GOCOVRI — FDA application NDA208944
Listed sponsor: SUPERNUS PHARMS · SUPN company profile · exact_unique
Sponsor as listed in Drugs@FDA at retrieval (2026-08-07); FDA sponsor listings can lag ownership transfers.
FDA application facts
| Product | FDA-listed trade name | Active ingredient | Dosage form | Route | Strength | Marketing status | TE code | RLD |
|---|---|---|---|---|---|---|---|---|
| 001 | GOCOVRI | AMANTADINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | EQ 68.5MG BASE | Prescription | not listed | Yes |
| 002 | GOCOVRI | AMANTADINE HYDROCHLORIDE | CAPSULE, EXTENDED RELEASE | ORAL | EQ 137MG BASE | Prescription | not listed | Yes |
Product, form, strength, reference-drug and marketing-status fields: Drugs@FDA data files; TE and RLD fields: Orange Book data files. Retrieved 2026-08-07.
Orange Book patent and exclusivity listings
| Listing | Product | Descriptive date | Flags/code |
|---|---|---|---|
| Patent 8389578 | 001 | listed patent expiry date: 2028-01-22 | U-2105 |
| Patent 8389578 | 002 | listed patent expiry date: 2028-01-22 | U-2105 |
| Patent 11197835 | 001 | listed patent expiry date: 2030-12-02 | U-2106 |
| Patent 11197835 | 002 | listed patent expiry date: 2030-12-02 | U-2106 |
| Patent 8741343 | 001 | listed patent expiry date: 2030-12-02 | U-2106 |
| Patent 8741343 | 002 | listed patent expiry date: 2030-12-02 | U-2106 |
| Patent 9867791 | 001 | listed patent expiry date: 2030-12-02 | U-2106 |
| Patent 9867791 | 002 | listed patent expiry date: 2030-12-02 | U-2106 |
| Patent 9867792 | 001 | listed patent expiry date: 2030-12-02 | U-2106 |
| Patent 9867792 | 002 | listed patent expiry date: 2030-12-02 | U-2106 |
| Patent 9867793 | 001 | listed patent expiry date: 2030-12-02 | U-2106 |
| Patent 9867793 | 002 | listed patent expiry date: 2030-12-02 | U-2106 |
| Patent 9877933 | 001 | listed patent expiry date: 2030-12-02 | U-2224 |
| Patent 9877933 | 002 | listed patent expiry date: 2030-12-02 | U-2224 |
| Patent 10646456 | 001 | listed patent expiry date: 2034-06-17 | U-2808 |
| Patent 10646456 | 002 | listed patent expiry date: 2034-06-17 | U-2808 |
| Patent 11903908 | 001 | listed patent expiry date: 2034-06-17 | U-3822 |
| Patent 11903908 | 002 | listed patent expiry date: 2034-06-17 | U-3822 |
| Patent 10154971 | 001 | listed patent expiry date: 2034-12-04 | U-2459 |
| Patent 10154971 | 002 | listed patent expiry date: 2034-12-04 | U-2459 |
| Patent 11065213 | 001 | listed patent expiry date: 2038-08-23 | drug product |
| Patent 11065213 | 002 | listed patent expiry date: 2038-08-23 | drug product |
| Patent 11077073 | 001 | listed patent expiry date: 2038-08-23 | U-2106 |
| Patent 11077073 | 001 | listed patent expiry date: 2038-08-23 | U-2224 |
| Patent 11077073 | 001 | listed patent expiry date: 2038-08-23 | U-3180 |
| Patent 11077073 | 002 | listed patent expiry date: 2038-08-23 | U-2224 |
| Patent 11077073 | 002 | listed patent expiry date: 2038-08-23 | U-3180 |
| Patent 11077073 | 002 | listed patent expiry date: 2038-08-23 | U-2106 |
| Patent 12233033 | 001 | listed patent expiry date: 2038-08-23 | U-2106 |
| Patent 12233033 | 001 | listed patent expiry date: 2038-08-23 | U-3180 |
| Patent 12233033 | 001 | listed patent expiry date: 2038-08-23 | U-2224 |
| Patent 12233033 | 002 | listed patent expiry date: 2038-08-23 | U-2224 |
| Patent 12233033 | 002 | listed patent expiry date: 2038-08-23 | U-2106 |
| Patent 12233033 | 002 | listed patent expiry date: 2038-08-23 | U-3180 |
Patent and exclusivity dates are regulatory listings from the FDA Orange Book; no relationship to revenue or future sales is stated or implied.
Compound cross-links
- AMANTADINE · UNII BF4C9Z1J53 · no lmmol compound match
Ingredient–compound links use FDA openFDA/GSRS identifiers and an exact lmmol InChIKey join. Ingredient names cannot create a link.
Related pages
Sponsor company · FDA-approved application index
Peer clusters: No published peer-cluster link for this sponsor.
Sources: Drugs@FDA · Orange Book · openFDA application record. FDA data retrieved 2026-08-07.
Regulatory listing data as published by FDA; not medical or investment advice.