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IBRUTINIB, NDA 210563

The patents and exclusivities FDA's Orange Book lists for NDA 210563 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.

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Listed protection

Listed dates run from 24 Aug 2025 to 3 Sep 2036, each by its own rule; no one date stands for this product.

Earliest listed date
24 Aug 2025NPP exclusivityRule R3 · Products 001, 002, 003, 004 · exclusivity.txt lines 889, 893, 897, 901
Latest listed date
3 Sep 2036US 9,655,857 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004 · patent.txt lines 11,679, 11,783, 11,887, 11,996
Latest substance patent
30 Apr 2034US 9,296,753 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004 · patent.txt lines 11,677, 11,781, 11,885, 11,994
Latest listed patent
3 Sep 2036US 9,655,857 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003, 004 · patent.txt lines 11,679, 11,783, 11,887, 11,996
Latest exclusivity
24 Feb 2030PED exclusivityRule R3 · Products 001, 002, 003, 004 · exclusivity.txt lines 892, 896, 900, 904

224 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 210563, as listed. The sections below name products by these numbers.

  • Product 001 · IMBRUVICA

    Dosage form; route
    TABLET;ORAL
    Strength
    140MG
    Approval date as listed
    16 Feb 2018
    Type as listed
    RX
    Applicant as listed
    PHARMACYCLICS LLC

  • Product 002 · IMBRUVICA

    Dosage form; route
    TABLET;ORAL
    Strength
    280MG
    Approval date as listed
    16 Feb 2018
    Type as listed
    RX
    Applicant as listed
    PHARMACYCLICS LLC

  • Product 003 · IMBRUVICA

    Dosage form; route
    TABLET;ORAL
    Strength
    420MG
    Approval date as listed
    16 Feb 2018
    Type as listed
    RX
    Applicant as listed
    PHARMACYCLICS LLC

  • Product 004 · IMBRUVICA

    Dosage form; route
    TABLET;ORAL
    Strength
    560MG
    Approval date as listed
    16 Feb 2018
    Type as listed
    DISCN
    Applicant as listed
    PHARMACYCLICS LLC

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.

120 entries from 424 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 7,514,444, substance and product patent

    patent.txt lines 11,631, 11,735, 11,839, 11,941
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003, 004

  • US 8,476,284, use patent

    patent.txt lines 11,635, 11,739, 11,843, 11,946
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-1650
    Product numbers
    001, 002, 003, 004

  • US 8,476,284, use patent

    patent.txt lines 11,636, 11,740, 11,844, 11,947
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-1946
    Product numbers
    001, 002, 003, 004

  • US 8,476,284, use patent

    patent.txt lines 11,637, 11,741, 11,845, 11,949
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-2241
    Product numbers
    001, 002, 003, 004

  • US 8,476,284, use patent

    patent.txt line 11,945
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-1456
    Product numbers
    004

  • US 8,476,284, use patent

    patent.txt line 11,948
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-1947
    Product numbers
    004

  • US 8,497,277, use patent

    patent.txt lines 11,644, 11,748, 11,852
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-3422
    Product numbers
    001, 002, 003

  • US 8,497,277, use patent

    patent.txt lines 11,639, 11,743, 11,847, 11,952
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-1491
    Product numbers
    001, 002, 003, 004

  • US 8,497,277, use patent

    patent.txt lines 11,640, 11,744, 11,848, 11,953
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-1650
    Product numbers
    001, 002, 003, 004

  • US 8,497,277, use patent

    patent.txt lines 11,641, 11,745, 11,849, 11,954
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-1946
    Product numbers
    001, 002, 003, 004

  • US 8,497,277, use patent

    patent.txt lines 11,642, 11,746, 11,850, 11,956
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-2241
    Product numbers
    001, 002, 003, 004

  • US 8,497,277, use patent

    patent.txt lines 11,643, 11,747, 11,851, 11,957
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-2242
    Product numbers
    001, 002, 003, 004

  • US 8,497,277, use patent

    patent.txt line 11,951
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-1456
    Product numbers
    004

