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UPADACITINIB, NDA 211675

The patents and exclusivities FDA's Orange Book lists for NDA 211675 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 appUPADACITINIB in the molecule app

Listed protection

Listed dates run from 18 May 2026 to 9 Mar 2038, each by its own rule; no one date stands for this product.

Earliest listed date
18 May 2026I-919 exclusivityRule R3 · Products 001, 002, 003 · exclusivity.txt lines 983, 989, 993
Latest listed date
9 Mar 2038US 11,607,411, use patentRule R1 · Products 001, 002, 003 · patent.txt lines 12,991, 13,036, 13,057
Latest substance patent
17 Oct 2036US 9,951,080, substance and product patentRule R1 · Products 001, 002, 003 · patent.txt lines 13,022, 13,048, 13,067
Latest listed patent
9 Mar 2038US 11,607,411, use patentRule R1 · Products 001, 002, 003 · patent.txt lines 12,991, 13,036, 13,057
Latest exclusivity
28 Apr 2032ODE-538 exclusivityRule R3 · Product 001 · exclusivity.txt line 988

50 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 211675, as listed. The sections below name products by these numbers.

  • Product 001 · RINVOQ

    Dosage form; route
    TABLET, EXTENDED RELEASE;ORAL
    Strength
    15MG
    Approval date as listed
    16 Aug 2019
    Type as listed
    RX
    Applicant as listed
    ABBVIE INC

  • Product 002 · RINVOQ

    Dosage form; route
    TABLET, EXTENDED RELEASE;ORAL
    Strength
    30MG
    Approval date as listed
    14 Jan 2022
    Type as listed
    RX
    Applicant as listed
    ABBVIE INC

  • Product 003 · RINVOQ

    Dosage form; route
    TABLET, EXTENDED RELEASE;ORAL
    Strength
    45MG
    Approval date as listed
    16 Mar 2022
    Type as listed
    RX
    Applicant as listed
    ABBVIE 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.

61 entries from 97 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 8,962,629, substance and use patent

    patent.txt line 13,015
    Expiry as listed
    15 Jan 2031
    Rule
    R1
    Flags
    substance · use code U-3255
    Product numbers
    001

  • US 8,962,629, substance and use patent

    patent.txt line 13,016
    Expiry as listed
    15 Jan 2031
    Rule
    R1
    Flags
    substance · use code U-3275
    Product numbers
    001

  • US 8,962,629, substance and use patent

    patent.txt line 13,018
    Expiry as listed
    15 Jan 2031
    Rule
    R1
    Flags
    substance · use code U-3371
    Product numbers
    001

  • US 8,962,629, substance and use patent

    patent.txt line 13,020
    Expiry as listed
    15 Jan 2031
    Rule
    R1
    Flags
    substance · use code U-3945
    Product numbers
    001

  • US 8,962,629, substance and use patent

    patent.txt line 13,021
    Expiry as listed
    15 Jan 2031
    Rule
    R1
    Flags
    substance · use code U-3946
    Product numbers
    001

  • US 8,962,629, substance and use patent

    patent.txt lines 13,017, 13,046, 13,065
    Expiry as listed
    15 Jan 2031
    Rule
    R1
    Flags
    substance · use code U-3341
    Product numbers
    001, 002, 003

  • US 8,962,629, substance and use patent

    patent.txt lines 13,019, 13,047, 13,066
    Expiry as listed
    15 Jan 2031
    Rule
    R1
    Flags
    substance · use code U-3624
    Product numbers
    001, 002, 003

  • US RE47221, substance patent

    patent.txt lines 13,024, 13,049, 13,068
    Expiry as listed
    16 Aug 2033
    Rule
    R1
    Flags
    substance
    Product numbers
    001, 002, 003

  • US 10,202,393, product patent

    patent.txt line 13,050
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    product
    Product numbers
    003

  • US 10,344,036, product patent

    patent.txt line 13,025
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    product
    Product numbers
    002

  • US 10,519,164, product patent

    patent.txt line 12,972
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    product
    Product numbers
    001

