SYMDEKO (COPACKAGED)

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Jun 21, 2019

   7 yr 1 mo ago

2. Today

3. Exclusivity ends · ODE-247

   Orphan-drug exclusivity (7 years)

   Jun 21, 2026

   in 2 d

4. Patent 8354427 expires

   Listed method-of-use patent (U-3021) expiration.

   Jul 06, 2026

   in 17 d

5. Patent 8410274 expires

   Listed drug product patent expiration.

   Dec 28, 2026

   in 6 mo

6. Patent 8754224 expires

   Listed drug substance patent expiration.

   Dec 28, 2026

   in 6 mo

7. Patent 9670163 expires

   Listed drug product patent expiration.

   Dec 28, 2026

   in 6 mo

8. Patent 9931334 expires

   Listed drug product patent expiration.

   Dec 28, 2026

   in 6 mo

9. Patent 9931334 expires

   Listed drug product patent expiration.

   Dec 28, 2026

   in 6 mo

10. Patent 10022352 expires

    Listed drug product patent expiration.

    Apr 09, 2027

    in 10 mo

11. Patent 10022352 expires

    Listed drug product patent expiration.

    Apr 09, 2027

    in 10 mo

12. Patent 10239867 expires

    Listed drug substance patent expiration.

    Apr 09, 2027

    in 10 mo

13. Patent 10239867 expires

    Listed drug substance patent expiration.

    Apr 09, 2027

    in 10 mo

14. Patent 11639347 expires

    Listed drug substance patent expiration.

    Apr 09, 2027

    in 10 mo

15. Patent 9974781 expires

    Listed drug product patent expiration.

    Apr 09, 2027

    in 10 mo

16. Patent 9974781 expires

    Listed drug product patent expiration.

    Apr 09, 2027

    in 10 mo

17. Patent 7645789 expires

    Listed drug substance patent expiration.

    May 01, 2027

    in 11 mo

18. Patent 8598181 expires

    Listed method-of-use patent (U-2246) expiration.

    May 01, 2027

    in 11 mo

19. Patent 8623905 expires

    Listed drug substance patent expiration.

    May 01, 2027

    in 11 mo

20. Patent 7495103 expires

    Listed drug substance patent expiration.

    May 20, 2027

    in 11 mo

21. Patent 7776905 expires

    Listed drug substance patent expiration.

    Jun 03, 2027

    in 1 yr

22. Patent 8324242 expires

    Listed method-of-use patent (U-2246) expiration.

    Aug 05, 2027

    in 1 yr 2 mo

23. Patent 8415387 expires

    Listed method-of-use patent (U-2246) expiration.

    Nov 12, 2027

    in 1 yr 5 mo

24. Exclusivity ends · ODE-335

    Orphan-drug exclusivity (7 years)

    Dec 21, 2027

    in 1 yr 6 mo

25. Patent 10646481 expires

    Listed drug product patent expiration.

    Aug 13, 2029

    in 3 yr 2 mo

26. Patent 11564916 expires

    Listed method-of-use patent (U-3527) expiration.

    Aug 13, 2029

    in 3 yr 2 mo

27. Patent 12458635 expires

    Listed drug product patent expiration.

    Aug 13, 2029

    in 3 yr 2 mo

28. Patent 10081621 expires

    Listed drug product patent expiration.

    Mar 25, 2031

    in 4 yr 10 mo

29. Patent 10081621 expires

    Listed drug product patent expiration.

    Mar 25, 2031

    in 4 yr 10 mo

30. Patent 11578062 expires

    Listed drug product patent expiration.

    Mar 25, 2031

    in 4 yr 10 mo

31. Patent RE50453 expires

    Listed drug substance patent expiration.

    Jul 10, 2031

    in 5 yr 2 mo

32. Patent 10058546 expires

    Listed method-of-use patent (U-3022) expiration.

    Jul 15, 2033

    in 7 yr 2 mo

33. Patent 10058546 expires

    Listed method-of-use patent (U-3023) expiration.

    Jul 15, 2033

    in 7 yr 2 mo

34. Patent 9012496 expires

    Listed method-of-use patent (U-2248) expiration.

    Jul 15, 2033

    in 7 yr 2 mo

35. Patent 10206877 expires

    Listed drug product patent expiration.

    Apr 14, 2035

    in 8 yr 11 mo

36. Patent 10206877 expires

    Listed drug product patent expiration.

    Apr 14, 2035

    in 8 yr 11 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)

• ODE-247Orphan-drug exclusivity (7 years)

  Jun 21, 2026

  in 2 d

• ODE-335Orphan-drug exclusivity (7 years)

  Dec 21, 2027

  in 1 yr 6 mo

Listed patents (32)