  • US 8,497,277, use patent

    patent.txt line 11,955
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-1947
    Product numbers
    004

  • US 8,697,711, substance and product patent

    patent.txt lines 11,652, 11,756, 11,860, 11,965
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003, 004

  • US 8,703,780, use patent

    patent.txt lines 11,654, 11,758, 11,862, 11,967
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-1491
    Product numbers
    001, 002, 003, 004

  • US 8,703,780, use patent

    patent.txt lines 11,655, 11,759, 11,863, 11,968
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-2242
    Product numbers
    001, 002, 003, 004

  • US 8,735,403, substance and product patent

    patent.txt lines 11,657, 11,761, 11,865, 11,970
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003, 004

  • US 8,754,091, product patent

    patent.txt lines 11,659, 11,763, 11,867, 11,974
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003, 004

  • US 8,952,015, use patent

    patent.txt lines 11,661, 11,765, 11,869, 11,977
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-1491
    Product numbers
    001, 002, 003, 004

  • US 8,952,015, use patent

    patent.txt lines 11,662, 11,766, 11,870, 11,978
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-1650
    Product numbers
    001, 002, 003, 004

  • US 8,952,015, use patent

    patent.txt lines 11,663, 11,767, 11,871, 11,979
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-1946
    Product numbers
    001, 002, 003, 004

  • US 8,952,015, use patent

    patent.txt lines 11,664, 11,768, 11,872, 11,981
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-2241
    Product numbers
    001, 002, 003, 004

  • US 8,952,015, use patent

    patent.txt lines 11,665, 11,769, 11,873, 11,982
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-2242
    Product numbers
    001, 002, 003, 004

  • US 8,952,015, use patent

    patent.txt line 11,976
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-1456
    Product numbers
    004

  • US 8,952,015, use patent

    patent.txt line 11,980
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    use code U-1947
    Product numbers
    004

  • US 8,957,079, substance and product patent

    patent.txt lines 11,667, 11,771, 11,875, 11,984
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003, 004

  • US 9,181,257, substance patent

    patent.txt lines 11,676, 11,780, 11,884, 11,993
    Expiry as listed
    28 Dec 2026
    Rule
    R1
    Flags
    substance
    Product numbers
    001, 002, 003, 004

  • US 8,563,563, use patent

    patent.txt lines 11,646, 11,750, 11,854, 11,959
    Expiry as listed
    26 Apr 2027
    Rule
    R1
    Flags
    use code U-1491
    Product numbers
    001, 002, 003, 004

  • US 8,563,563, use patent

    patent.txt lines 11,647, 11,751, 11,855, 11,960
    Expiry as listed
    26 Apr 2027
    Rule
    R1
    Flags
    use code U-1650
    Product numbers
    001, 002, 003, 004

  • US 8,563,563, use patent

    patent.txt lines 11,648, 11,752, 11,856, 11,961
    Expiry as listed
    26 Apr 2027
    Rule
    R1
    Flags
    use code U-1946
    Product numbers
    001, 002, 003, 004

  • US 8,563,563, use patent

    patent.txt lines 11,649, 11,753, 11,857, 11,962
    Expiry as listed
    26 Apr 2027
    Rule
    R1
    Flags
    use code U-2241
    Product numbers
    001, 002, 003, 004

  • US 8,563,563, use patent

    patent.txt lines 11,650, 11,754, 11,858, 11,963
    Expiry as listed
    26 Apr 2027
    Rule
    R1
    Flags
    use code U-2242
    Product numbers
    001, 002, 003, 004

