KISQALI

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Mar 13, 2017

   9 yr 5 mo ago

2. Today

3. Exclusivity ends · I-950

   New indication exclusivity (3 years)

   Sep 17, 2027

   in 1 yr 3 mo

4. Exclusivity ends · PED

   Pediatric exclusivity (adds 6 months)

   Mar 17, 2028

   in 1 yr 9 mo

5. Patent 8324225 expires

   Listed drug substance patent expiration.

   Jun 17, 2028

   in 2 yr

6. Patent 8324225*PED expires

   Listed listed patent expiration.

   Dec 17, 2028

   in 2 yr 6 mo

7. Patent 9416136 expires

   Listed method-of-use patent (U-2355) expiration.

   Aug 20, 2029

   in 3 yr 3 mo

8. Patent 9416136 expires

   Listed method-of-use patent (U-2356) expiration.

   Aug 20, 2029

   in 3 yr 3 mo

9. Patent 9416136 expires

   Listed method-of-use patent (U-1981) expiration.

   Aug 20, 2029

   in 3 yr 3 mo

10. Patent 9416136 expires

    Listed method-of-use patent (U-3999) expiration.

    Aug 20, 2029

    in 3 yr 3 mo

11. Patent 9416136 expires

    Listed method-of-use patent (U-3266) expiration.

    Aug 20, 2029

    in 3 yr 3 mo

12. Patent 9416136 expires

    Listed method-of-use patent (U-3265) expiration.

    Aug 20, 2029

    in 3 yr 3 mo

13. Patent 9416136 expires

    Listed method-of-use patent (U-3975) expiration.

    Aug 20, 2029

    in 3 yr 3 mo

14. Patent 8962630 expires

    Listed method-of-use patent (U-1981) expiration.

    Dec 09, 2029

    in 3 yr 6 mo

15. Patent 8962630 expires

    Listed method-of-use patent (U-2356) expiration.

    Dec 09, 2029

    in 3 yr 6 mo

16. Patent 8962630 expires

    Listed method-of-use patent (U-2355) expiration.

    Dec 09, 2029

    in 3 yr 6 mo

17. Patent 8962630 expires

    Listed method-of-use patent (U-3999) expiration.

    Dec 09, 2029

    in 3 yr 6 mo

18. Patent 8962630 expires

    Listed method-of-use patent (U-3265) expiration.

    Dec 09, 2029

    in 3 yr 6 mo

19. Patent 8962630 expires

    Listed method-of-use patent (U-3266) expiration.

    Dec 09, 2029

    in 3 yr 6 mo

20. Patent 8962630 expires

    Listed method-of-use patent (U-3975) expiration.

    Dec 09, 2029

    in 3 yr 6 mo

21. Patent 9416136*PED expires

    Listed listed patent expiration.

    Feb 20, 2030

    in 3 yr 9 mo

22. Patent 8685980 expires

    Listed drug substance patent expiration.

    May 25, 2030

    in 4 yr

23. Patent 8962630*PED expires

    Listed listed patent expiration.

    Jun 09, 2030

    in 4 yr

24. Patent 8685980*PED expires

    Listed listed patent expiration.

    Nov 25, 2030

    in 4 yr 6 mo

25. Patent 8415355 expires

    Listed drug substance patent expiration.

    Mar 13, 2031

    in 4 yr 10 mo

26. Patent 8415355*PED expires

    Listed listed patent expiration.

    Sep 13, 2031

    in 5 yr 4 mo

27. Patent 9193732 expires

    Listed drug substance patent expiration.

    Nov 09, 2031

    in 5 yr 6 mo

28. Patent 9868739 expires

    Listed method-of-use patent (U-2355) expiration.

    Nov 09, 2031

    in 5 yr 6 mo

29. Patent 9868739 expires

    Listed method-of-use patent (U-2356) expiration.

    Nov 09, 2031

    in 5 yr 6 mo

30. Patent 9868739 expires

    Listed method-of-use patent (U-3999) expiration.

    Nov 09, 2031

    in 5 yr 6 mo

31. Patent 9868739 expires

    Listed method-of-use patent (U-1981) expiration.

    Nov 09, 2031

    in 5 yr 6 mo

32. Patent 9868739 expires

    Listed method-of-use patent (U-3975) expiration.

    Nov 09, 2031

    in 5 yr 6 mo

33. Patent 9868739 expires

    Listed method-of-use patent (U-3265) expiration.

    Nov 09, 2031

    in 5 yr 6 mo

34. Patent 9868739 expires

    Listed method-of-use patent (U-3266) expiration.

    Nov 09, 2031

    in 5 yr 6 mo

35. Patent 9193732*PED expires

    Listed listed patent expiration.

    May 09, 2032

    in 6 yr

36. Patent 9868739*PED expires

    Listed listed patent expiration.

    May 09, 2032

    in 6 yr

37. Patent 12544379 expires

    Listed method-of-use patent (U-3975) expiration.

    Aug 07, 2034

    in 8 yr 3 mo

38. Patent 12544380 expires

    Listed method-of-use patent (U-4404) expiration.

    Aug 07, 2034

    in 8 yr 3 mo

39. Patent 12544380 expires

    Listed method-of-use patent (U-4405) expiration.

    Aug 07, 2034

    in 8 yr 3 mo

40. Patent 12544379*PED expires

    Listed listed patent expiration.

    Feb 07, 2035

    in 8 yr 9 mo

41. Patent 12544380*PED expires

    Listed listed patent expiration.

    Feb 07, 2035

    in 8 yr 9 mo

42. Patent 10799506 expires

    Listed drug product patent expiration.

    Apr 14, 2036

    in 10 yr

43. Patent 12064434 expires

    Listed drug product patent expiration.

    Apr 14, 2036

    in 10 yr

44. Patent 12419894 expires

    Listed drug product patent expiration.

    Apr 14, 2036

    in 10 yr

45. Patent 10799506*PED expires

    Listed listed patent expiration.

    Oct 14, 2036

    in 10 yr 6 mo

46. Patent 12064434*PED expires

    Listed listed patent expiration.

    Oct 14, 2036

    in 10 yr 6 mo

47. Patent 12419894*PED expires

    Listed listed patent expiration.

    Oct 14, 2036

    in 10 yr 6 mo

Pharmaceutical detail

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

Marketing exclusivity (2)

• I-950New indication exclusivity (3 years)

  Sep 17, 2027

  in 1 yr 3 mo

• PEDPediatric exclusivity (adds 6 months)

  Mar 17, 2028

  in 1 yr 9 mo

Listed patents (43)