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Drybench Patent.

APIXABAN, NDA 202155

The patents and exclusivities FDA's Orange Book lists for NDA 202155 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 appAPIXABAN in the molecule app

Listed protection

Listed dates run from 21 Nov 2026 to 24 Aug 2031, each by its own rule; no one date stands for this product.

Earliest listed date
21 Nov 2026US 6,967,208, substance and product and use patentRule R1 · Product 001 · patent.txt line 2,777
Latest listed date
24 Aug 2031US 9,326,945 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003 · patent.txt lines 2,787, 2,795, 2,799
Latest substance patent
21 May 2027US 6,967,208 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003 · patent.txt lines 2,776, 2,789, 2,797
Latest listed patent
24 Aug 2031US 9,326,945 with pediatric exclusivity, as listedRule R2 · Products 001, 002, 003 · patent.txt lines 2,787, 2,795, 2,799
Latest exclusivity
17 Oct 2028PED exclusivityRule R3 · Products 001, 002, 003 · exclusivity.txt lines 232, 234, 236

16 use-code patents, blocking the coded use only

Products

Each product number FDA lists under NDA 202155, as listed. The sections below name products by these numbers.

  • Product 001 · ELIQUIS

    Dosage form; route
    TABLET;ORAL
    Strength
    2.5MG
    Approval date as listed
    28 Dec 2012
    Type as listed
    RX
    Applicant as listed
    BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
  • Product 002 · ELIQUIS

    Dosage form; route
    TABLET;ORAL
    Strength
    5MG
    Approval date as listed
    28 Dec 2012
    Type as listed
    RX
    Applicant as listed
    BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
  • Product 003 · ELIQUIS

    Dosage form; route
    TABLET, FOR SUSPENSION;ORAL
    Strength
    0.5MG
    Approval date as listed
    17 Apr 2025
    Type as listed
    RX
    Applicant as listed
    BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE

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.

14 entries from 25 rows as listed; rows merge only where every cell shown is the same, each with its product numbers.

  • US 6,967,208, substance and product and use patent

    patent.txt line 2,777
    Expiry as listed
    21 Nov 2026
    Rule
    R1
    Flags
    substance · product · use code U-1167
    Product numbers
    001
  • US 6,967,208, substance and product and use patent

    patent.txt line 2,782
    Expiry as listed
    21 Nov 2026
    Rule
    R1
    Flags
    substance · product · use code U-1501
    Product numbers
    001
  • US 6,967,208, substance and product and use patent

    patent.txt line 2,783
    Expiry as listed
    21 Nov 2026
    Rule
    R1
    Flags
    substance · product · use code U-1502
    Product numbers
    001
  • US 6,967,208, substance and product and use patent

    patent.txt line 2,784
    Expiry as listed
    21 Nov 2026
    Rule
    R1
    Flags
    substance · product · use code U-1729
    Product numbers
    001
  • US 6,967,208, substance and product and use patent

    patent.txt line 2,785
    Expiry as listed
    21 Nov 2026
    Rule
    R1
    Flags
    substance · product · use code U-1730
    Product numbers
    001
  • US 6,967,208, substance and product and use patent

    patent.txt lines 2,778, 2,790
    Expiry as listed
    21 Nov 2026
    Rule
    R1
    Flags
    substance · product · use code U-1200
    Product numbers
    001, 002
  • US 6,967,208, substance and product and use patent

    patent.txt lines 2,779, 2,791
    Expiry as listed
    21 Nov 2026
    Rule
    R1
    Flags
    substance · product · use code U-1301
    Product numbers
    001, 002
  • US 6,967,208, substance and product and use patent

    patent.txt lines 2,780, 2,792
    Expiry as listed
    21 Nov 2026
    Rule
    R1
    Flags
    substance · product · use code U-1302
    Product numbers
    001, 002
  • US 6,967,208, substance and product and use patent

    patent.txt lines 2,781, 2,793
    Expiry as listed
    21 Nov 2026
    Rule
    R1
    Flags
    substance · product · use code U-1323
    Product numbers
    001, 002
  • US 6,967,208, substance and product and use patent

    patent.txt lines 2,786, 2,794
    Expiry as listed
    21 Nov 2026
    Rule
    R1
    Flags
    substance · product · use code U-4178
    Product numbers
    001, 002
  • US 6,967,208, substance and product and use patent

    patent.txt line 2,798
    Expiry as listed
    21 Nov 2026
    Rule
    R1
    Flags
    substance · product · use code U-4179
    Product numbers
    003
  • US 6,967,208 with pediatric exclusivity, as listed

    patent.txt lines 2,776, 2,789, 2,797
    Expiry as listed
    21 May 2027
    Rule
    R2
    Flags
    substance · product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003
  • US 9,326,945, product patent

    patent.txt lines 2,788, 2,796, 2,800
    Expiry as listed
    24 Feb 2031
    Rule
    R1
    Flags
    product
    Product numbers
    001, 002, 003
  • US 9,326,945 with pediatric exclusivity, as listed

    patent.txt lines 2,787, 2,795, 2,799
    Expiry as listed
    24 Aug 2031
    Rule
    R2
    Flags
    product · pediatric, as listed by FDA (from the base row)
    Product numbers
    001, 002, 003

Listed exclusivities

Each exclusivity FDA lists for NDA 202155, 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 231, 233
    Date
    17 Apr 2028
    Rule
    R3
    Definition
    New patient population (to be checked against FDA's list)
    Product numbers
    001, 002
  • NS exclusivity

    exclusivity.txt line 235
    Date
    17 Apr 2028
    Rule
    R3
    Definition
    New strength (to be checked against FDA's list)
    Product numbers
    003
  • PED exclusivity

    exclusivity.txt lines 232, 234, 236
    Date
    17 Oct 2028
    Rule
    R3
    Definition
    Pediatric exclusivity (to be checked against FDA's list)
    Product numbers
    001, 002, 003

Paragraph IV list rows giving NDA 202155

The rows of FDA's Paragraph IV certifications list as captured on 17 October 2026 whose RLD/NDA cell gives NDA 202155, 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 202155

  • Apixaban · Tablets · 2.5 mg and 5 mg

    RLD/NDA as listed: Eliquis 202155
    First PIV submission
    28 Dec 2016
    ANDAs
    25
    180-day status
    Eligible
    Decision posted
    14 Jan 2020
    First applicant approval
    23 Dec 2019
    First marketing
    blank
    Last qualifying patent expiry (as listed by FDA)
    24 Feb 2031

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