ESLICARBAZEPINE ACETATE | N022416 | SUMITOMO PHARMA AMERICA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
BIAL - PORTELA & CA S.A. et al v. Dr. Reddy's Laboratories, Ltd. et al 6 patentsANDA 211238Eslicarbazepine Acetate | D. Del. | 2018-03-02 | Terminated 2021-12-08 | — |
BIAL - PORTELA & CA S.A. et al v. Jubilant Life Sciences Limited et al 6 patentsANDA 211219eslicarbazepine acetate | D. Del. | 2018-03-01 | Terminated 2022-03-04 | — |
Bial - Portela & CA S.A., et al v. Lupin Limited, et al 6 patentsANDA 211246eslicarbazepine acetate | D. Del. | 2018-02-23 | Terminated 2020-12-29 | — |
BIAL - PORTELA & CA S.A. et al v. Alkem Laboratories Limited 6 patentsANDA 211199Eslicarbazepine Acetate | D. Del. | 2018-02-22 | Terminated 2022-10-24 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Epic Pharma, LLC (on behalf of Humanwell Pharmaceut... FDA-2024-P-3090 Epic Pharma, LLC, on behalf of Humanwell Pharmaceutical US, Inc., filed a suitability petition under Section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting FDA approval to submit an ANDA for Eslicarbazepine Acetate Oral Suspension at 50 mg/mL, a new dosage form and strength diffe | Suitability | 2024-07-01 | Open | Epic Pharma |
Source: Regulations.gov. FDA citizen petitions matched by application number.