US 11,541,021, use patent

    patent.txt line 17,032
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,541,048, use patent

    patent.txt line 17,033
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,571,417, use patent

    patent.txt line 17,034
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,571,417, use patent

    patent.txt lines 17,035, 17,150
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4526
    Product numbers
    001, 002

  • US 11,576,909, use patent

    patent.txt line 17,036
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,576,909, use patent

    patent.txt line 17,037
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4526
    Product numbers
    001

  • US 11,590,124, use patent

    patent.txt line 17,038
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,590,124, use patent

    patent.txt lines 17,039, 17,151
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4526
    Product numbers
    001, 002

  • US 11,596,627, use patent

    patent.txt line 17,040
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,617,728, use patent

    patent.txt line 17,041
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,617,747, use patent

    patent.txt line 17,042
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3563
    Product numbers
    001

  • US 11,617,747, use patent

    patent.txt lines 17,043, 17,152
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4526
    Product numbers
    001, 002

  • US 11,779,579, use patent

    patent.txt line 17,047
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,969,421, use patent

    patent.txt line 17,053
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 12,109,178, use patent

    patent.txt line 17,057
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,168,234, use patent

    patent.txt line 17,082
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,168,234, use patent

    patent.txt lines 17,083, 17,159
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 9,198,905, use patent

    patent.txt line 17,084
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,198,905, use patent

    patent.txt lines 17,085, 17,160
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4520
    Product numbers
    001, 002

  • US 9,205,083, use patent

    patent.txt line 17,086
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,205,083, use patent

    patent.txt lines 17,087, 17,161
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4520
    Product numbers
    001, 002

  • US 9,238,032, use patent

    patent.txt line 17,088
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,238,032, use patent

    patent.txt lines 17,089, 17,162
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4520
    Product numbers
    001, 002

  • US 9,278,095, use patent

    patent.txt line 17,090
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,278,095, use patent

    patent.txt lines 17,091, 17,163
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 9,314,462, use patent

    patent.txt line 17,092
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,314,462, use patent

    patent.txt lines 17,093, 17,164
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 9,370,513, use patent

    patent.txt line 17,094
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,370,513, use patent

    patent.txt lines 17,095, 17,165
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4520
    Product numbers
    001, 002

  • US 9,375,429, use patent

    patent.txt line 17,096
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,375,429, use patent

    patent.txt lines 17,097, 17,166
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 9,408,815, use patent

    patent.txt line 17,098
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,408,815, use patent

    patent.txt lines 17,099, 17,167
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 9,421,176, use patent

    patent.txt line 17,100
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,421,176, use patent

    patent.txt lines 17,101, 17,168
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 9,457,023, use patent

    patent.txt line 17,102
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,457,023, use patent

    patent.txt lines 17,103, 17,169
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 9,457,025, use patent

    patent.txt line 17,104
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,457,025, use patent

    patent.txt lines 17,105, 17,170
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 9,474,731, use patent

    patent.txt line 17,106
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,474,731, use patent

    patent.txt lines 17,107, 17,171
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4520
    Product numbers
    001, 002

  • US 9,486,450, use patent

    patent.txt line 17,108
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,486,450, use patent

    patent.txt lines 17,109, 17,172
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 9,700,528, use patent

    patent.txt line 17,110
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,700,528, use patent

    patent.txt lines 17,111, 17,173
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 9,700,553, use patent

    patent.txt line 17,112
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,700,553, use patent

    patent.txt lines 17,113, 17,174
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 9,707,191, use patent

    patent.txt line 17,114
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,707,191, use patent

    patent.txt lines 17,115, 17,175
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4522
    Product numbers
    001, 002

  • US 9,763,932, use patent

    patent.txt line 17,116
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,763,932, use patent

    patent.txt lines 17,117, 17,176
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 9,861,595, use patent

    patent.txt line 17,118
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,861,595, use patent

    patent.txt lines 17,119, 17,177
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 9,867,819, use patent

    patent.txt line 17,120
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,867,819, use patent

    patent.txt lines 17,121, 17,178
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 9,968,568, use patent

    patent.txt line 17,122
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 9,968,568, use patent

    patent.txt lines 17,123, 17,179
    Expiry as listed
    5 Nov 2034
    Rule
    R1
    Flags
    use code U-4517
    Product numbers
    001, 002

  • US 10,780,064, use patent

    patent.txt line 16,935
    Expiry as listed
    7 Jan 2040
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,925,842, use patent

    patent.txt line 16,954
    Expiry as listed
    7 Jan 2040
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,940,124, use patent

    patent.txt line 16,956
    Expiry as listed
    7 Jan 2040
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 10,966,942, use patent

    patent.txt line 16,960
    Expiry as listed
    7 Jan 2040
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 12,433,884, use patent

    patent.txt lines 17,069, 17,153
    Expiry as listed
    5 Jun 2040
    Rule
    R1
    Flags
    use code U-4514
    Product numbers
    001, 002

  • US 12,472,156, use patent

    patent.txt lines 17,071, 17,154
    Expiry as listed
    5 Jun 2040
    Rule
    R1
    Flags
    use code U-4516
    Product numbers
    001, 002

  • US 12,576,078, use patent

    patent.txt lines 17,075, 17,156
    Expiry as listed
    5 Jun 2040
    Rule
    R1
    Flags
    use code U-4516
    Product numbers
    001, 002

  • US 11,896,563, use patent

    patent.txt line 17,051
    Expiry as listed
    1 Dec 2041
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 12,390,428, use patent

    patent.txt line 17,068
    Expiry as listed
    1 Dec 2041
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,717,518, use patent

    patent.txt line 17,044
    Expiry as listed
    20 Jan 2043
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,925,636, use patent

    patent.txt line 17,052
    Expiry as listed
    20 Jan 2043
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 12,156,914, product patent

    patent.txt line 17,059
    Expiry as listed
    20 Jan 2043
    Rule
    R1
    Flags
    product
    Product numbers
    001

