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Last Updated: December 12, 2025

Claims for Patent: 11,453,655


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Summary for Patent: 11,453,655
Title:Modulator of the cystic fibrosis transmembrane conductance regulator, pharmaceutical compositions, methods of treatment, and process for making the modulator
Abstract:Compounds of Formula (I):pharmaceutically acceptable salts thereof, deuterated derivatives of any of the foregoing, and metabolites of any of the foregoing are disclosed. Pharmaceutical compositions comprising the same, methods of treating cystic fibrosis using the same, and methods for making the same are also disclosed. Also disclosed are solid state forms of Compound 1 and salts and solvates thereof.
Inventor(s):Alexander Russell Abela, Timothy Alcacio, Corey Anderson, Paul Timothy Angell, Minson Baek, Jeremy J. Clemens, Thomas Cleveland, Lori Ann Ferris, Peter Diederik Jan Grootenhuis, Raymond Stanley Gross, Anton V. Gulevich, Sara Sabina Hadida Ruah, Clara Kuang-Ju Hsia, Robert M. Hughes, Pramod Virupax Joshi, Ping Kang, Ali Keshavarz-Shokri, Haripada Khatuya, Paul John Krenitsky, Jason McCartney, Mark Thomas Miller, Prasuna Paraselli, Fabrice Jean Denis Pierre, Yi Shi, Muna Shrestha, David Andrew Siesel, Kathy Stavropoulos, Andreas P. Termin, Fredrick F. Van Goor, Johnny Uy, Timothy John Young, Jinglan Zhou
Assignee: Vertex Pharmaceuticals San Diego LLC , Vertex Pharmaceuticals Inc
Application Number:US16/994,875
Patent Claims: 1. Crystalline Form A of Compound 1:

2. Crystalline Form A according to claim 1 in substantially pure form.

3. Crystalline Form A according to claim 1, characterized by an X-ray powder diffractogram having a signal at at least three two-theta values chosen from 6.6±0.2, 7.6±0.2, 9.6±0.2, 12.4±0.2, 13.1±0.2, 15.2±0.2, 16.4±0.2, 18.2±0.2, and 18.6±0.2.

4. Crystalline Form A according to claim 1, characterized by an X-ray powder diffractogram having a signal at at least three two-theta values chosen from 6.6±0.2, 9.6±0.2, 13.1±0.2, 15.2±0.2, 18.2±0.2, and 18.6±0.2.

5. Crystalline Form A according to claim 1, characterized by an X-ray powder diffractogram having a signal at three two-theta values of 6.6±0.2, 13.1±0.2, 18.2±0.2.

6. Crystalline Form A according to claim 1, characterized by an X-ray powder diffractogram having a signal at six two-theta values of 6.6±0.2, 9.6±0.2, 13.1±0.2, 15.2±0.2, 18.2±0.2, and 18.6±0.2.

7. Crystalline Form A according to claim 1, characterized by an X-ray powder diffractogram substantially similar to that in FIG. 2.

8. A pharmaceutical formulation comprising at least one crystalline form according to claim 1 and a pharmaceutically acceptable carrier.

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