RIVAROXABAN | N022406 | JANSSEN PHARMACEUTICALS INC
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2018-01143 | 9539218 | IPR | Mylan Pharmaceuticals Inc. et al. | Institution Denied | 2018-05-24 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
Bayer Intellectual Property GmbH, et al. v. Mankind Pharma Limited 1 patentANDA 220874rivaroxaban | D. Del. | 2025-11-24 | Terminated 2026-01-14 | — |
Bayer Pharma AG, et al. v. Dr. Reddy's Laboratories, Inc. et al. 1 patentANDA 208534rivaroxaban | D. Del. | 2025-08-19 | Terminated 2025-12-10 | — |
| D. Del. | 2025-06-18 | Terminated 2025-12-09 | — | |
Bayer Pharma AG et al v. Macleods Pharmaceuticals Ltd. et al 1 patentANDA 213114rivaroxaban | D. Del. | 2025-06-09 | Terminated 2025-12-11 | — |
| D. Del. | 2025-06-05 | Terminated 2025-12-09 | — | |
| D. Del. | 2025-05-21 | Terminated 2025-12-10 | — | |
| D. Del. | 2025-03-20 | Terminated 2025-12-09 | — | |
| D. Del. | 2024-05-16 | Terminated 2024-11-05 | — | |
| D. Del. | 2024-03-14 | Terminated 2026-01-08 | — | |
| D. Del. | 2024-02-02 | Terminated 2025-12-19 | — | |
| D. Del. | 2023-12-21 | Terminated 2024-03-27 | — | |
| D. Del. | 2023-12-01 | Terminated 2024-05-10 | — | |
| D. Del. | 2023-10-26 | Terminated 2025-12-12 | — | |
| D. Del. | 2023-10-20 | Terminated 2025-12-10 | — | |
Bayer Intellectual Property GmbH et al v. Indoco Remedies Limited et al 2 patentsANDA 218445rivaroxaban | D. Del. | 2023-06-23 | Terminated 2024-02-27 | — |
| D. Del. | 2023-06-16 | Terminated 2024-01-25 | — | |
| D. Del. | 2023-05-19 | Terminated 2026-01-08 | — | |
Mylan Pharmaceuticals Inc. v. Bayer Intellectual Property GMBH et al 2 patentsANDA 212220rivaroxaban | D. Del. | 2023-05-19 | Terminated 2024-03-14 | — |
| D. Del. | 2023-04-13 | Terminated 2025-12-23 | — | |
| D. Del. | 2023-03-24 | Terminated 2023-08-07 | — | |
| D. Del. | 2022-12-14 | Terminated 2025-12-30 | — | |
BAYER INTELLECTUAL PROPERTY GMBH et al v. CHANGZHOU PHARMACEUTICAL FACTORY 1 patentANDA 216995rivaroxaban | D.N.J. | 2022-04-11 | Terminated 2022-06-15 | — |
| D. Del. | 2022-02-04 | Terminated 2022-07-12 | — | |
| D. Del. | 2021-12-10 | Terminated 2026-01-28 | — | |
| D. Del. | 2021-12-10 | Terminated 2025-12-18 | — | |
Bayer Pharma AG et al v. Mylan Pharmaceuticals Inc. et al 1 patentANDA 212220rivaroxaban | N.D. W. Va. | 2021-07-22 | Terminated 2021-12-10 | — |
Bayer Pharma AG et al v. Taro Pharmaceutical Industries Ltd. et al 1 patentANDA 208557rivaroxaban | D. Del. | 2021-07-07 | Terminated 2025-12-12 | — |
| D. Del. | 2021-07-07 | Terminated 2026-01-08 | — | |
Bayer Pharma AG et al v. Dr. Reddys Laboratories, Ltd. et al 1 patentANDA 208534rivaroxaban | D. Del. | 2021-05-24 | Terminated 2025-12-23 | — |
| D. Del. | 2021-04-22 | Terminated 2021-07-29 | — | |
| D. Del. | 2021-03-01 | Terminated 2026-01-28 | — | |
BAYER INTELLECTUAL PROPERTY GMBH et al v. DR. REDDY'S LABORATORIES, LTD. et al 1 patentANDA 208534rivaroxaban | D.N.J. | 2020-08-12 | Terminated 2020-11-04 | — |
