FIRDAPSE — FDA application NDA208078
Listed sponsor: CATALYST PHARMS · CPRX 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 | FIRDAPSE | AMIFAMPRIDINE PHOSPHATE | TABLET | ORAL | EQ 10MG 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 11060128 | 001 | listed patent expiry date: 2032-06-29 | U-2956 |
| Patent 11268128 | 001 | listed patent expiry date: 2032-06-29 | U-2956 |
| Patent 11274331 | 001 | listed patent expiry date: 2032-06-29 | U-2956 |
| Patent 11274332 | 001 | listed patent expiry date: 2032-06-29 | U-2956 |
| Patent 10793893 | 001 | listed patent expiry date: 2034-05-26 | U-2956 |
| Patent 10626088 | 001 | listed patent expiry date: 2037-02-25 | drug product |
| Exclusivity ODE-553 | 001 | listed exclusivity date: 2029-09-29 | FDA code as listed |
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 · CHEMBL3301611
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.