APIXABAN | N202155 | BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2015-01723 | 6967208 | IPR | Coalition for Affordable Drugs IX, LLC et al. | Institution Denied | 2015-08-13 | — |
| IPR2018-00892 | 9326945 | IPR | Mylan Pharmaceuticals Inc. | Terminated-Settled | 2018-04-05 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2025-12-23 | Active | — | |
| D. Del. | 2024-09-30 | Terminated 2024-10-15 | — | |
| D. Del. | 2023-04-06 | Terminated 2023-06-21 | — | |
Bristol-Myers Squibb Company et al v. ScieGen Pharmaceuticals, Inc. 1 patentANDA 218119apixaban | D. Del. | 2023-04-06 | Terminated 2023-04-27 | — |
| D. Del. | 2019-01-09 | Terminated 2020-08-13 | — | |
| D. Del. | 2018-01-19 | Terminated 2018-08-06 | — | |
| D. Del. | 2017-04-13 | Terminated 2018-04-05 | — | |
| N.D. W. Va. | 2017-04-12 | Terminated 2018-12-26 | — | |
| D. Del. | 2017-04-10 | Terminated 2018-07-02 | — | |
| D. Del. | 2017-04-10 | Terminated 2019-05-07 | — | |
| D. Del. | 2017-04-10 | Terminated 2019-11-04 | — | |
| D. Del. | 2017-04-10 | Terminated 2018-01-16 | — | |
| D. Del. | 2017-04-10 | Terminated 2018-12-11 | — | |
| D. Del. | 2017-04-10 | Terminated 2018-05-15 | — | |
| D. Del. | 2017-04-10 | Terminated 2017-11-07 | — | |
| D. Del. | 2017-04-10 | Terminated 2018-01-10 | — | |
| D. Del. | 2017-04-10 | Terminated 2018-01-29 | — | |
| D. Del. | 2017-04-10 | Terminated 2020-08-13 | — | |
| D. Del. | 2017-04-10 | Terminated 2018-01-16 | — | |
| D. Del. | 2017-04-10 | Terminated 2017-09-08 | — | |
| D. Del. | 2017-04-10 | Terminated 2018-01-22 | — | |
| D. Del. | 2017-04-10 | Terminated 2018-03-09 | — | |
| D. Del. | 2017-04-10 | Terminated 2019-07-02 | — | |
| D. Del. | 2017-04-05 | Terminated 2020-08-13 | — | |
| D. Del. | 2017-04-05 | Terminated 2017-12-04 | — | |
| D. Del. | 2017-04-05 | Terminated 2018-11-14 | — | |
| D. Del. | 2017-04-05 | Terminated 2017-10-25 | — | |
| D. Del. | 2017-04-05 | Terminated 2017-12-21 | — | |
Bristol-Myers Squibb Company et al v. Aurobindo Pharma USA Inc. 2 patentsANDA 210026apixaban | D. Del. | 2017-04-05 | Terminated 2020-08-13 | — |
| D. Del. | 2017-04-05 | Terminated 2018-05-09 | — | |
Bristol-Myers Squibb Company et al v. InvaGen Pharmaceuticals, Inc. 1 patentANDA 209984apixaban | D. Del. | 2017-04-05 | Terminated 2018-09-24 | — |
| D. Del. | 2017-04-05 | Terminated 2020-08-13 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Unison Pharmaceuticals Pvt. Ltd. FDA-2026-P-4800 · 11 docket documents Unison Pharmaceuticals Pvt. Ltd. filed this suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Apixaban Orally Disintegrating Tablets 2.5 mg and 5 mg suitable for submission as an ANDA, with the reference listed drug being | Suitability | 2026-05-04 | Open | Unison Pharmaceuticals Pvt. Ltd. |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-0126 · 7 docket documents Hyman, Phelps & McNamara, P.C., on behalf of a client, filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Apixaban Tablets for Oral Suspension, 2.5 mg, suitable for submission in an Abbreviated New Drug Application, with | Suitability | 2026-01-06 | Open | Hyman, Phelps & McNamara, P.C. |
Suitability Petition from Lachman Consulting Services, Inc. FDA-2024-P-4890 · 9 docket documents Lachman Consulting Services, Inc. filed this suitability petition on behalf of a client requesting that the FDA declare Apixaban Oral Suspension, 1.25 mg/mL suitable for submission as an ANDA under section 505(j)(2)(C) of the FD&C Act, with the reference drug being ELIQUIS tablets (2.5 mg and 5 mg) | Suitability | 2024-10-21 | Denied | Lachman Consulting Services, Inc. |