  • US 10,550,126, use patent

    patent.txt line 13,026
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3298
    Product numbers
    002

  • US 10,597,400, use patent

    patent.txt line 12,973
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3255
    Product numbers
    001

  • US 10,730,883, product patent

    patent.txt line 13,027
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    product
    Product numbers
    002

  • US 10,981,923, substance patent

    patent.txt lines 12,974, 13,028, 13,051
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    substance
    Product numbers
    001, 002, 003

  • US 10,981,924, product patent

    patent.txt lines 12,975, 13,029
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002

  • US 10,995,095, use patent

    patent.txt line 12,976
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3298
    Product numbers
    001

  • US 11,186,584, substance patent

    patent.txt lines 12,977, 13,030, 13,052
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    substance
    Product numbers
    001, 002, 003

  • US 11,198,697, product patent

    patent.txt lines 12,978, 13,031, 13,053
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003

  • US 11,365,198, use patent

    patent.txt line 12,979
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3275
    Product numbers
    001

  • US 11,365,198, use patent

    patent.txt line 12,980
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3946
    Product numbers
    001

  • US 11,512,092, use patent

    patent.txt line 12,981
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3275
    Product numbers
    001

  • US 11,512,092, use patent

    patent.txt line 12,982
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3371
    Product numbers
    001

  • US 11,512,092, use patent

    patent.txt line 12,983
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3487
    Product numbers
    001

  • US 11,512,092, use patent

    patent.txt line 12,984
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3946
    Product numbers
    001

  • US 11,524,964, use patent

    patent.txt line 12,985
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3371
    Product numbers
    001

  • US 11,535,624, use patent

    patent.txt line 12,986
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3255
    Product numbers
    001

  • US 11,535,625, use patent

    patent.txt line 12,987
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3298
    Product numbers
    001

  • US 11,535,626, use patent

    patent.txt line 13,032
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3298
    Product numbers
    002

  • US 11,661,425, substance and product patent

    patent.txt lines 12,992, 13,037, 13,058
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003

  • US 11,680,069, substance and product patent

    patent.txt lines 12,993, 13,038, 13,059
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003

  • US 11,718,627, substance and product patent

    patent.txt lines 12,994, 13,039, 13,060
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003

  • US 11,767,326, use patent

    patent.txt lines 12,995, 13,040
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3298
    Product numbers
    001, 002

  • US 11,773,105, substance and product patent

    patent.txt lines 12,996, 13,041, 13,061
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003

  • US 11,773,106, use patent

    patent.txt line 12,997
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3275
    Product numbers
    001

  • US 11,773,106, use patent

    patent.txt line 12,998
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3371
    Product numbers
    001

  • US 11,773,106, use patent

    patent.txt line 12,999
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3487
    Product numbers
    001

  • US 11,773,106, use patent

    patent.txt line 13,000
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3946
    Product numbers
    001

  • US 11,780,847, product patent

    patent.txt line 13,001
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    product
    Product numbers
    001

  • US 11,780,848, use patent

    patent.txt line 13,002
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3371
    Product numbers
    001

  • US 11,787,815, product patent

    patent.txt line 13,003
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    product
    Product numbers
    001

  • US 11,795,175, use patent

    patent.txt line 13,004
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3255
    Product numbers
    001

  • US 11,976,077, use patent

    patent.txt line 13,005
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3298
    Product numbers
    001

  • US 11,993,605, use patent

    patent.txt line 13,006
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3275
    Product numbers
    001

  • US 11,993,605, use patent

    patent.txt line 13,007
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3946
    Product numbers
    001

  • US 11,993,606, use patent

    patent.txt line 13,008
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3487
    Product numbers
    001

  • US 12,077,545, product patent

    patent.txt lines 13,009, 13,042, 13,062
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003

  • US 12,091,415, product patent

    patent.txt line 13,043
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    product
    Product numbers
    002

  • US 12,103,933, product patent

    patent.txt line 13,010
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    product
    Product numbers
    001

  • US 12,110,297, product patent

    patent.txt line 13,011
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    product
    Product numbers
    001

