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Last Updated: December 16, 2025

Claims for Patent: 11,980,623

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Summary for Patent: 11,980,623

Title:	Solid dosage formulations of an orexin receptor antagonist
Abstract:	The present invention is directed to a pharmaceutical composition comprising the compound suvorexant, or a pharmaceutically acceptable salt thereof, a concentration-enhancing polymer, and optionally a pharmaceutically acceptable surfactant.
Inventor(s):	Paul A. Harmon, Narayan Variankaval, Michael Lowinger, Chad David Brown, Francis Flanagan
Assignee:	Merck Sharp and Dohme LLC
Application Number:	US17/474,322
Patent Claims:	1. A pharmaceutical composition comprising: suvorexant in an amorphous form; and a polymer selected from the group consisting of a polyvinylpyrrolidinone-polyvinyl acetate copolymer, a polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymer, and hydroxypropyl methyl cellulose acetate succinate; wherein the pharmaceutical composition comprises 5 mg, 10 mg, 15 mg or 20 mg of suvorexant, and wherein the suvorexant is present in a form that contains at least 90 weight % of the amorphous form of suvorexant relative to other morphological forms of suvorexant. 2. The pharmaceutical composition of claim 1, wherein the polymer is a polyvinylpyrrolidinone-polyvinyl acetate copolymer. 3. The pharmaceutical composition of claim 1, wherein the polymer is polyvinyl caprolactam-polyvinyl acetate-polyethylene glycol graft copolymers. 4. The pharmaceutical composition of claim 1, wherein the polymer is hydroxypropyl methyl cellulose acetate succinate. 5. The pharmaceutical composition of claim 2, further comprising silicon dioxide. 6. The pharmaceutical composition of claim 3, further comprising silicon dioxide. 7. The pharmaceutical composition of claim 4, further comprising silicon dioxide. 8. The pharmaceutical composition of claim 1, wherein said composition is prepared by spray drying a composition comprising the suvorexant and the concentration-enhancing polymer. 9. The pharmaceutical composition of claim 1, wherein said composition is prepared by hot melt extrusion of a composition comprising the suvorexant and the concentration-enhancing polymer.

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