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Last Updated: March 18, 2026

Claims for Patent: 11,453,641

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Summary for Patent: 11,453,641

Title:	Methods of treating neurofibromatosis with N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodophenylamino)-benzamide
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:	US17/357,593
Patent Claims:	1. A method of treating Neurofibromatosis in a patient in need thereof comprising administering a pharmaceutical composition comprising 1 mg to 4 mg N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide Form IV characterized by an XRPD pattern having peaks at 4.6±0.2, 13.5±0.2 and 16.7±0.2 degrees two theta. 2. The method of claim 1 wherein the pharmaceutical composition comprises 1 mg N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide. 3. The method of claim 1 wherein the pharmaceutical composition comprises 2 mg N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide. 4. The method of claim 1 wherein the pharmaceutical composition comprises 3 mg N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide. 5. The method of claim 1 wherein the pharmaceutical composition comprises 4 mg N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide. 6. A method of treating Neurofibromatosis in a patient in need thereof comprising administering a pharmaceutical composition comprising 1 mg to 4 mg N-((R)-2,3-dihydroxypropoxy)-3,4-difluoro-2-(2-fluoro-4-iodo-phenylamino)-benzamide Form IV characterized by an XRPD pattern substantially as shown in FIG. 1A.

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