  • US 7,514,444 with pediatric exclusivity, as listed

    patent.txt lines 11,630, 11,734, 11,838, 11,940
    Expiry as listed
    28 Jun 2027
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 8,476,284 with pediatric exclusivity, as listed

    patent.txt lines 11,634, 11,738, 11,842, 11,944
    Expiry as listed
    28 Jun 2027
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 8,497,277 with pediatric exclusivity, as listed

    patent.txt lines 11,638, 11,742, 11,846, 11,950
    Expiry as listed
    28 Jun 2027
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 8,697,711 with pediatric exclusivity, as listed

    patent.txt lines 11,651, 11,755, 11,859, 11,964
    Expiry as listed
    28 Jun 2027
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 8,703,780 with pediatric exclusivity, as listed

    patent.txt lines 11,653, 11,757, 11,861, 11,966
    Expiry as listed
    28 Jun 2027
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 8,735,403 with pediatric exclusivity, as listed

    patent.txt lines 11,656, 11,760, 11,864, 11,969
    Expiry as listed
    28 Jun 2027
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 8,754,091 with pediatric exclusivity, as listed

    patent.txt lines 11,658, 11,762, 11,866, 11,973
    Expiry as listed
    28 Jun 2027
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 8,952,015 with pediatric exclusivity, as listed

    patent.txt lines 11,660, 11,764, 11,868, 11,975
    Expiry as listed
    28 Jun 2027
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 8,957,079 with pediatric exclusivity, as listed

    patent.txt lines 11,666, 11,770, 11,874, 11,983
    Expiry as listed
    28 Jun 2027
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 9,181,257 with pediatric exclusivity, as listed

    patent.txt lines 11,675, 11,779, 11,883, 11,992
    Expiry as listed
    28 Jun 2027
    Rule
    R2
    Flags
    substance · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 8,563,563 with pediatric exclusivity, as listed

    patent.txt lines 11,645, 11,749, 11,853, 11,958
    Expiry as listed
    26 Oct 2027
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 8,008,309, substance and product patent

    patent.txt lines 11,633, 11,737, 11,841, 11,943
    Expiry as listed
    13 Nov 2027
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003, 004

  • US 8,008,309 with pediatric exclusivity, as listed

    patent.txt lines 11,632, 11,736, 11,840, 11,942
    Expiry as listed
    13 May 2028
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 10,004,746, use patent

    patent.txt lines 11,588, 11,694, 11,798, 11,902
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1684
    Product numbers
    001, 002, 003, 004

  • US 10,004,746, use patent

    patent.txt lines 11,589, 11,695, 11,799, 11,903
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1946
    Product numbers
    001, 002, 003, 004

  • US 10,004,746, use patent

    patent.txt lines 11,590, 11,696, 11,800, 11,904
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-2241
    Product numbers
    001, 002, 003, 004

  • US 10,004,746, use patent

    patent.txt lines 11,591, 11,697, 11,801, 11,905
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-2242
    Product numbers
    001, 002, 003, 004

  • US 10,016,435, use patent

    patent.txt lines 11,595, 11,701, 11,805, 11,909
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1650
    Product numbers
    001, 002, 003, 004

  • US 10,478,439, use patent

    patent.txt lines 11,611, 11,717, 11,821
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-3422
    Product numbers
    001, 002, 003

  • US 10,478,439, use patent

    patent.txt lines 11,605, 11,711, 11,815, 11,920
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1650
    Product numbers
    001, 002, 003, 004

  • US 10,478,439, use patent

    patent.txt lines 11,606, 11,712, 11,816, 11,921
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1684
    Product numbers
    001, 002, 003, 004

  • US 10,478,439, use patent

    patent.txt lines 11,607, 11,713, 11,817, 11,922
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1946
    Product numbers
    001, 002, 003, 004

  • US 10,478,439, use patent

    patent.txt lines 11,608, 11,714, 11,818, 11,924
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-2241
    Product numbers
    001, 002, 003, 004

  • US 10,478,439, use patent

    patent.txt lines 11,609, 11,715, 11,819, 11,925
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-2242
    Product numbers
    001, 002, 003, 004

  • US 10,478,439, use patent

    patent.txt lines 11,610, 11,716, 11,820, 11,926
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-2665
    Product numbers
    001, 002, 003, 004

  • US 10,478,439, use patent

    patent.txt line 11,919
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1456
    Product numbers
    004

  • US 10,478,439, use patent

    patent.txt line 11,923
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1947
    Product numbers
    004

  • US 10,653,696, use patent

    patent.txt line 11,928
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1456
    Product numbers
    004