  • US 12,110,298, substance and product patent

    patent.txt lines 13,012, 13,044, 13,063
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003

  • US 12,116,373, product patent

    patent.txt line 13,045
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    product
    Product numbers
    002

  • US 12,134,621, product patent

    patent.txt line 13,064
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    product
    Product numbers
    003

  • US 12,365,689, use patent

    patent.txt line 13,013
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-3945
    Product numbers
    001

  • US 12,570,664, use patent

    patent.txt line 13,014
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    use code U-4454
    Product numbers
    001

  • US 9,951,080, substance and product patent

    patent.txt lines 13,022, 13,048, 13,067
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    substance · product
    Product numbers
    001, 002, 003

  • US 9,963,459, product patent

    patent.txt line 13,023
    Expiry as listed
    17 Oct 2036
    Rule
    R1
    Flags
    product
    Product numbers
    001

  • US 11,564,922, use patent

    patent.txt lines 12,988, 13,033, 13,054
    Expiry as listed
    9 Mar 2038
    Rule
    R1
    Flags
    use code U-3624
    Product numbers
    001, 002, 003

  • US 11,564,922, use patent

    patent.txt lines 12,989, 13,034, 13,055
    Expiry as listed
    9 Mar 2038
    Rule
    R1
    Flags
    use code U-4303
    Product numbers
    001, 002, 003

  • US 11,607,411, use patent

    patent.txt lines 12,990, 13,035, 13,056
    Expiry as listed
    9 Mar 2038
    Rule
    R1
    Flags
    use code U-3341
    Product numbers
    001, 002, 003

  • US 11,607,411, use patent

    patent.txt lines 12,991, 13,036, 13,057
    Expiry as listed
    9 Mar 2038
    Rule
    R1
    Flags
    use code U-4302
    Product numbers
    001, 002, 003

Listed exclusivities

Each exclusivity FDA lists for NDA 211675, with its code, FDA's definition of the code where the store's code list gives one, and its date as listed.

  • I-919 exclusivity

    exclusivity.txt lines 983, 989, 993
    Date
    18 May 2026
    Rule
    R3
    Definition
    New indication (to be checked against FDA's list)
    Product numbers
    001, 002, 003

  • I-946 exclusivity

    exclusivity.txt lines 984, 990, 994
    Date
    26 Apr 2027
    Rule
    R3
    Definition
    New indication (to be checked against FDA's list)
    Product numbers
    001, 002, 003

  • NPP exclusivity

    exclusivity.txt lines 986, 991, 995
    Date
    26 Apr 2027
    Rule
    R3
    Definition
    New patient population (to be checked against FDA's list)
    Product numbers
    001, 002, 003

  • I-966 exclusivity

    exclusivity.txt line 985
    Date
    28 Apr 2028
    Rule
    R3
    Definition
    New indication (to be checked against FDA's list)
    Product numbers
    001

  • ODE-481 exclusivity

    exclusivity.txt lines 987, 992, 996
    Date
    26 Apr 2031
    Rule
    R3
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002, 003

  • ODE-538 exclusivity

    exclusivity.txt line 988
    Date
    28 Apr 2032
    Rule
    R3
    Definition
    Orphan drug exclusivity (to be checked against FDA's list)
    Product numbers
    001

Paragraph IV list rows giving NDA 211675

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 211675, 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 211675

  • Upadacitinib · Extended-release Tablets · 15 mg

    RLD/NDA as listed: Rinvoq 211675
    First PIV submission
    16 Aug 2023
    ANDAs
    5
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Mar 2038

  • Upadacitinib · Extended-release Tablets · 30 mg

    RLD/NDA as listed: Rinvoq 211675
    First PIV submission
    16 Aug 2023
    ANDAs
    4
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Mar 2038

  • Upadacitinib · Extended-release Tablets · 45 mg

    RLD/NDA as listed: Rinvoq 211675
    First PIV submission
    16 Aug 2023
    ANDAs
    3
    180-day status
    blank
    Decision posted
    blank
    First applicant approval
    blank
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    9 Mar 2038

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