Is Verastem Inc. FDA approved?

Verastem Inc. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.

What drugs does Verastem Inc. make?

1 product is listed under Verastem Inc. in the openFDA NDC Directory, most often as kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Verastem Inc.

Data as of 24 Sept 2026 · How to read this entry

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Registered sites: 0
Active NDC listings: 1
Live patents: 7
Exclusivities: 1
Countries: 0

Exclusivity

Patents and exclusivities

Patent	Product	Covers	Expiry
7897792	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)avutometinib potassium; defactinib hydrochloride	substance, product	Feb 2027
8247411	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)avutometinib potassium; defactinib hydrochloride	substance, product	Apr 2028
7928109	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)avutometinib potassium; defactinib hydrochloride	substance, product	Aug 2029
11400090	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)avutometinib potassium; defactinib hydrochloride	use	Oct 2038
11517573	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)avutometinib potassium; defactinib hydrochloride	use	Sept 2040
11873296	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)avutometinib potassium; defactinib hydrochloride	product	Dec 2042
12509450	AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)avutometinib potassium; defactinib hydrochloride	product	Dec 2042

Product	Exclusivity	Until
AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE	ODE-525 Orphan drug	May 2032

Catalogue

Marketed products

Brand	Generic name	Form / route	NDC
AVMAPKI FAKZYNJA CO-PACK	avutometinib potassium and defactinib hydrochloride	kit	71779-623NDA

Enquiry

Common questions

Is Verastem Inc. FDA approved?: Verastem Inc. holds no registered establishment of its own; 1 drug product is listed under its name in the National Drug Code Directory, made at sites registered to other firms.
What drugs does Verastem Inc. make?: 1 product is listed under Verastem Inc. in the openFDA NDC Directory, most often as kit. The full breakdown by dosage form and route is above. A listing count is not a sales figure.

Compiled from FDA establishment registrations, the openFDA NDC Directory, the Orange Book and the FDA drug shortage database. Not claimed by the company. Sources and methodology.