# FYCOMPA — FDA application NDA202834

Informational only - not investment advice.

Application NDA202834 · type NDA · FDA status: approved · original approval 2012-10-22

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 | FYCOMPA | PERAMPANEL | TABLET | ORAL | 2MG | Prescription | AB | Yes |
| 002 | FYCOMPA | PERAMPANEL | TABLET | ORAL | 4MG | Prescription | AB | Yes |
| 003 | FYCOMPA | PERAMPANEL | TABLET | ORAL | 6MG | Prescription | AB | Yes |
| 004 | FYCOMPA | PERAMPANEL | TABLET | ORAL | 8MG | Prescription | AB | Yes |
| 005 | FYCOMPA | PERAMPANEL | TABLET | ORAL | 10MG | Prescription | AB | Yes |
| 006 | FYCOMPA | PERAMPANEL | TABLET | ORAL | 12MG | Prescription | AB | Yes |

## Orange Book patent and exclusivity listings

- Patent 8772497, product 001; listed patent expiry date: 2026-07-01.
- Patent 8772497, product 002; listed patent expiry date: 2026-07-01.
- Patent 8772497, product 003; listed patent expiry date: 2026-07-01.
- Patent 8772497, product 004; listed patent expiry date: 2026-07-01.
- Patent 8772497, product 005; listed patent expiry date: 2026-07-01.
- Patent 8772497, product 006; listed patent expiry date: 2026-07-01.

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

- PERAMPANEL · UNII H821664NPK · [lmmol compound PRMWGUBFXWROHD-UHFFFAOYSA-N](https://lmmol.com/compound/PRMWGUBFXWROHD-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:NDA202834. FDA data retrieved 2026-08-07.

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