BAYER INTELLECTUAL PROPERTY GMBH et al v. UNICHEM INC. et al 2 patentsANDA 214342rivaroxaban | D.N.J. | 2020-05-01 | Terminated 2020-09-03 | — |
| D. Del. | 2019-08-01 | Terminated 2019-12-05 | — | |
| D. Del. | 2019-06-28 | Terminated 2019-12-10 | — | |
| D. Del. | 2019-05-10 | Terminated 2020-09-02 | — | |
| D. Del. | 2018-12-05 | Terminated 2020-09-02 | — | |
Bayer Intellectual Property GmbH et al v. Torrent Pharmaceuticals, Limited et al 1 patentANDA 208556rivaroxaban | D. Del. | 2017-08-18 | Terminated 2020-12-22 | — |
| D. Del. | 2017-08-11 | Terminated 2020-09-02 | — | |
| D. Del. | 2017-07-31 | Terminated 2020-12-22 | — | |
Bayer Intellectual Property GMBH et al v. InvaGen Pharmaceuticals, Inc. 3 patentsANDA 208543rivaroxaban | D. Del. | 2017-06-23 | Terminated 2020-12-22 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consulting Services, Inc. FDA-2026-P-1794 · 8 docket documents Lachman Consulting Services, Inc. filed this suitability petition pursuant to Section 505(j)(2)(C) of the FD&C Act requesting that the FDA declare proposed Rivaroxaban Orally Disintegrating Tablets at 2.5 mg, 10 mg, 15 mg, and 20 mg strengths suitable for submission as an ANDA, referencing XARELTO T | Suitability | 2026-02-18 | Open | Lachman Consulting Services, Inc. |
Suitability Petition from Lachman Consulting Services, Inc. FDA-2025-P-1132 · 8 docket documents Lachman Consulting Services, Inc. filed this suitability petition under Section 505(j)(2)(C) of the FD&C Act requesting that the FDA declare Rivaroxaban Orally Disintegrating Tablets in 2.5 mg, 10 mg, 15 mg, and 20 mg strengths suitable for submission as an ANDA, representing a change in dosage form | Suitability | 2025-05-01 | Open | Lachman Consulting Services, Inc. |
Citizen Petition from Foley & Lardner LLP FDA-2019-P-3022 · 9 docket documents Foley & Lardner LLP filed this citizen petition under 21 CFR § 314.93 and Section 505(j)(2)(C) requesting that the FDA declare rivaroxaban capsules in strengths of 2.5 mg, 10 mg, 15 mg, and 20 mg suitable for submission as an ANDA, with XARELTO (rivaroxaban) tablets of the same strengths as the refe | Other | 2019-06-25 | Denied | Foley & Lardner 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
$19.56
per ea
Lowest NADAC/Unit
$9.78
per ea
Brand NDCs
14
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 50458057910XARELTO 20 MG TABLET | $19.56 | EA | Brand | — | 2026-06-17 |
| 50458057990XARELTO 20 MG TABLET | $19.56 | EA | Brand | — | 2026-06-17 |
| 50458057989XARELTO 20 MG TABLET | $19.56 | EA | Brand | — | 2026-06-17 |
| 50458057930XARELTO 20 MG TABLET | $19.56 | EA | Brand | — | 2026-06-17 |
| 50458057810XARELTO 15 MG TABLET | $19.53 | EA | Brand | — | 2026-06-17 |
| 50458057830XARELTO 15 MG TABLET | $19.53 | EA | Brand | — | 2026-06-17 |
Showing 6 of 14 NDCs.
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9539218 | Feb 17, 2034PED: Aug 17, 2034 | PED | — | — | — |