  • US 10,751,342, use patent

    patent.txt lines 11,615, 11,721, 11,825, 11,932
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1491
    Product numbers
    001, 002, 003, 004

  • US 10,751,342, use patent

    patent.txt lines 11,616, 11,722, 11,826, 11,933
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1946
    Product numbers
    001, 002, 003, 004

  • US 10,751,342, use patent

    patent.txt lines 11,617, 11,723, 11,827, 11,934
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-2943
    Product numbers
    001, 002, 003, 004

  • US 10,751,342, use patent

    patent.txt lines 11,618, 11,724, 11,828, 11,935
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-2944
    Product numbers
    001, 002, 003, 004

  • US 11,672,803, use patent

    patent.txt lines 11,625, 11,729, 11,833
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1684
    Product numbers
    001, 002, 003

  • US 11,672,803, use patent

    patent.txt lines 11,626, 11,730, 11,834
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1946
    Product numbers
    001, 002, 003

  • US 11,672,803, use patent

    patent.txt lines 11,627, 11,731, 11,835
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-2241
    Product numbers
    001, 002, 003

  • US 11,672,803, use patent

    patent.txt lines 11,628, 11,732, 11,836
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-2242
    Product numbers
    001, 002, 003

  • US 8,754,090, use patent

    patent.txt line 11,972
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1456
    Product numbers
    004

  • US 8,999,999, use patent

    patent.txt lines 11,669, 11,773, 11,877, 11,986
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1491
    Product numbers
    001, 002, 003, 004

  • US 8,999,999, use patent

    patent.txt lines 11,670, 11,774, 11,878, 11,987
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1946
    Product numbers
    001, 002, 003, 004

  • US 8,999,999, use patent

    patent.txt lines 11,671, 11,775, 11,879, 11,988
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-2241
    Product numbers
    001, 002, 003, 004

  • US 8,999,999, use patent

    patent.txt lines 11,672, 11,776, 11,880, 11,989
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-2242
    Product numbers
    001, 002, 003, 004

  • US 9,125,889, use patent

    patent.txt lines 11,674, 11,778, 11,882, 11,991
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1650
    Product numbers
    001, 002, 003, 004

  • US 9,801,881, use patent

    patent.txt lines 11,688, 11,792, 11,896, 12,004
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1491
    Product numbers
    001, 002, 003, 004

  • US 9,801,881, use patent

    patent.txt lines 11,689, 11,793, 11,897, 12,005
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-2242
    Product numbers
    001, 002, 003, 004

  • US 9,801,883, use patent

    patent.txt lines 11,691, 11,795, 11,899, 12,007
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-2159
    Product numbers
    001, 002, 003, 004

  • US 9,801,883, use patent

    patent.txt lines 11,692, 11,796, 11,900, 12,008
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-2243
    Product numbers
    001, 002, 003, 004

  • US 9,814,721, use patent

    patent.txt line 12,010
    Expiry as listed
    3 Jun 2031
    Rule
    R1
    Flags
    use code U-1947
    Product numbers
    004

  • US 10,004,746 with pediatric exclusivity, as listed

    patent.txt lines 11,587, 11,693, 11,797, 11,901
    Expiry as listed
    3 Dec 2031
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 10,016,435 with pediatric exclusivity, as listed

    patent.txt lines 11,594, 11,700, 11,804, 11,908
    Expiry as listed
    3 Dec 2031
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 10,478,439 with pediatric exclusivity, as listed

    patent.txt lines 11,604, 11,710, 11,814, 11,918
    Expiry as listed
    3 Dec 2031
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 10,653,696 with pediatric exclusivity, as listed

    patent.txt line 11,927
    Expiry as listed
    3 Dec 2031
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    004

  • US 10,751,342 with pediatric exclusivity, as listed

    patent.txt lines 11,614, 11,720, 11,824, 11,931
    Expiry as listed
    3 Dec 2031
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 8,754,090 with pediatric exclusivity, as listed

    patent.txt line 11,971
    Expiry as listed
    3 Dec 2031
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    004

