# GOCOVRI — FDA application NDA208944

Informational only - not investment advice.

Application NDA208944 · type NDA · FDA status: approved · original approval 2017-08-24

Listed sponsor: SUPERNUS PHARMS · [SUPN company profile](/company/SUPN/) · 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 |

## Orange Book patent and exclusivity listings

- Patent 8389578, product 001; listed patent expiry date: 2028-01-22.
- Patent 8389578, product 002; listed patent expiry date: 2028-01-22.
- Patent 11197835, product 001; listed patent expiry date: 2030-12-02.
- Patent 11197835, product 002; listed patent expiry date: 2030-12-02.
- Patent 8741343, product 001; listed patent expiry date: 2030-12-02.
- Patent 8741343, product 002; listed patent expiry date: 2030-12-02.
- Patent 9867791, product 001; listed patent expiry date: 2030-12-02.
- Patent 9867791, product 002; listed patent expiry date: 2030-12-02.
- Patent 9867792, product 001; listed patent expiry date: 2030-12-02.
- Patent 9867792, product 002; listed patent expiry date: 2030-12-02.
- Patent 9867793, product 001; listed patent expiry date: 2030-12-02.
- Patent 9867793, product 002; listed patent expiry date: 2030-12-02.
- Patent 9877933, product 001; listed patent expiry date: 2030-12-02.
- Patent 9877933, product 002; listed patent expiry date: 2030-12-02.
- Patent 10646456, product 001; listed patent expiry date: 2034-06-17.
- Patent 10646456, product 002; listed patent expiry date: 2034-06-17.
- Patent 11903908, product 001; listed patent expiry date: 2034-06-17.
- Patent 11903908, product 002; listed patent expiry date: 2034-06-17.
- Patent 10154971, product 001; listed patent expiry date: 2034-12-04.
- Patent 10154971, product 002; listed patent expiry date: 2034-12-04.
- Patent 11065213, product 001; listed patent expiry date: 2038-08-23.
- Patent 11065213, product 002; listed patent expiry date: 2038-08-23.
- Patent 11077073, product 001; listed patent expiry date: 2038-08-23.
- Patent 11077073, product 001; listed patent expiry date: 2038-08-23.
- Patent 11077073, product 001; listed patent expiry date: 2038-08-23.
- Patent 11077073, product 002; listed patent expiry date: 2038-08-23.
- Patent 11077073, product 002; listed patent expiry date: 2038-08-23.
- Patent 11077073, product 002; listed patent expiry date: 2038-08-23.
- Patent 12233033, product 001; listed patent expiry date: 2038-08-23.
- Patent 12233033, product 001; listed patent expiry date: 2038-08-23.
- Patent 12233033, product 001; listed patent expiry date: 2038-08-23.
- Patent 12233033, product 002; listed patent expiry date: 2038-08-23.
- Patent 12233033, product 002; listed patent expiry date: 2038-08-23.
- Patent 12233033, product 002; listed patent expiry date: 2038-08-23.

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](/company/SUPN/)
- [FDA-approved application index](/drug/)

Sources: https://www.fda.gov/drugs/drug-approvals-and-databases/drugsfda-data-files · https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files · https://api.fda.gov/drug/drugsfda.json?search=application_number:NDA208944. FDA data retrieved 2026-08-07.

Regulatory listing data as published by FDA; not medical or investment advice.