grepcent public filings, reorganized for comparison

AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) — FDA application NDA219616

Application NDA219616 · type NDA · FDA status: approved · original approval 2025-05-08

Listed sponsor: VERASTEM INC · VSTM 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
001AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDECAPSULE, TABLETORALEQ 0.8MG BASE;EQ 200MG BASEPrescriptionnot 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 7897792001listed patent expiry date: 2027-02-09drug substance, drug product
Patent 8247411001listed patent expiry date: 2028-04-17drug substance, drug product
Patent 7928109001listed patent expiry date: 2029-08-21drug substance, drug product
Patent 11400090001listed patent expiry date: 2038-10-29U-4196
Patent 11517573001listed patent expiry date: 2040-09-11U-4196
Patent 11517573001listed patent expiry date: 2040-09-11U-4205
Patent 11873296001listed patent expiry date: 2042-12-29drug product, U-4196
Patent 12509450001listed patent expiry date: 2042-12-29drug product
Exclusivity NCE001listed exclusivity date: 2030-05-08FDA code as listed
Exclusivity ODE-525001listed exclusivity date: 2032-05-08FDA code as listed
NDA219616 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA219616 FDA listing dates. Source: Drugs@FDA and FDA Orange Book.NDA219616 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 marker0.001.002.002025-05-081.002027-02-091.002028-04-171.002029-08-211.002030-05-081.002032-05-081.002038-10-291.002040-09-111.002042-12-291.00

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.