# FIRDAPSE — FDA application NDA208078

Informational only - not investment advice.

Application NDA208078 · type NDA · FDA status: approved · original approval 2018-11-28

Listed sponsor: CATALYST PHARMS · [CPRX company profile](/company/CPRX/) · 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 | FIRDAPSE | AMIFAMPRIDINE PHOSPHATE | TABLET | ORAL | EQ 10MG BASE | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 11060128, product 001; listed patent expiry date: 2032-06-29.
- Patent 11268128, product 001; listed patent expiry date: 2032-06-29.
- Patent 11274331, product 001; listed patent expiry date: 2032-06-29.
- Patent 11274332, product 001; listed patent expiry date: 2032-06-29.
- Patent 10793893, product 001; listed patent expiry date: 2034-05-26.
- Patent 10626088, product 001; listed patent expiry date: 2037-02-25.
- Exclusivity ODE-553, product 001; listed exclusivity date: 2029-09-29.

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

- AMIFAMPRIDINE PHOSPHATE · UNII 8HF8FIN815 · [lmmol compound KAICRBBQCRKMPO-UHFFFAOYSA-N](https://lmmol.com/compound/KAICRBBQCRKMPO-UHFFFAOYSA-N)

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/CPRX/)
- [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:NDA208078. FDA data retrieved 2026-08-07.

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