Details for Patent: 11,066,358

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Which drugs does patent 11,066,358 protect, and when does it expire?

Patent 11,066,358 protects GOMEKLI and is included in two NDAs.

Summary for Patent: 11,066,358

Title:	Compositions of essentially pure form IV of N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide and uses thereof
Abstract:	The present disclosure relates to: a) a crystalline composition of essentially pure Form IV of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide; b) pharmaceutical compositions comprising the crystalline composition of essentially pure Form IV of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide, and, optionally, a pharmaceutically acceptable carrier; and c) methods of treating a tumor, a cancer, or a Rasopathy disorder by administering the crystalline composition of essentially pure Form IV of N—((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide to a subject in need thereof.
Inventor(s):	Erwin Irdam
Assignee:	Warner Lambert Co LLC
Application Number:	US17/178,022
Patent Claim Types: see list of patent claims	Composition; Compound; Dosage form;

Drugs Protected by US Patent 11,066,358

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Patented / Exclusive Use	Submissiondate
Springworks	GOMEKLI	mirdametinib	CAPSULE;ORAL	219389-001	Feb 11, 2025		RX	Yes	No				Y
Springworks	GOMEKLI	mirdametinib	CAPSULE;ORAL	219389-002	Feb 11, 2025		RX	Yes	Yes				Y
Springworks	GOMEKLI	mirdametinib	TABLET, FOR SUSPENSION;ORAL	219379-001	Feb 11, 2025		RX	Yes	Yes				Y
Springworks	GOMEKLI	mirdametinib	TABLET, FOR SUSPENSION;ORAL	219379-002	Jul 28, 2026		RX	Yes	No			Y	Y
Springworks	GOMEKLI	mirdametinib	TABLET, FOR SUSPENSION;ORAL	219379-003	Jul 28, 2026		RX	Yes	No			Y	Y