Claims for Patent: 12,552,792
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Summary for Patent: 12,552,792
| Title: | Solid forms of an FGFR inhibitor and processes for preparing the same |
| Abstract: | The present disclosure relates to 3-(2,6-difluoro-3,5-dimethoxyphenyl)-1-ethyl-8-(morpholin-4-ylmethyl)-1,3,4,7-tetrahydro-2H-pyrrolo[3′,2′:5,6]pyrido[4,3-d]pyrimidin-2-one, solid forms and polymorphs thereof, methods of preparation thereof, and intermediates in the preparation thereof, which are useful in the treatment of the FGFR-associated or mediated diseases such as cancer. |
| Inventor(s): | William Frietze, Zhongjiang Jia, Ming Tao, Jiacheng Zhou |
| Assignee: | Incyte Corp |
| Application Number: | US17/931,377 |
| Patent Claims: |
1. A solid form of Compound 1 having the formula: wherein the solid form is crystalline Form I, having characteristic X-Ray Powder Diffraction (“XRPD”) peaks at 6.8±0.2, 9.6±0.2, 12.9±0.2, 18.6±0.2, 19.4±0.2, 22.6±0.2, 25.4±0.2, 25.8±0.2, 26.2±0.2, and 27.5±0.2 degrees 2-theta. 2. The solid form of claim 1, wherein the XRPD is measured using X-ray radiation from copper. 3. The solid form of claim 1, having at least one endothermic peak at a temperature of 276° C.±3° C. in a differential scanning calorimetry (“DSC”) thermogram. 4. The solid form of claim 3, further having an endothermic peak at a temperature of 201° C.±3° C. in a DSC thermogram. 5. The solid form of claim 1, wherein Form I is isolated with a crystalline purity greater than about 99%. 6. The solid form of claim 1, wherein Form I is isolated with a crystalline purity greater than about 98%. 7. The solid form of claim 1, wherein Form I is isolated with a crystalline purity greater than about 97%. 8. The solid form of claim 1, wherein Form I is isolated with a crystalline purity greater than about 95%. 9. The solid form of claim 1, wherein Form I is isolated with a crystalline purity greater than about 90%. 10. A pharmaceutical composition comprising a solid form of claim 1, and a pharmaceutically acceptable excipient. 11. A solid form of Compound 1 having the formula: wherein the solid form is crystalline Form I, having characteristic XRPD peaks at 12.9±0.2, 25.4±0.2, and 27.5±0.2 degrees 2-theta; and wherein Form I has endothermic peaks at temperatures of 201° C.±3° C. and 276° C.±3° C. in a DSC thermogram. 12. The solid form of claim 11, further comprising characteristic XRPD peaks at 6.8±0.2, 25.8±0.2, and 26.2±0.2 degrees 2-theta. 13. The solid form of claim 11, wherein the XRPD is measured using X-ray radiation from copper. 14. The solid form of claim 11, wherein Form I is isolated with a crystalline purity greater than about 99%. 15. The solid form of claim 11, wherein Form I is isolated with a crystalline purity greater than about 98%. 16. The solid form of claim 11, wherein Form I is isolated with a crystalline purity greater than about 97%. 17. The solid form of claim 11, wherein Form I is isolated with a crystalline purity greater than about 95%. 18. The solid form of claim 11, wherein Form I is isolated with a crystalline purity greater than about 90%. 19. A pharmaceutical composition comprising a solid form of claim 11, and a pharmaceutically acceptable excipient. 20. A solid form of Compound 1 having the formula: wherein the solid form is crystalline Form I, having an XRPD pattern with characteristic peaks as substantially shown in FIG. 1 . 21. The solid form of claim 20, wherein the XRPD is measured using X-ray radiation from copper. 22. The solid form of claim 20, having at least one endothermic peak at a temperature of 276° C.±3° C. in a DSC thermogram. 23. The solid form of claim 22, further having an endothermic peak at a temperature of 201° C.±3° C. in a DSC thermogram. 24. The solid form of claim 1 or 20, having a DSC thermogram substantially as depicted in FIG. 2 . 25. The solid form of claim 1, 11, or 20, having a TGA thermogram substantially as depicted in FIG. 3 . 26. The solid form of claim 20, wherein Form I is isolated with a crystalline purity greater than about 99%. 27. The solid form of claim 20, wherein Form I is isolated with a crystalline purity greater than about 98%. 28. The solid form of claim 20, wherein Form I is isolated with a crystalline purity greater than about 97%. 29. The solid form of claim 20, wherein Form I is isolated with a crystalline purity greater than about 95%. 30. The solid form of claim 20, wherein Form I is isolated with a crystalline purity greater than about 90%. 31. A pharmaceutical composition comprising a solid form of claim 20, and a pharmaceutically acceptable excipient. |
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