AUSTEDO XR

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Feb 17, 2023

   3 yr 5 mo ago

2. Today

3. Patent 8524733 expires

   Listed drug substance patent expiration.

   Apr 03, 2031

   in 4 yr 10 mo

4. Patent 8524733*PED expires

   Listed listed patent expiration.

   Oct 03, 2031

   in 5 yr 4 mo

5. Patent 9550780 expires

   Listed drug substance patent expiration.

   Sep 18, 2033

   in 7 yr 4 mo

6. Patent 9550780 expires

   Listed drug substance patent expiration.

   Sep 18, 2033

   in 7 yr 4 mo

7. Patent 9550780*PED expires

   Listed listed patent expiration.

   Mar 18, 2034

   in 7 yr 10 mo

8. Patent 10959996 expires

   Listed method-of-use patent (U-3055) expiration.

   Mar 07, 2036

   in 9 yr 10 mo

9. Patent 11357772 expires

   Listed method-of-use patent (U-1995) expiration.

   Mar 07, 2036

   in 9 yr 10 mo

10. Patent 11357772 expires

    Listed method-of-use patent (U-3055) expiration.

    Mar 07, 2036

    in 9 yr 10 mo

11. Patent 11446291 expires

    Listed method-of-use patent (U-1995) expiration.

    Mar 07, 2036

    in 9 yr 10 mo

12. Patent 11564917 expires

    Listed method-of-use patent (U-1995) expiration.

    Mar 07, 2036

    in 9 yr 10 mo

13. Patent 11648244 expires

    Listed method-of-use patent (U-1995) expiration.

    Mar 07, 2036

    in 9 yr 10 mo

14. Patent 12016858 expires

    Listed method-of-use patent (U-1995) expiration.

    Mar 07, 2036

    in 9 yr 10 mo

15. Patent 12016858 expires

    Listed method-of-use patent (U-3055) expiration.

    Mar 07, 2036

    in 9 yr 10 mo

16. Patent 10959996*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

17. Patent 11357772*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

18. Patent 11446291*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

19. Patent 11564917*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

20. Patent 11648244*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

21. Patent 12016858*PED expires

    Listed listed patent expiration.

    Sep 07, 2036

    in 10 yr 4 mo

22. Patent 11179386 expires

    Listed drug product patent expiration.

    Mar 15, 2038

    in 11 yr 11 mo

23. Patent 11179386 expires

    Listed drug product patent expiration.

    Mar 15, 2038

    in 11 yr 11 mo

24. Patent 11813232 expires

    Listed drug product patent expiration.

    Mar 15, 2038

    in 11 yr 11 mo

25. Patent 11179386*PED expires

    Listed listed patent expiration.

    Sep 15, 2038

    in 12 yr 5 mo

26. Patent 11813232*PED expires

    Listed listed patent expiration.

    Sep 15, 2038

    in 12 yr 5 mo

27. Patent 11311488 expires

    Listed drug product patent expiration.

    Jun 10, 2041

    in 15 yr 2 mo

28. Patent 11311488 expires

    Listed drug product patent expiration.

    Jun 10, 2041

    in 15 yr 2 mo

29. Patent 12589075 expires

    Listed method-of-use patent (U-3055) expiration.

    Jun 10, 2041

    in 15 yr 2 mo

30. Patent 12589075 expires

    Listed method-of-use patent (U-1995) expiration.

    Jun 10, 2041

    in 15 yr 2 mo

31. Patent 12599598 expires

    Listed method-of-use patent (U-3055) expiration.

    Jun 10, 2041

    in 15 yr 2 mo

32. Patent 12599598 expires

    Listed method-of-use patent (U-1995) expiration.

    Jun 10, 2041

    in 15 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.

• AUSTEDOBrand (NDA)

  NDA 208082 · TEVA BRANDED PHARM

  2017
• DEUTETRABENAZINEGeneric (ANDA)

  ANDA 215971 · AUROBINDO PHARMA LTD

  2024

Listed patents (30)