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AVMAPKI FAKZYNJA CO-PACK (COPACKAGED)

NDA

AVUTOMETINIB POTASSIUM; DEFACTINIB HYDROCHLORIDE | N219616 | VERASTEM INC

1 strength7 unique patents2 unique exclusivities

Patent Timeline

7 unique patents, 2 exclusivities by expiration date

Expiring < 1yr (1)Active (6)TodayExclusivity

2026

2027

2028

2029

2030

2031

2032

2033

2034

2035

2036

2037

2038

2039

2040

2041

2042

2043

Today

Feb. 9, 2027

Aug. 21, 2029

Apr. 17, 2028

Oct. 29, 2038

Sep. 11, 2040

Dec. 29, 2042

Dec. 29, 2042

NCE

May. 8, 2030

ODE-525

May. 8, 2032

PTAB Proceedings

No IPR/PGR/CBM challenges found at the Patent Trial and Appeal Board

Patent Reexaminations

No ex parte or inter partes reexamination proceedings found at USPTO

Hatch-Waxman Litigation

No ANDA patent litigation cases (NOS 835) matched from PACER

Citizen Petitions

No FDA citizen petitions matched from Regulations.gov

Clinical Trials

No clinical trials found on ClinicalTrials.gov for this drug

Approval Letters

1 letter from Drugs@FDA

Date	Submission	Document
May 15, 2025	ORIG -1	View Letter (PDF)

Source: Drugs@FDA application documents.

Products (1)

#001 — EQ 0.8MG BASE;EQ 200MG BASE

RLD

7 patents2 exclusivities▴

CAPSULE, TABLET;ORAL | Approved: May 8, 2025

Patents (7)

Patent #	Expiration	PED	Drug Substance	Drug Product	Use Code	Delist
7897792	Feb 9, 2027	—	Yes	Yes	—	—
7928109	Aug 21, 2029	—	Yes	Yes	—	—
8247411	Apr 17, 2028	—	Yes	Yes	—	—
11400090	Oct 29, 2038	—	—	—		—
11517573	Sep 11, 2040	—	—	—		—
11873296	Dec 29, 2042	—	—	Yes		—
12509450	Dec 29, 2042	—	—	Yes	—	—

Exclusivities (2)

Code	Date	Status
NCE	May 8, 2030	Active
ODE-525	May 8, 2032	Active

Change History (1)

Recent changes detected for this application.

ADDED7/1/2026

Verastem Inc.'s AVMAPKI FAKZYNJA CO-PACK (avutometinib potassium and defactinib hydrochloride) gained New Chemical Entity exclusivity upon approval under NDA 219616.

New: New record