ESLICARBAZEPINE ACETATE | N022416 | SUMITOMO PHARMA AMERICA INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
| D. Del. | 2021-11-29 | Terminated 2022-11-14 | — | |
| D. Del. | 2021-02-10 | Terminated 2022-05-05 | — | |
| D. Del. | 2021-02-10 | Terminated 2022-10-24 | — | |
| D. Del. | 2021-02-10 | Terminated 2021-12-08 | — | |
| D. Del. | 2021-02-10 | Terminated 2022-03-04 | — | |
| D. Del. | 2021-02-10 | Terminated 2021-11-18 | — | |
| D. Del. | 2020-06-09 | Terminated 2020-07-29 | — | |
| D. Del. | 2020-06-09 | Terminated 2022-10-24 | — | |
| D. Del. | 2020-06-09 | Terminated 2020-12-29 | — | |
| D. Del. | 2020-06-09 | Terminated 2022-03-04 | — | |
| D. Del. | 2020-06-09 | Terminated 2022-05-05 | — | |
| D. Del. | 2020-06-09 | Terminated 2021-12-08 | — | |
| D. Del. | 2020-06-09 | Terminated 2021-11-18 | — | |
| D. Del. | 2019-09-06 | Terminated 2021-11-18 | — | |
| D. Del. | 2018-05-21 | Terminated 2020-05-27 | — | |
| D. Del. | 2018-03-09 | Terminated 2022-05-05 | — | |
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 | — |
| D. Del. | 2018-03-02 | Terminated 2020-07-29 | — | |
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 | — |
| D. Del. | 2018-02-16 | Terminated 2021-11-18 | — |
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 · 11 docket documents 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 | Partially Denied | Humanwell Pharmaceutical US, Inc. |
Source: Regulations.gov. FDA citizen petitions matched by application number.
Highest NADAC/Unit
$44.40
per ea
Lowest NADAC/Unit
$44.24
per ea
Brand NDCs
4
Generic NDCs
0
| NDC Description | NADAC/Unit | Unit | Type | Generic NADAC | Effective |
|---|---|---|---|---|---|
| 63402020660APTIOM 600 MG TABLET | $44.40 | EA | Brand | $2.95 | 2026-06-17 |
| 63402020430APTIOM 400 MG TABLET | $44.35 | EA | Brand | $2.93 | 2026-06-17 |
| 63402020830APTIOM 800 MG TABLET | $44.25 | EA | Brand | $2.65 | 2026-06-17 |
| 63402020230APTIOM 200 MG TABLET | $44.24 | EA | Brand | $2.06 | 2026-01-01 |
Source: NADAC (data.medicaid.gov). Prices reflect national average acquisition costs for retail community pharmacies.