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Last Updated: December 17, 2025

Claims for Patent: 11,560,354

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Summary for Patent: 11,560,354

Title:	Compositions comprising (R)-2-amino-3-phenylpropyl carbamate and uses thereof
Abstract:	The present invention relates to a newly identified solvate form of (R)-2-amino-3-phenylpropyl carbamate (APC) hydrochloride, a method of preparing APC hydrochloride, and methods of using the same to treat disorders. The invention further relates to methods of producing APC hydrochloride with increased purity.
Inventor(s):	Fionn Hurley
Assignee:	SK Biopharmaceuticals Co Ltd , Axsome Malta Ltd
Application Number:	US17/091,222
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,560,354
Patent Claims:	1. A composition comprising (R)-2-amino-3-phenylpropyl carbamate hydrochloride and 2-chloropropane, wherein the composition comprises less than about 5 ppm 2-chloropropane. 2. The composition of claim 1, wherein the composition comprises less than about 1 ppm 2-chloropropane. 3. The composition of claim 1, wherein the composition is a dosage form. 4. The composition of claim 3, wherein the composition is an immediate release oral dosage form. 5. The composition of claim 4, wherein the composition is a tablet or a capsule. 6. A method of treating narcolepsy, cataplexy, excessive daytime sleepiness, drug addiction, sexual dysfunction, fatigue, fibromyalgia, attention deficit/hyperactivity disorder, restless legs syndrome, depression, bipolar disorder, or obesity in a subject in need thereof, or promoting smoking cessation in a subject in need thereof, comprising administering to the subject the composition of claim 1. 7. The method of claim 6, wherein the composition is administered once per day. 8. The method of claim 6, wherein the composition is administered more than once per day.

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