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Last Updated: December 30, 2025

Claims for Patent: 11,053,214

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Summary for Patent: 11,053,214

Title:	Compositions and methods related to pyridinoylpiperidine 5-HT1F agonists
Abstract:	The present invention provides new pseudo-polymorphs of the hemisuccinate salt of 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-yl]-benzamide which are useful in pharmaceutical compositions, for example, for the treatment and prevention of migraine headache.
Inventor(s):	Brigida Allieri, Paul Fagan, Emma Sharp, Raymond D. Skwierczynski
Assignee:	Colucid Pharmaceuticals Inc
Application Number:	US16/467,208
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,053,214
Patent Claims:	1. A crystalline Form D di-hydrate of the hemisuccinate salt of 2,4,6-trifluoro-N-[6-(1-methyl-piperidine-4-carbonyl)-pyridin-2-yl]-benzamide characterized by an X-ray diffraction pattern when measured using Cu-Kα radiation having at least peaks at about 18.7+/−0.2 degrees 2θ, 26.5+/−0.2 degrees 2θ, 27.0+/−0.2 degrees 2θ, 27.5+/−0.2 degrees 2θ and 27.8+/−0.2 degrees 2θ. 2. The crystalline di-hydrate of claim 1, wherein the X-ray diffraction pattern includes at least one or more additional peaks selected from the group consisting of the following peaks at about degrees 2θ, +/−0.2 degrees 2θ, using Cu-Kα radiation: 8.5 9.7 11.9 13.8 14.0 15.4 15.5 15.8 17.0 17.3 17.7 18.0 18.7 18.9 19.3 19.8 20.0 20.8 21.4 21.6 21.9 22.4 22.7 23.0 24.1 24.3 24.7 25.6 25.9 26.1 26.4 27.0 27.5 27.8 28.4 29.1 29.6 29.8, and 31.9. 3. The di-hydrate of claim 1, produced by a method comprising wet granulation of amorphous Compound I. 4. A pharmaceutical composition comprising the di-hydrate of claim 1 and a pharmaceutically acceptable carrier. 5. The pharmaceutical composition of claim 4, wherein said di-hydrate is substantially free from impurities. 6. The pharmaceutical composition of claim 5, wherein said di-hydrate has a chemical purity greater than 98.0% as determined by HPLC. 7. A method of treating migraine in a human in need thereof comprising administering to a mammal in need of such treatment an effective amount of the di-hydrate of claim 1.

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