# AGAMREE — FDA application NDA215239

Informational only - not investment advice.

Application NDA215239 · type NDA · FDA status: approved · original approval 2023-10-26

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 | AGAMREE | VAMOROLONE | SUSPENSION | ORAL | 40MG/ML | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 10857161, product 001; listed patent expiry date: 2029-05-28.
- Patent 11833159, product 001; listed patent expiry date: 2029-05-28.
- Patent 8334279, product 001; listed patent expiry date: 2029-05-28.
- Patent 11690853, product 001; listed patent expiry date: 2033-03-07.
- Patent 11471471, product 001; listed patent expiry date: 2040-03-17.
- Patent 12201639, product 001; listed patent expiry date: 2040-03-17.
- Patent 11382922, product 001; listed patent expiry date: 2040-07-16.
- Exclusivity NCE, product 001; listed exclusivity date: 2028-10-26.
- Exclusivity ODE-450, product 001; listed exclusivity date: 2030-10-26.

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

- VAMOROLONE · UNII not resolved · 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/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:NDA215239. FDA data retrieved 2026-08-07.

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