Claims for Patent: 11,975,017

Summary for Patent: 11,975,017

Title:	Compositions comprising an RNA polymerase inhibitor and cyclodextrin for treating viral infections
Abstract:	The present disclosure provides a composition comprising Compound 1, or a pharmaceutically acceptable salt thereof, cyclodextrin, and, optionally, pH adjusting agents.
Inventor(s):	Nate Larson, Robert G. Strickley
Assignee:	Gilead Sciences Inc
Application Number:	US17/585,651
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for patent 11,975,017
Patent Claims:	1. A composition comprising Compound 1 or a pharmaceutically acceptable salt thereof, and cyclodextrin; wherein the composition is a lyophilized composition, wherein the composition comprises less than about 1% of impurity via HPLC following storage for 18 months at a temperature of 25° C. (±1° C.) and a relative humidity of 60% (±1%). 2. The composition of claim 1, wherein the cyclodextrin is a beta-cyclodextrin. 3. The composition of claim 2, wherein the beta-cyclodextrin is sulfobutylalkyl ether-beta-cyclodextrin, betadex-sulfobutylether sodium, or hydroxypropyl-beta-cyclodextrin. 4. The composition of claim 2, wherein the beta-cyclodextrin is betadex-sulfobutylether sodium. 5. The composition of claim 1, comprising less than about 0.5% of impurity via HPLC. 6. The composition of claim 1, further comprising a pH adjusting agent. 7. The composition of claim 6, wherein the pH adjusting agent comprises HCl, NaOH, or a combination thereof. 8. The composition of claim 6, wherein the pH adjusting agent is HCl. 9. The composition of claim 6, wherein the pH adjusting agent is NaOH. 10. The composition of claim 1, wherein the composition has a pH of about 3 to about 4. 11. The composition of claim 6, comprising Compound 1 in an amount from 1% to 10% w/w; and cyclodextrin in an amount from 90% to 99% w/w. 12. The composition of claim 6, comprising Compound 1 in an amount from 1% to 5% w/w; and cyclodextrin in an amount from 95% to 99% w/w. 13. The composition of claim 6, comprising Compound 1 in an amount from 2% to 4% w/w; and cyclodextrin in an amount from 96% to 98% w/w. 14. The composition of claim 6, comprising Compound 1 in an amount from 3% to 3.5% w/w; and cyclodextrin in an amount from 96.5% to 97% w/w. 15. The composition of claim 6, comprising Compound 1 in an amount of about 3.2% w/w; and betadex-sulfobutylether sodium in an amount of about 96.8% w/w. 16. The composition of claim 6, consisting essentially of Compound 1 in an amount of about 3.2% w/w; and betadex-sulfobutylether sodium in an amount of about 96.8% w/w. 17. A composition comprising Compound 1 or a pharmaceutically acceptable salt thereof, and cyclodextrin; wherein the composition is a lyophilized composition; wherein the composition comprises less than about 1% of impurity via HPLC following storage for 18 months at a temperature of 30° C. (±1° C.) and a relative humidity of 75% (±1%). 18. The composition of claim 17, wherein the cyclodextrin is a beta-cyclodextrin. 19. The composition of claim 18, wherein the beta-cyclodextrin is sulfobutylalkylether-beta-cyclodextrin, betadex-sulfobutylether sodium, or hydroxypropyl-beta-cyclodextrin. 20. The composition of claim 18, wherein the beta-cyclodextrin is betadex-sulfobutylether sodium. 21. The composition of claim 17, comprising less than about 0.5% of impurity via HPLC. 22. The composition of claim 17, further comprising a pH adjusting agent. 23. The composition of claim 22, wherein the pH adjusting agent comprises HCl, NaOH, or a combination thereof. 24. The composition of claim 22, wherein the pH adjusting agent is HCl. 25. The composition of claim 22, wherein the pH adjusting agent is NaOH. 26. The composition of claim 17, wherein the composition has a pH of about 3 to about 4. 27. The composition of claim 22, comprising Compound 1 in an amount from 1% to 10% w/w; and cyclodextrin in an amount from 90% to 99% w/w. 28. The composition of claim 22, comprising Compound 1 in an amount from 1% to 5% w/w; and cyclodextrin in an amount from 95% to 99% w/w. 29. The composition of claim 22, comprising Compound 1 in an amount from 2% to 4% w/w; and cyclodextrin in an amount from 96% to 98% w/w. 30. The composition of claim 22, comprising Compound 1 in an amount from 3% to 3.5% w/w; and cyclodextrin in an amount from 96.5% to 97% w/w. 31. The composition of claim 22, comprising Compound 1 in an amount of about 3.2% w/w; and betadex-sulfobutylether sodium in an amount of about 96.8% w/w. 32. The composition of claim 22, consisting essentially of Compound 1 in an amount of about 3.2% w/w; and betadex-sulfobutylether sodium in an amount of about 96.8% w/w. 33. A composition comprising Compound 1 or a pharmaceutically acceptable salt thereof, and cyclodextrin; wherein the composition is a lyophilized composition; wherein the composition comprises less than about 1% of impurity via HPLC following storage for 6 months at a temperature of 40° C. (±1° C.) and a relative humidity of 75% (±1%). 34. The composition of claim 33, wherein the cyclodextrin is a beta-cyclodextrin. 35. The composition of claim 34, wherein the beta-cyclodextrin is sulfobutylalkylether-beta-cyclodextrin, betadex-sulfobutylether sodium, or hydroxypropyl-beta-cyclodextrin. 36. The composition of claim 34, wherein the beta-cyclodextrin is betadex-sulfobutylether sodium. 37. The composition of claim 33, comprising less than about 0.5% of impurity via HPLC. 38. The composition of claim 33, further comprising a pH adjusting agent. 39. The composition of claim 38, wherein the pH adjusting agent comprises HCl, NaOH, or a combination thereof. 40. The composition of claim 38, wherein the pH adjusting agent is HCl. 41. The composition of claim 38, wherein the pH adjusting agent is NaOH. 42. The composition of claim 33, wherein the composition has a pH of about 3 to about 4. 43. The composition of claim 38, comprising Compound 1 in an amount from 1% to 10% w/w; and cyclodextrin in an amount from 90% to 99% w/w. 44. The composition of claim 38, comprising Compound 1 in an amount from 1% to 5% w/w; and cyclodextrin in an amount from 95% to 99% w/w. 45. The composition of claim 38, comprising Compound 1 in an amount from 2% to 4% w/w; and cyclodextrin in an amount from 96% to 98% w/w. 46. The composition of claim 38, comprising Compound 1 in an amount from 3% to 3.5% w/w; and cyclodextrin in an amount from 96.5% to 97% w/w. 47. The composition of claim 38, comprising Compound 1 in an amount of about 3.2% w/w; and betadex-sulfobutylether sodium in an amount of about 96.8% w/w. 48. The composition of claim 38, consisting essentially of Compound 1 in an amount of about 3.2% w/w; and betadex-sulfobutylether sodium in an amount of about 96.8% w/w.