MAVYRET

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Jun 10, 2021

   5 yr 1 mo ago

2. Today

3. Exclusivity ends · I-967

   New indication exclusivity (3 years)

   Jun 10, 2028

   in 2 yr

4. Exclusivity ends · ODE-372

   Orphan-drug exclusivity (7 years)

   Jun 10, 2028

   in 2 yr

5. Exclusivity ends · PED

   Pediatric exclusivity (adds 6 months)

   Dec 10, 2028

   in 2 yr 6 mo

6. Patent 10028937 expires

   Listed method-of-use patent (U-4206) expiration.

   Jun 10, 2030

   in 4 yr

7. Patent 10028937 expires

   Listed method-of-use patent (U-3238) expiration.

   Jun 10, 2030

   in 4 yr

8. Patent 10039754 expires

   Listed method-of-use patent (U-4206) expiration.

   Jun 10, 2030

   in 4 yr

9. Patent 10039754 expires

   Listed method-of-use patent (U-3238) expiration.

   Jun 10, 2030

   in 4 yr

10. Patent 9586978 expires

    Listed method-of-use patent (U-4206) expiration.

    Nov 06, 2030

    in 4 yr 5 mo

11. Patent 9586978 expires

    Listed method-of-use patent (U-3238) expiration.

    Nov 06, 2030

    in 4 yr 5 mo

12. Patent 10028937*PED expires

    Listed listed patent expiration.

    Dec 10, 2030

    in 4 yr 7 mo

13. Patent 10039754*PED expires

    Listed listed patent expiration.

    Dec 10, 2030

    in 4 yr 7 mo

14. Patent 9586978*PED expires

    Listed listed patent expiration.

    May 06, 2031

    in 4 yr 11 mo

15. Patent 8648037 expires

    Listed drug substance patent expiration.

    Jan 19, 2032

    in 5 yr 8 mo

16. Patent 8648037 expires

    Listed drug substance patent expiration.

    Jan 19, 2032

    in 5 yr 8 mo

17. Patent 8937150 expires

    Listed drug substance patent expiration.

    May 18, 2032

    in 6 yr

18. Patent 8648037*PED expires

    Listed listed patent expiration.

    Jul 19, 2032

    in 6 yr 2 mo

19. Patent 8937150*PED expires

    Listed listed patent expiration.

    Nov 18, 2032

    in 6 yr 6 mo

20. Patent 10286029 expires

    Listed method-of-use patent (U-4206) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

21. Patent 10286029 expires

    Listed method-of-use patent (U-3238) expiration.

    Mar 14, 2034

    in 7 yr 10 mo

22. Patent 10286029*PED expires

    Listed listed patent expiration.

    Sep 14, 2034

    in 8 yr 4 mo

23. Patent RE48923 expires

    Listed drug substance patent expiration.

    May 08, 2035

    in 9 yr

24. Patent 9321807 expires

    Listed drug substance patent expiration.

    Jun 05, 2035

    in 9 yr 1 mo

25. Patent RE48923*PED expires

    Listed listed patent expiration.

    Nov 08, 2035

    in 9 yr 6 mo

26. Patent 9321807*PED expires

    Listed listed patent expiration.

    Dec 05, 2035

    in 9 yr 7 mo

Pharmaceutical detail

This is a reference-listed drug (RLD) — the basis for generic (ANDA) applications. Other products sharing this ingredient are listed below.

• MAVYRETBrand (NDA)

  NDA 209394 · ABBVIE

  2017

Marketing exclusivity (3)

• I-967New indication exclusivity (3 years)

  Jun 10, 2028

  in 2 yr

• ODE-372Orphan-drug exclusivity (7 years)

  Jun 10, 2028

  in 2 yr

• PEDPediatric exclusivity (adds 6 months)

  Dec 10, 2028

  in 2 yr 6 mo

Listed patents (21)