grepcent public filings, reorganized for comparison

AGAMREE — FDA application NDA215239

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

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

ProductFDA-listed trade nameActive ingredientDosage formRouteStrengthMarketing statusTE codeRLD
001AGAMREEVAMOROLONESUSPENSIONORAL40MG/MLPrescriptionnot listedYes

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

ListingProductDescriptive dateFlags/code
Patent 10857161001listed patent expiry date: 2029-05-28drug product, U-3747
Patent 11833159001listed patent expiry date: 2029-05-28drug product
Patent 8334279001listed patent expiry date: 2029-05-28U-3747
Patent 11690853001listed patent expiry date: 2033-03-07U-3747
Patent 11471471001listed patent expiry date: 2040-03-17U-3747
Patent 12201639001listed patent expiry date: 2040-03-17drug substance, drug product, U-3747
Patent 11382922001listed patent expiry date: 2040-07-16drug substance, drug product
Exclusivity NCE001listed exclusivity date: 2028-10-26FDA code as listed
Exclusivity ODE-450001listed exclusivity date: 2030-10-26FDA code as listed
NDA215239 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA215239 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA215239 FDA listing datesDescriptive regulatory dates only; no relationship to revenue or future sales is stated or implied.Source: Drugs@FDA and FDA Orange Book.Listed dateDated listing marker0.001.002.002023-10-261.002028-10-261.002029-05-281.002030-10-261.002033-03-071.002040-03-171.002040-07-161.00

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

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.