ROZLYTREK

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Aug 15, 2019

   6 yr 11 mo ago

2. Today

3. Exclusivity ends · ODE-265

   Orphan-drug exclusivity (7 years)

   Aug 15, 2026

   in 2 mo

4. Exclusivity ends · ODE-313

   Orphan-drug exclusivity (7 years)

   Aug 15, 2026

   in 2 mo

5. Exclusivity ends · NPP

   New patient population exclusivity (3 years)

   Oct 20, 2026

   in 4 mo

6. Patent 8673893 expires

   Listed method-of-use patent (U-2618) expiration.

   Jul 08, 2028

   in 2 yr 1 mo

7. Patent 8673893 expires

   Listed method-of-use patent (U-2617) expiration.

   Jul 08, 2028

   in 2 yr 1 mo

8. Patent 9029356 expires

   Listed drug substance patent expiration.

   Jul 08, 2028

   in 2 yr 1 mo

9. Patent 9085558 expires

   Listed drug product patent expiration.

   Jul 08, 2028

   in 2 yr 1 mo

10. Patent 9255087 expires

    Listed method-of-use patent (U-2618) expiration.

    Jul 08, 2028

    in 2 yr 1 mo

11. Patent 9255087 expires

    Listed method-of-use patent (U-2617) expiration.

    Jul 08, 2028

    in 2 yr 1 mo

12. Patent 9616059 expires

    Listed method-of-use patent (U-2618) expiration.

    Jul 08, 2028

    in 2 yr 1 mo

13. Exclusivity ends · ODE-448

    Orphan-drug exclusivity (7 years)

    Oct 20, 2030

    in 4 yr 5 mo

14. Patent 8299057 expires

    Listed drug substance patent expiration.

    Mar 10, 2032

    in 5 yr 10 mo

15. Patent 9085565 expires

    Listed drug substance patent expiration.

    May 22, 2033

    in 7 yr

16. Patent 9649306 expires

    Listed method-of-use patent (U-2618) expiration.

    May 22, 2033

    in 7 yr

17. Patent 9649306 expires

    Listed method-of-use patent (U-2617) expiration.

    May 22, 2033

    in 7 yr

18. Patent 10231965 expires

    Listed method-of-use patent (U-2618) expiration.

    Feb 17, 2035

    in 8 yr 10 mo

19. Patent 10231965 expires

    Listed method-of-use patent (U-2617) expiration.

    Feb 17, 2035

    in 8 yr 10 mo

20. Patent 10561651 expires

    Listed method-of-use patent (U-2745) expiration.

    Feb 19, 2035

    in 8 yr 10 mo

21. Patent 10738037 expires

    Listed drug substance patent expiration.

    May 18, 2037

    in 11 yr 1 mo

22. Patent 11091469 expires

    Listed method-of-use patent (U-2617) expiration.

    May 18, 2037

    in 11 yr 1 mo

23. Patent 11091469 expires

    Listed method-of-use patent (U-2618) expiration.

    May 18, 2037

    in 11 yr 1 mo

24. Patent 10398693 expires

    Listed drug product patent expiration.

    Jul 18, 2038

    in 12 yr 3 mo

25. Patent 11253515 expires

    Listed drug product patent expiration.

    Jul 18, 2038

    in 12 yr 3 mo

Pharmaceutical detail

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

• ROZLYTREKBrand (NDA)

  NDA 218550 · GENENTECH INC

  2023

Marketing exclusivity (4)

• ODE-265Orphan-drug exclusivity (7 years)

  Aug 15, 2026

  in 2 mo

• ODE-313Orphan-drug exclusivity (7 years)

  Aug 15, 2026

  in 2 mo

• NPPNew patient population exclusivity (3 years)

  Oct 20, 2026

  in 4 mo

• ODE-448Orphan-drug exclusivity (7 years)

  Oct 20, 2030

  in 4 yr 5 mo

Listed patents (19)