AMANTADINE HYDROCHLORIDE | N208944 | SUPERNUS PHARMACEUTICALS INC
| Case | Court | Filed | Status | Judge |
|---|---|---|---|---|
ADAMAS PHARMA, LLC v. ZYDUS WORLDWIDE DMCC et al 15 patentsANDA 214897amantadine hydrochloride | D.N.J. | 2020-08-13 | Terminated 2021-02-03 | — |
| D.N.J. | 2018-05-10 | Terminated 2020-01-06 | — | |
Osmotica Pharmaceutical US LLC et al v. Adamas Pharmaceuticals, Inc. et al 14 patentsANDA 075060amantadine hydrochloride | D. Del. | 2018-02-16 | Terminated 2021-01-07 | — |
Source: PACER. NOS 835 (Patent - Abbreviated New Drug Application).
| Petition | Type | Filed | Status | Petitioner |
|---|---|---|---|---|
Suitability Petition from Buchanan Ingersoll & Rooney PC FDA-2025-P-6646 Buchanan Ingersoll & Rooney PC filed this suitability petition under section 505(j)(2)(C) of the Federal Food, Drug and Cosmetic Act requesting that the FDA determine Amantadine Extended-Release Capsules, 274 mg, is suitable for submission as an ANDA, with GOCOVRI (amantadine) Extended-Release Capsu | Suitability | 2025-12-02 | Open | Buchanan Ingersoll & Rooney PC |
Source: Regulations.gov. FDA citizen petitions matched by application number.
| Patent # | Expiration | PED | Drug Substance | Drug Product | Use Code | Delist |
|---|---|---|---|---|---|---|
| 8389578 | Jan 22, 2028 | — | — | — | — | |
| 8741343 | Dec 2, 2030 | — | — | — | — | |
| 9867791 | Dec 2, 2030 | — | — | — | — | |
| 9867792 | Dec 2, 2030 | — | — | — | — | |
| 9867793 | Dec 2, 2030 | — | — | — | — | |
| 9877933 | Dec 2, 2030 | — | — | — | — | |
| 10154971 | Dec 4, 2034 | — | — | — | — | |
| 10646456 | Jun 17, 2034 | — | — | — | — | |
| 11065213 | Aug 23, 2038 | — | — | Yes | — | — |
| 11077073 | Aug 23, 2038 | — | — | — | — | |
| 11197835 | Dec 2, 2030 | — | — | — | — | |
| 11903908 | Jun 17, 2034 | — | — | — | — | |
| 12233033 | Aug 23, 2038 | — | — | — | — |