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Last Updated: December 16, 2025

Claims for Patent: 11,236,121

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Summary for Patent: 11,236,121

Title:	Crystalline 19-nor C3,3-disubstituted C21-N-pyrazolyl steroid
Abstract:	This invention relates to a 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I) and crystalline solid forms and compositions thereof. Also disclosed herein are methods of making crystalline solid forms of the 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I) and methods of using the 19-nor C3,3-disubstituted C21-pyrazolyl steroid of Formula (I) or crystalline solid forms, pharmaceutically acceptable salts, and pharmaceutically acceptable compositions thereof.
Inventor(s):	Paul Steven Watson, Bret Berner, John Gregory Reid, Jian Wang, James J. Doherty, Stephen Jay Kanes
Assignee:	Sage Therapeutics Inc
Application Number:	US16/326,977
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,236,121
Patent Claims:	1. A crystalline solid form of Compound 1: having an XRPD pattern comprising peaks between and including 9.7 to 10.1 degrees in 2θ, between and including 11.6 to 12.0 degrees in 2θ, between and including 13.2 to 13.6 degrees in 2θ, between and including 14.2 to 14.6 degrees in 2θ, between and including 14.6 to 15.0 degrees in 2θ, between and including 16.8 to 17.2 degrees in 2θ, between and including 20.5 to 20.9 degrees in 2θ, between and including 21.3 to 21.7 degrees in 2θ, between and including 21.4 to 21.8 degrees in 2θ, and between and including 22.4 to 22.8 degrees in 2θ. 2. The crystalline solid form of claim 1, wherein the peak between and including 9.7 to 10.1 is 9.9 degrees in 2θ, the peak between and including 11.6 to 12.0 is 11.8 degrees in 2θ, the peak between and including 13.2 to 13.6 is 13.4 degrees in 2θ, the peak between and including 14.2 to 14.6 is 14.4 degrees in 2θ, the peak between and including 14.6 to 15.0 degrees is 14.8 in 20, the peak between and including 16.8 to 17.2 is 17.0 degrees in 2θ, the peak between and including 20.5 to 20.9 is 20.7 degrees in 2θ, the peak between and including 21.3 to 21.7 is 21.5 degrees in 2θ, the peak between and including 21.4 to 21.8 is 21.6 degrees in 2θ, and the peak between and including 22.4 to 22.8 is 22.6 degrees in 2θ. 3. A crystalline solid form of Compound 1: having an XRPD pattern comprising peaks between and including 9.7 to 10.1 degrees in 2θ, between and including 14.6 to 15.0 degrees in 2θ, between and including 16.8 to 17.2 degrees in 2θ, between and including 20.5 to 20.9 degrees in 2θ, between and including 21.3 to 21.7 degrees in 2θ. 4. The crystalline solid form of claim 3, wherein the peak between and including 9.7 to 10.1 is 9.9 degrees in 2θ, the peak between and including 14.6 to 15.0 is 14.8 degrees in 2θ, the peak between and including 16.8 to 17.2 is 17.0 degrees in 2θ, the peak between and including 20.5 to 20.9 is 20.7 degrees in 2θ, and the peak between and including 21.3 to 21.7 is 21.5 degrees in 2θ. 5. The A crystalline solid form of Compound 1: having an XRPD pattern comprising peaks at 9.9 degrees in 2θ, 14.8 degrees in 2θ, 17.0 degrees in 2θ, 20.7 degrees in 2θ, and 21.5 degrees in 2θ.

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