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 | — | |
Bristol-Myers Squibb Company et al v. ScieGen Pharmaceuticals, Inc. 1 patentANDA 218119apixaban | D. Del. | 2023-04-06 | Terminated 2023-04-27 | — |
| D. Del. | 2017-04-10 | Terminated 2019-05-07 | — | |
Bristol-Myers Squibb Company et al v. Aurobindo Pharma USA Inc. 2 patentsANDA 210026apixaban | D. Del. | 2017-04-05 | Terminated 2020-08-13 | — |
Bristol-Myers Squibb Company et al v. InvaGen Pharmaceuticals, Inc. 1 patentANDA 209984apixaban | D. Del. | 2017-04-05 | Terminated 2018-09-24 | — |
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 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 bein | Suitability | 2026-05-04 | Open | Unison Pharmaceuticals Pvt. Ltd. |
Suitability Petition from Hyman, Phelps & McNamara, P.C. FDA-2026-P-0126 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 |
Suitability Petition from Lachman Consulting Services, Inc. FDA-2024-P-4890 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 | Open | Lachman Consulting Services |
Suitability Petition from Lupin, Inc. FDA-2024-P-0526 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 | Open | Lupin |
Attachment 3, SUPPLEMENT TO ANDA - Proposed Prescribing Information for Apix... FDA-2016-P-3463 Axinn, Veltrop & Harkrider LLP filed a suitability petition regarding proposed prescribing information for apixaban tablets as a supplement to an Abbreviated New Drug Application, seeking FDA review and approval of the proposed labeling for this generic anticoagulant product. | Suitability | 2016-10-25 | Open | Axinn |
Suitability Petition from Axinn, Veltrop & Harkrider LLP FDA-2016-P-3463 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 | Open | Axinn |
Attachment 3 Proposed Prescribing Information for Apixaban Tablets re Suitabi... FDA-2016-P-3463 I cannot provide a summary of this FDA citizen petition based on the information provided. The document excerpt contains only a title and header indicating this is proposed prescribing information for apixaban tablets related to a suitability petition filed by the law firm Axinn, Veltrop & Harkrider | Suitability | 2016-10-21 | Open | Axinn |
Attachment 1 FDA Orange Book page for Eliquis® (apixaban) tablets, 2.5 mg and... FDA-2016-P-3463 The law firm Axinn, Veltrop & Harkrider LLP filed a petition regarding Eliquis (apixaban) tablets in 2.5 mg and 5 mg strengths, requesting determination of suitability for abbreviated new drug application (ANDA) approval based on the Orange Book listing for this anticoagulant product. | Suitability | 2016-10-21 | Open | Axinn |
Attachment 2 Copy of approved labeling for Eliquis® (apixaban) tablets (NDA 2... FDA-2016-P-3463 This document is an attachment containing approved labeling for Eliquis (apixaban) tablets under NDA 202155 held by Bristol Myers Squibb, submitted in connection with a suitability petition filed by the law firm Axinn, Veltrop & Harkrider LLP. The attachment itself consists of the product labeling a | Suitability | 2016-10-21 | Open | Axinn |
Source: Regulations.gov. FDA citizen petitions matched by application number.