  • US 8,999,999 with pediatric exclusivity, as listed

    patent.txt lines 11,668, 11,772, 11,876, 11,985
    Expiry as listed
    3 Dec 2031
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 9,125,889 with pediatric exclusivity, as listed

    patent.txt lines 11,673, 11,777, 11,881, 11,990
    Expiry as listed
    3 Dec 2031
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 9,801,881 with pediatric exclusivity, as listed

    patent.txt lines 11,687, 11,791, 11,895, 12,003
    Expiry as listed
    3 Dec 2031
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 9,801,883 with pediatric exclusivity, as listed

    patent.txt lines 11,690, 11,794, 11,898, 12,006
    Expiry as listed
    3 Dec 2031
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 9,814,721 with pediatric exclusivity, as listed

    patent.txt line 12,009
    Expiry as listed
    3 Dec 2031
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    004

  • US 10,106,548, substance and product patent

    patent.txt lines 11,597, 11,703, 11,807, 11,911
    Expiry as listed
    3 Jun 2033
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003, 004

  • US 10,125,140, substance and product patent

    patent.txt lines 11,599, 11,705, 11,809, 11,913
    Expiry as listed
    3 Jun 2033
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003, 004

  • US 10,752,634, product patent

    patent.txt line 11,620
    Expiry as listed
    3 Jun 2033
    Rule
    R1
    Flags
    product
    Product numbers
    001

  • US 10,961,251, product patent

    patent.txt lines 11,624, 11,728, 11,832, 11,939
    Expiry as listed
    3 Jun 2033
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003, 004

  • US 9,725,455, substance patent

    patent.txt lines 11,682, 11,786, 11,890, 11,999
    Expiry as listed
    3 Jun 2033
    Rule
    R1
    Flags
    substance
    Product numbers
    001, 002, 003, 004

  • US 9,296,753, substance patent

    patent.txt lines 11,678, 11,782, 11,886, 11,995
    Expiry as listed
    30 Oct 2033
    Rule
    R1
    Flags
    substance
    Product numbers
    001, 002, 003, 004

  • US 10,106,548 with pediatric exclusivity, as listed

    patent.txt lines 11,596, 11,702, 11,806, 11,910
    Expiry as listed
    3 Dec 2033
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 10,125,140 with pediatric exclusivity, as listed

    patent.txt lines 11,598, 11,704, 11,808, 11,912
    Expiry as listed
    3 Dec 2033
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 10,752,634 with pediatric exclusivity, as listed

    patent.txt line 11,619
    Expiry as listed
    3 Dec 2033
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001

  • US 10,961,251 with pediatric exclusivity, as listed

    patent.txt lines 11,623, 11,727, 11,831, 11,938
    Expiry as listed
    3 Dec 2033
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 9,725,455 with pediatric exclusivity, as listed

    patent.txt lines 11,681, 11,785, 11,889, 11,998
    Expiry as listed
    3 Dec 2033
    Rule
    R2
    Flags
    substance · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 9,296,753 with pediatric exclusivity, as listed

    patent.txt lines 11,677, 11,781, 11,885, 11,994
    Expiry as listed
    30 Apr 2034
    Rule
    R2
    Flags
    substance · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 10,463,668, use patent

    patent.txt lines 11,603, 11,709, 11,813, 11,917
    Expiry as listed
    24 Oct 2034
    Rule
    R1
    Flags
    use code U-2654
    Product numbers
    001, 002, 003, 004

  • US 10,695,350, use patent

    patent.txt lines 11,613, 11,719, 11,823, 11,930
    Expiry as listed
    24 Oct 2034
    Rule
    R1
    Flags
    use code U-2846
    Product numbers
    001, 002, 003, 004

  • US 9,795,604, use patent

    patent.txt lines 11,686, 11,790, 11,894
    Expiry as listed
    24 Oct 2034
    Rule
    R1
    Flags
    use code U-3422
    Product numbers
    001, 002, 003

  • US 9,795,604, use patent

    patent.txt lines 11,684, 11,788, 11,892, 12,001
    Expiry as listed
    24 Oct 2034
    Rule
    R1
    Flags
    use code U-2969
    Product numbers
    001, 002, 003, 004

