CAPLYTA

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Apr 22, 2022

   4 yr 3 mo ago

2. Today

3. Patent 10464938 expires

   Listed drug product patent expiration.

   Mar 12, 2028

   in 1 yr 9 mo

4. Exclusivity ends · I-904

   New indication exclusivity (3 years)

   Nov 05, 2028

   in 2 yr 5 mo

5. Patent 9199995 expires

   Listed method-of-use patent (U-4343) expiration.

   Mar 12, 2029

   in 2 yr 9 mo

6. Patent 9199995 expires

   Listed method-of-use patent (U-2713) expiration.

   Mar 12, 2029

   in 2 yr 9 mo

7. Patent RE48825 expires

   Listed drug substance patent expiration.

   Mar 12, 2029

   in 2 yr 9 mo

8. Exclusivity ends · M-319

   New use / labeling-change exclusivity (3 years)

   Apr 24, 2029

   in 2 yr 11 mo

9. Patent 10117867 expires

   Listed method-of-use patent (U-3271) expiration.

   May 27, 2029

   in 3 yr

10. Patent 9616061 expires

    Listed drug product patent expiration.

    May 27, 2029

    in 3 yr

11. Patent 8648077 expires

    Listed drug substance patent expiration.

    Dec 01, 2029

    in 3 yr 6 mo

12. Patent RE48839 expires

    Listed method-of-use patent (U-4344) expiration.

    Aug 19, 2033

    in 7 yr 3 mo

13. Patent RE48839 expires

    Listed method-of-use patent (U-814) expiration.

    Aug 19, 2033

    in 7 yr 3 mo

14. Patent RE48839 expires

    Listed method-of-use patent (U-3271) expiration.

    Aug 19, 2033

    in 7 yr 3 mo

15. Patent 11026951 expires

    Listed method-of-use patent (U-3364) expiration.

    Dec 03, 2034

    in 8 yr 7 mo

16. Patent 9956227 expires

    Listed method-of-use patent (U-2714) expiration.

    Dec 03, 2034

    in 8 yr 7 mo

17. Patent 12409176 expires

    Listed method-of-use patent (U-4261) expiration.

    Mar 15, 2039

    in 12 yr 11 mo

18. Patent 10695345 expires

    Listed drug product patent expiration.

    Aug 30, 2039

    in 13 yr 5 mo

19. Patent 11052084 expires

    Listed drug product patent expiration.

    Aug 30, 2039

    in 13 yr 5 mo

20. Patent 11052084 expires

    Listed drug product patent expiration.

    Aug 30, 2039

    in 13 yr 5 mo

21. Patent 11052084 expires

    Listed drug product patent expiration.

    Aug 30, 2039

    in 13 yr 5 mo

22. Patent 11690842 expires

    Listed drug product patent expiration.

    Aug 30, 2039

    in 13 yr 5 mo

23. Patent 11690842 expires

    Listed drug product patent expiration.

    Aug 30, 2039

    in 13 yr 5 mo

24. Patent 11690842 expires

    Listed drug product patent expiration.

    Aug 30, 2039

    in 13 yr 5 mo

25. Patent 11806348 expires

    Listed drug product patent expiration.

    Aug 30, 2039

    in 13 yr 5 mo

26. Patent 11806348 expires

    Listed drug product patent expiration.

    Aug 30, 2039

    in 13 yr 5 mo

27. Patent 11806348 expires

    Listed drug product patent expiration.

    Aug 30, 2039

    in 13 yr 5 mo

28. Patent 11980617 expires

    Listed method-of-use patent (U-4342) expiration.

    Oct 27, 2039

    in 13 yr 7 mo

29. Patent 11980617 expires

    Listed method-of-use patent (U-3940) expiration.

    Oct 27, 2039

    in 13 yr 7 mo

30. Patent 11753419 expires

    Listed drug product patent expiration.

    Dec 10, 2040

    in 14 yr 8 mo

31. Patent 12122792 expires

    Listed drug product patent expiration.

    Dec 10, 2040

    in 14 yr 8 mo

32. Patent 12122792 expires

    Listed drug product patent expiration.

    Dec 10, 2040

    in 14 yr 8 mo

33. Patent 12122792 expires

    Listed drug product patent expiration.

    Dec 10, 2040

    in 14 yr 8 mo

34. Patent 12410195 expires

    Listed drug product patent expiration.

    Dec 10, 2040

    in 14 yr 8 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-904New indication exclusivity (3 years)

  Nov 05, 2028

  in 2 yr 5 mo

• M-319New use / labeling-change exclusivity (3 years)

  Apr 24, 2029

  in 2 yr 11 mo

Listed patents (30)