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Last Updated: December 12, 2025

Claims for Patent: 11,566,011

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Summary for Patent: 11,566,011

Title:	Highly purified pharmaceutical grade tasimelteon
Abstract:	A process for preparing a batch of highly purified, pharmaceutical grade tasimelteon comprises analyzing a batch of tasimelteon synthesized under GMP conditions for the presence of one or more identified impurities.
Inventor(s):	Deepak Phadke, Natalie M. Platt, Ravi K. Pandrapragada
Assignee:	Vanda Pharmaceuticals Inc
Application Number:	US17/455,308
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,566,011
Patent Claims:	1. A pharmaceutical composition comprising: tasimelteon that is at least 90.0 area % pure and comprises no more than 0.15 wt % each of one or more impurities selected from a group consisting of: N-(((1R,2R)-2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl)methyl)-3-methylbutanamide (Impurity 1), N-(((1R,2R)-2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl)methyl)-pentanamide (Impurity 2), 1,3-Bis(((1R,2R)-2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl)methyl)urea (Impurity 3), N-(((1R,2R)-2-(benzofuran-4-yl)cyclopropyl)methyl) propionamide (Impurity 4), N-((2-(2,3-dihydrobenzofuran-4-yl)-1-((2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl) (propionamido)methyl) cyclopropyl)methyl)propionamide (Impurity 5), 2-hydroxy-6-(2-(propionamidomethyl)cyclopropyl)phenethyl 2-(2-hydroxyethyl)-3-(2-(propionamidomethyl)cyclopropyl) phenyl carbonate (Impurity 6), and N-(((1R,2R)-2-(3-Oxo-2,3-dihydrobenzofuran-4-yl)cyclopropyl) methyl)propionamide (Impurity 7); and at least one pharmaceutically acceptable excipient. 2. The pharmaceutical composition of claim 1 in pharmaceutical dosage unit form. 3. The pharmaceutical composition of claim 1, wherein the tasimelteon has been analyzed and shown to comprise no more than 0.15 wt % each of the one or more impurities. 4. A pharmaceutical composition comprising: purified tasimelteon that does not contain any of the following impurities at a concentration greater than about 0.15%:N-(((1R,2R)-2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl)methyl)-3-methylbutanamide (Impurity 1), N-(((1R,2R)-2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl)methyl)-pentanamide (Impurity 2), 1,3-Bis(((1R,2R)-2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl)methyl)urea (Impurity 3), N-(((1R,2R)-2-(benzofuran-4-yl)cyclopropyl)methyl)propionamide (Impurity 4), N-((2-(2,3-dihydrobenzofuran-4-yl)-1-((2-(2,3-dihydrobenzofuran-4-yl)cyclopropyl) (propionamido)methyl) cyclopropyl)methyl)propionamide (Impurity 5), 2-hydroxy-6-(2-(propionamidomethyl)cyclopropyl) phenethyl 2-(2-hydroxyethyl)-3-(2-(propionamidomethyl)cyclopropyl)phenyl carbonate (Impurity 6), and N-(((1R,2R)-2-(3-Oxo-2,3-dihydrobenzofuran-4-yl)cyclopropyl)methyl)propionamide (Impurity 7); and at least one pharmaceutically acceptable excipient. 5. The pharmaceutical composition of claim 4 in pharmaceutical dosage unit form.

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