  • US 9,795,604, use patent

    patent.txt lines 11,685, 11,789, 11,893, 12,002
    Expiry as listed
    24 Oct 2034
    Rule
    R1
    Flags
    use code U-2970
    Product numbers
    001, 002, 003, 004

  • US 10,463,668 with pediatric exclusivity, as listed

    patent.txt lines 11,602, 11,708, 11,812, 11,916
    Expiry as listed
    24 Apr 2035
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 10,695,350 with pediatric exclusivity, as listed

    patent.txt lines 11,612, 11,718, 11,822, 11,929
    Expiry as listed
    24 Apr 2035
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 9,795,604 with pediatric exclusivity, as listed

    patent.txt lines 11,683, 11,787, 11,891, 12,000
    Expiry as listed
    24 Apr 2035
    Rule
    R2
    Flags
    pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 10,010,507, product patent

    patent.txt lines 11,593, 11,699, 11,803, 11,907
    Expiry as listed
    3 Mar 2036
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003, 004

  • US 10,213,386, product patent

    patent.txt lines 11,601, 11,707, 11,811, 11,915
    Expiry as listed
    3 Mar 2036
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003, 004

  • US 10,828,259, product patent

    patent.txt lines 11,622, 11,726, 11,830, 11,937
    Expiry as listed
    3 Mar 2036
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003, 004

  • US 12,551,448, product patent

    patent.txt lines 11,629, 11,733, 11,837
    Expiry as listed
    3 Mar 2036
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003

  • US 9,655,857, product patent

    patent.txt lines 11,680, 11,784, 11,888, 11,997
    Expiry as listed
    3 Mar 2036
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003, 004

  • US 10,010,507 with pediatric exclusivity, as listed

    patent.txt lines 11,592, 11,698, 11,802, 11,906
    Expiry as listed
    3 Sep 2036
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 10,213,386 with pediatric exclusivity, as listed

    patent.txt lines 11,600, 11,706, 11,810, 11,914
    Expiry as listed
    3 Sep 2036
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 10,828,259 with pediatric exclusivity, as listed

    patent.txt lines 11,621, 11,725, 11,829, 11,936
    Expiry as listed
    3 Sep 2036
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

  • US 9,655,857 with pediatric exclusivity, as listed

    patent.txt lines 11,679, 11,783, 11,887, 11,996
    Expiry as listed
    3 Sep 2036
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003, 004

Listed exclusivities

Each exclusivity FDA lists for NDA 210563, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

  • NPP exclusivity

    exclusivity.txt lines 889, 893, 897, 901
    Date
    24 Aug 2025
    Rule
    R3
    Definition
    New patient population (to be checked against FDA's list)
    Product numbers
    001, 002, 003, 004

  • PED exclusivity

    exclusivity.txt lines 891, 895, 899, 903
    Date
    24 Feb 2026
    Rule
    R3
    Definition
    Pediatric exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002, 003, 004

  • ODE-405 exclusivity

    exclusivity.txt lines 890, 894, 898, 902
    Date
    24 Aug 2029
    Rule
    R3
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002, 003, 004

  • PED exclusivity

    exclusivity.txt lines 892, 896, 900, 904
    Date
    24 Feb 2030
    Rule
    R3
    Definition
    Pediatric exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002, 003, 004

Paragraph IV list rows giving NDA 210563

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 210563, 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 210563

  • Ibrutinib · Tablets · 140 mg

    RLD/NDA as listed: Imbruvica 210563
    First PIV submission
    5 Nov 2018
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    3 Mar 2036

  • Ibrutinib · Tablets · 560 mg

    RLD/NDA as listed: Imbruvica 210563
    First PIV submission
    5 Nov 2018
    ANDAs
    1
    180-day status
    Extinguished
    Decision posted
    8 Jul 2024
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    3 Mar 2036

  • Ibrutinib · Tablets · 280 mg and 420 mg

    RLD/NDA as listed: Imbruvica 210563
    First PIV submission
    14 Dec 2018
    ANDAs
    1
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    3 Mar 2036

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