  • US 12,239,642, use patent

    patent.txt line 17,062
    Expiry as listed
    20 Jan 2043
    Rule
    R1
    Flags
    use code U-4515
    Product numbers
    001

  • US 12,263,161, use patent

    patent.txt line 17,063
    Expiry as listed
    20 Jan 2043
    Rule
    R1
    Flags
    use code U-4515
    Product numbers
    001

  • US 12,310,961, use patent

    patent.txt line 17,064
    Expiry as listed
    20 Jan 2043
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 12,357,697, use patent

    patent.txt line 17,065
    Expiry as listed
    20 Jan 2043
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 12,472,174, use patent

    patent.txt lines 17,072, 17,155
    Expiry as listed
    20 Jan 2043
    Rule
    R1
    Flags
    use code U-4515
    Product numbers
    001, 002

  • US 12,478,622, use patent

    patent.txt line 17,073
    Expiry as listed
    20 Jan 2043
    Rule
    R1
    Flags
    use code U-4515
    Product numbers
    001

  • US 12,564,587, use patent

    patent.txt line 17,074
    Expiry as listed
    20 Jan 2043
    Rule
    R1
    Flags
    use code U-4515
    Product numbers
    001

  • US 12,661,408, use patent

    patent.txt line 17,078
    Expiry as listed
    20 Jan 2043
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 12,678,506, product patent

    patent.txt lines 17,079, 17,157
    Expiry as listed
    20 Jan 2043
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002

  • US 11,730,706, use patent

    patent.txt line 17,045
    Expiry as listed
    23 Jan 2043
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,883,373, use patent

    patent.txt line 17,050
    Expiry as listed
    23 Jan 2043
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 12,194,005, use patent

    patent.txt line 17,060
    Expiry as listed
    23 Jan 2043
    Rule
    R1
    Flags
    use code U-4523
    Product numbers
    001

  • US 12,364,674, use patent

    patent.txt line 17,066
    Expiry as listed
    23 Jan 2043
    Rule
    R1
    Flags
    use code U-4516
    Product numbers
    001

  • US 11,986,444, use patent

    patent.txt line 17,054
    Expiry as listed
    15 Feb 2043
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 12,036,191, use patent

    patent.txt line 17,055
    Expiry as listed
    15 Feb 2043
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 12,370,154, use patent

    patent.txt line 17,067
    Expiry as listed
    15 Feb 2043
    Rule
    R1
    Flags
    use code U-4518
    Product numbers
    001

  • US 12,599,576, use patent

    patent.txt line 17,076
    Expiry as listed
    15 Feb 2043
    Rule
    R1
    Flags
    use code U-4518
    Product numbers
    001

  • US 11,752,144, use patent

    patent.txt line 17,046
    Expiry as listed
    23 Feb 2043
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 12,042,473, use patent

    patent.txt line 17,056
    Expiry as listed
    23 Feb 2043
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 12,146,889, use patent

    patent.txt line 17,058
    Expiry as listed
    23 Feb 2043
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 12,472,155, use patent

    patent.txt line 17,070
    Expiry as listed
    23 Feb 2043
    Rule
    R1
    Flags
    use code U-4519
    Product numbers
    001

  • US 11,839,612, use patent

    patent.txt line 17,048
    Expiry as listed
    2 Mar 2043
    Rule
    R1
    Flags
    use code U-3419
    Product numbers
    001

  • US 11,844,797, use patent

    patent.txt line 17,049
    Expiry as listed
    20 Apr 2043
    Rule
    R1
    Flags
    use code U-3778
    Product numbers
    001

  • US 12,194,036, use patent

    patent.txt line 17,061
    Expiry as listed
    20 Apr 2043
    Rule
    R1
    Flags
    use code U-4521
    Product numbers
    001

  • US 12,653,795, use patent

    patent.txt line 17,077
    Expiry as listed
    28 Nov 2043
    Rule
    R1
    Flags
    use code U-4516
    Product numbers
    001

Listed exclusivities

Each exclusivity FDA lists for NDA 215430, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

  • I-913 exclusivity

    exclusivity.txt lines 1,563–1,564
    Date
    30 Apr 2029
    Rule
    R3
    Definition
    New indication (to be checked against FDA's list)
    Product numbers
    001, 002

Paragraph IV list rows giving NDA 215430

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 215430, each cell as listed.

FDA's Paragraph IV list names no patent number, so it does not say which of the patents on this page an applicant certified against.

The list gives the last qualifying patent's expiry without pediatric exclusivity; in the app's Patents view, the Orange Book lists any *PED period as a separate row with its own date. The two dates describe different things. A blank cell is one FDA left blank in its list. Dates are FDA's own; the last qualifying patent expiry is not recomputed from the Orange Book.

Rows whose RLD/NDA cell we could not read as exactly one NDA number are kept apart on the list page; some may concern this product.

Rows on FDA's Paragraph IV list whose RLD/NDA cell gives NDA 215430

  • Dextromethorphan Hydrobromide and Bupropion Hydrochloride · Extended-release Tablet · 45 mg/105 mg

    RLD/NDA as listed: Auvelity 215430
    First PIV submission
    22 Dec 2022
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    7 Jan 2040

Notes from the trace

  • R6 tentative approvals: not in the Orange Book data files as captured; the Drugs@FDA join is a later ruling.

Patents vs FDA exclusivityHow to read the Orange Book data filesParagraph IV certificationWhat changed, by week