TIBSOVO

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Jul 20, 2018

   8 yr ago

2. Exclusivity ends · ODE-242

   Orphan-drug exclusivity (7 years)

   May 02, 2026

   2 mo ago

3. Today

4. Exclusivity ends · I-924

   New indication exclusivity (3 years)

   Oct 24, 2026

   in 4 mo

5. Exclusivity ends · ODE-368

   Orphan-drug exclusivity (7 years)

   Aug 25, 2028

   in 2 yr 3 mo

6. Patent 10610125 expires

   Listed method-of-use patent (U-2784) expiration.

   Jun 21, 2030

   in 4 yr 1 mo

7. Patent 10610125 expires

   Listed method-of-use patent (U-2785) expiration.

   Jun 21, 2030

   in 4 yr 1 mo

8. Patent 10610125 expires

   Listed method-of-use patent (U-3385) expiration.

   Jun 21, 2030

   in 4 yr 1 mo

9. Exclusivity ends · ODE-447

   Orphan-drug exclusivity (7 years)

   Oct 24, 2030

   in 4 yr 5 mo

10. Patent 10717764 expires

    Listed method-of-use patent (U-3215) expiration.

    Jan 18, 2033

    in 6 yr 8 mo

11. Patent 11667673 expires

    Listed method-of-use patent (U-3742) expiration.

    Jan 18, 2033

    in 6 yr 8 mo

12. Patent 9850277 expires

    Listed drug substance patent expiration.

    Jan 18, 2033

    in 6 yr 8 mo

13. Patent 9850277 expires

    Listed drug substance patent expiration.

    Jan 18, 2033

    in 6 yr 8 mo

14. Patent 9850277 expires

    Listed drug substance patent expiration.

    Jan 18, 2033

    in 6 yr 8 mo

15. Patent 9850277 expires

    Listed drug substance patent expiration.

    Jan 18, 2033

    in 6 yr 8 mo

16. Patent 9850277 expires

    Listed drug substance patent expiration.

    Jan 18, 2033

    in 6 yr 8 mo

17. Patent 9850277 expires

    Listed drug substance patent expiration.

    Jan 18, 2033

    in 6 yr 8 mo

18. Patent 9474779 expires

    Listed drug substance patent expiration.

    Aug 19, 2033

    in 7 yr 3 mo

19. Patent 9474779 expires

    Listed drug substance patent expiration.

    Aug 19, 2033

    in 7 yr 3 mo

20. Patent 9474779 expires

    Listed drug substance patent expiration.

    Aug 19, 2033

    in 7 yr 3 mo

21. Patent 9474779 expires

    Listed drug substance patent expiration.

    Aug 19, 2033

    in 7 yr 3 mo

22. Patent 9474779 expires

    Listed drug substance patent expiration.

    Aug 19, 2033

    in 7 yr 3 mo

23. Patent 9474779 expires

    Listed drug substance patent expiration.

    Aug 19, 2033

    in 7 yr 3 mo

24. Patent 10449184 expires

    Listed drug product patent expiration.

    Mar 13, 2035

    in 8 yr 10 mo

25. Patent 10799490 expires

    Listed drug product patent expiration.

    Mar 13, 2035

    in 8 yr 10 mo

26. Patent 10799490 expires

    Listed drug product patent expiration.

    Mar 13, 2035

    in 8 yr 10 mo

27. Patent 10799490 expires

    Listed drug product patent expiration.

    Mar 13, 2035

    in 8 yr 10 mo

28. Patent 9968595 expires

    Listed drug product patent expiration.

    Mar 13, 2035

    in 8 yr 10 mo

29. Patent 9968595 expires

    Listed drug product patent expiration.

    Mar 13, 2035

    in 8 yr 10 mo

30. Patent 9968595 expires

    Listed drug product patent expiration.

    Mar 13, 2035

    in 8 yr 10 mo

31. Patent 9968595 expires

    Listed drug product patent expiration.

    Mar 13, 2035

    in 8 yr 10 mo

32. Patent 10653710 expires

    Listed method-of-use patent (U-3387) expiration.

    Oct 18, 2036

    in 10 yr 6 mo

33. Patent 10980788 expires

    Listed method-of-use patent (U-3214) expiration.

    Jun 07, 2039

    in 13 yr 2 mo

34. Patent 10980788 expires

    Listed method-of-use patent (U-3743) expiration.

    Jun 07, 2039

    in 13 yr 2 mo

35. Patent 10980788 expires

    Listed method-of-use patent (U-3383) expiration.

    Jun 07, 2039

    in 13 yr 2 mo

36. Patent 10980788 expires

    Listed method-of-use patent (U-3112) expiration.

    Jun 07, 2039

    in 13 yr 2 mo

37. Patent 10980788 expires

    Listed method-of-use patent (U-3113) expiration.

    Jun 07, 2039

    in 13 yr 2 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 (4)

• ODE-242Orphan-drug exclusivity (7 years)

  May 02, 2026

  2 mo ago

• I-924New indication exclusivity (3 years)

  Oct 24, 2026

  in 4 mo

• ODE-368Orphan-drug exclusivity (7 years)

  Aug 25, 2028

  in 2 yr 3 mo

• ODE-447Orphan-drug exclusivity (7 years)

  Oct 24, 2030

  in 4 yr 5 mo

Listed patents (31)