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. | 2023-12-01 | Terminated 2024-05-10 | — | |
Bayer Intellectual Property GmbH et al v. Indoco Remedies Limited et al 2 patentsANDA 218445rivaroxaban | D. Del. | 2023-06-23 | Terminated 2024-02-27 | — |
Mylan Pharmaceuticals Inc. v. Bayer Intellectual Property GMBH et al 2 patentsANDA 212220rivaroxaban | D. Del. | 2023-05-19 | Terminated 2024-03-14 | — |
| 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 | — | |
Bayer Pharma AG et al v. Mylan Pharmaceuticals Inc. et al 1 patentANDA 212220rivaroxaban | WVND | 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. | 2021-03-01 | 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 | — |
Bayer Intellectual Property GmbH et al v. Torrent Pharmaceuticals, Limited et al 1 patentANDA 208556rivaroxaban | D. Del. | 2017-08-18 | 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 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 |
Suitability Petition from Lachman Consulting Services, Inc. FDA-2025-P-1132 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 |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 9539218 | Feb 17, 2034PED: Aug 17, 2034 | PED | — | — | — |