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

Informational only - not investment advice.

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

Listed sponsor: VERASTEM INC · [VSTM company profile](/company/VSTM/) · 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 | AVMAPKI FAKZYNJA CO-PACK (COPACKAGED) | AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE | CAPSULE, TABLET | ORAL | EQ 0.8MG BASE;EQ 200MG BASE | Prescription | not listed | Yes |

## Orange Book patent and exclusivity listings

- Patent 7897792, product 001; listed patent expiry date: 2027-02-09.
- Patent 8247411, product 001; listed patent expiry date: 2028-04-17.
- Patent 7928109, product 001; listed patent expiry date: 2029-08-21.
- Patent 11400090, product 001; listed patent expiry date: 2038-10-29.
- Patent 11517573, product 001; listed patent expiry date: 2040-09-11.
- Patent 11517573, product 001; listed patent expiry date: 2040-09-11.
- Patent 11873296, product 001; listed patent expiry date: 2042-12-29.
- Patent 12509450, product 001; listed patent expiry date: 2042-12-29.
- Exclusivity NCE, product 001; listed exclusivity date: 2030-05-08.
- Exclusivity ODE-525, product 001; listed exclusivity date: 2032-05-08.

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

- AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE · 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/VSTM/)
- [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:NDA219616. FDA data retrieved 2026-08-07.

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