SUBLOCADE

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Nov 30, 2017

   8 yr 8 mo ago

2. Today

3. Exclusivity ends · M-314

   New use / labeling-change exclusivity (3 years)

   Feb 21, 2028

   in 1 yr 8 mo

4. Patent 10198218 expires

   Listed method-of-use patent (U-2489) expiration.

   Jun 06, 2031

   in 5 yr

5. Patent 10592168 expires

   Listed method-of-use patent (U-2489) expiration.

   Jun 06, 2031

   in 5 yr

6. Patent 9272044 expires

   Listed method-of-use patent (U-2209) expiration.

   Jun 06, 2031

   in 5 yr

7. Patent 9272044 expires

   Listed method-of-use patent (U-2178) expiration.

   Jun 06, 2031

   in 5 yr

8. Patent 9272044 expires

   Listed method-of-use patent (U-2176) expiration.

   Jun 06, 2031

   in 5 yr

9. Patent 9272044 expires

   Listed method-of-use patent (U-2177) expiration.

   Jun 06, 2031

   in 5 yr

10. Patent 9498432 expires

    Listed drug product patent expiration.

    Jun 06, 2031

    in 5 yr

11. Patent 9782402 expires

    Listed drug product patent expiration.

    Jun 06, 2031

    in 5 yr

12. Patent 9782402 expires

    Listed drug product patent expiration.

    Jun 06, 2031

    in 5 yr

13. Patent 9782402 expires

    Listed drug product patent expiration.

    Jun 06, 2031

    in 5 yr

14. Patent 9782402 expires

    Listed drug product patent expiration.

    Jun 06, 2031

    in 5 yr

15. Patent 9827241 expires

    Listed drug product patent expiration.

    Jun 06, 2031

    in 5 yr

16. Patent 9827241 expires

    Listed drug product patent expiration.

    Jun 06, 2031

    in 5 yr

17. Patent 9827241 expires

    Listed drug product patent expiration.

    Jun 06, 2031

    in 5 yr

18. Patent 9827241 expires

    Listed drug product patent expiration.

    Jun 06, 2031

    in 5 yr

19. Patent 9827241 expires

    Listed drug product patent expiration.

    Jun 06, 2031

    in 5 yr

20. Patent 10558394 expires

    Listed drug product patent expiration.

    Jun 25, 2031

    in 5 yr 1 mo

21. Patent 8975270 expires

    Listed drug product patent expiration.

    Sep 05, 2031

    in 5 yr 3 mo

22. Patent 8975270 expires

    Listed drug product patent expiration.

    Sep 05, 2031

    in 5 yr 3 mo

23. Patent 8921387 expires

    Listed drug product patent expiration.

    Jan 06, 2032

    in 5 yr 8 mo

24. Patent 8921387 expires

    Listed drug product patent expiration.

    Jan 06, 2032

    in 5 yr 8 mo

25. Patent 11000520 expires

    Listed method-of-use patent (U-3111) expiration.

    Nov 06, 2035

    in 9 yr 6 mo

26. Patent 11839611 expires

    Listed method-of-use patent (U-3111) expiration.

    Nov 06, 2035

    in 9 yr 6 mo

27. Patent 12622904 expires

    Listed method-of-use patent (U-4528) expiration.

    Nov 06, 2035

    in 9 yr 6 mo

28. Patent 10646484 expires

    Listed method-of-use patent (U-2489) expiration.

    Jun 22, 2038

    in 12 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.

• BRIXADIBrand (NDA)

  NDA 210136 · BRAEBURN

  2023
• BUTRANSBrand (NDA)

  NDA 021306 · KNOA PHARMA

  2010
• BUPRENORPHINEGeneric (ANDA)

  ANDA 207490 · STRIDES PHARMA INTL

  2022
• BUPRENORPHINEGeneric (ANDA)

  ANDA 210272 · DIFGEN PHARMS

  2021
• BUPRENORPHINEGeneric (ANDA)

  ANDA 210162 · MYLAN TECH VIATRIS

  2021
• BUPRENORPHINEGeneric (ANDA)

  ANDA 211586 · AMNEAL

  2020
• BUPRENORPHINEGeneric (ANDA)

  ANDA 204937 · WATSON LABS TEVA

  2018

Marketing exclusivity (1)

• M-314New use / labeling-change exclusivity (3 years)

  Feb 21, 2028

  in 1 yr 8 mo

Listed patents (25)