LENALIDOMIDE | N021880 | BRISTOL MYERS SQUIBB
| Trial # | Patent | Type | Petitioner | Status | Filed | Decision |
|---|---|---|---|---|---|---|
| IPR2018-00685 | 8741929 | IPR | Apotex Inc. et al. | Institution Denied | 2018-02-23 | — |
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D.N.J. | 2022-06-13 | Terminated 2022-10-14 | — | |
CELGENE CORPORATION v. ONCOGEN PHARMA (MALAYSIA) SDN. BHD. 7 patentsANDA 217281lenalidomide | D.N.J. | 2022-05-20 | Terminated 2022-05-25 | — |
| D.N.J. | 2021-11-18 | Terminated 2022-07-05 | — | |
| D.N.J. | 2020-07-09 | Terminated 2021-12-14 | — | |
| D.N.J. | 2020-01-08 | Terminated 2021-07-19 | — | |
Celgene Corporation v. Mylan Pharmaceuticals Inc. et al 10 patentsANDA 213912lenalidomide | WVND | 2020-01-03 | Terminated 2021-07-23 | — |
CELGENE CORPORATION v. MYLAN PHARMACEUTICALS INC. et al 10 patentsANDA 213912lenalidomide | D.N.J. | 2019-12-31 | Terminated 2021-07-22 | — |
| D.N.J. | 2019-07-16 | Terminated 2021-01-11 | — | |
CELGENE CORPORATION v. SUN PHARMACEUTICAL INDUSTRIES, INC. et al 3 patentsANDA 211846lenalidomide | D.N.J. | 2019-04-16 | Terminated 2021-06-22 | — |
| D.N.J. | 2018-12-20 | Terminated 2021-01-11 | — | |
| D.N.J. | 2010-10-08 | Terminated 2016-01-05 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Lachman Consultant Services, Inc. FDA-2026-P-7177 Lachman Consultant Services, Inc. submitted a suitability petition under section 505(j)(2)(C) of the Federal Food, Drug, and Cosmetic Act requesting FDA approval to pursue an Abbreviated New Drug Application for Lenalidomide Oral Solution 5 mg/mL, which differs from the Reference Listed Drug REVLIMI | Suitability | 2026-06-29 | Open | Lachman Consultant Services |
Source: Regulations.gov. FDA citizen petitions matched by application number.