Suitability Petition from Lupin, Inc. FDA-2024-P-0526 · 10 docket documents Lupin, Inc. submitted a suitability petition pursuant to Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA declare Apixaban Oral Suspension, 1.25 mg/mL suitable for consideration in an ANDA, with the reference drug product being ELIQUIS (apixaban) Tablets by Bri | Suitability | 2024-01-26 | Denied | Lupin, Inc. |
Citizen Petition from Axinn, Veltrop & Harkrider LLP FDA-2017-P-6020 · 6 docket documents The law firm Axinn, Veltrop & Harkrider LLP filed this suitability petition on October 3, 2017, requesting that the FDA declare Apixaban Tablets, 10 mg, suitable for submission in an ANDA under Section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act, with the reference listed drug being Eli | Other | 2017-10-04 | Denied | Axinn, Veltrop & Harkrider LLP |
Suitability Petition from Axinn, Veltrop & Harkrider LLP FDA-2016-P-3463 · 7 docket documents Axinn, Veltrop & Harkrider LLP filed this ANDA suitability petition on behalf of a client pursuant to Section 505(j)(2)(c) of the Federal Food, Drug and Cosmetic Act, requesting that the FDA declare Apixaban Tablets, 10 mg, suitable for submission in an ANDA with Eliquis (apixaban) Tablets, 2.5 mg a | Suitability | 2016-10-21 | Withdrawn | Axinn, Veltrop & Harkrider LLP |
Citizen Petition from David Cundiff FDA-2015-P-3408 · 5 docket documents David Cundiff filed this citizen petition under 21 U.S.C. Section 355(e)(3) and 21 C.F.R. 10.30 requesting that the FDA designate all anticoagulants including heparin, low molecular weight heparins, fondaparinux, warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban as contraindicated for patien | Other | 2015-10-26 | Denied | David Cundiff |
Citizen Petition from David K Cundiff FDA-2015-P-3410 · 4 docket documents David K. Cundiff filed this petition under the Federal Food, Drug, and Cosmetic Act section 355(e)(3) on September 25, 2015, requesting that the FDA withdraw approval and designate all oral anticoagulants including warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban as contraindicated for non- | Other | 2015-10-07 | Denied | David K Cundiff |
Citizen Petition from David K. Cundiff, MD FDA-2015-P-2373 · 4 docket documents David K. Cundiff, MD filed this petition under 21 U.S.C. Section 355(e)(3) requesting that the FDA revoke approval and add contraindication labels for all anticoagulant drugs including heparin, warfarin, dabigatran, rivaroxaban, apixaban, and edoxaban for the treatment of venous thromboembolism (dee | Other | 2015-07-14 | Denied | David K. Cundiff, MD |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$5.52
per ea
Lowest NADAC/Unit
$5.51
per ea
Brand NDCs
6
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 00003089421ELIQUIS 5 MG TABLET | $5.52 | EA | Brand | — | 2026-06-17 |
| 00003089431ELIQUIS 5 MG TABLET | $5.52 | EA | Brand | — | 2026-06-17 |
| 00003089470ELIQUIS 5 MG TABLET | $5.52 | EA | Brand | — | 2026-06-17 |
| 00003089321ELIQUIS 2.5 MG TABLET | $5.52 | EA | Brand | — | 2026-06-17 |
| 00003089331ELIQUIS 2.5 MG TABLET | $5.52 | EA | Brand | — | 2026-06-17 |
| 00003376474ELIQUIS DVT-PE TREATMENT 30-DAY STARTER 5 MG PACK | $5.51 | EA | Brand | — | 2026-06-17 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.