RETEVMO

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Apr 10, 2024

   2 yr 3 mo ago

2. Today

3. Exclusivity ends · ODE*

   FDA marketing exclusivity

   May 08, 2027

   in 11 mo

4. Exclusivity ends · ODE*

   FDA marketing exclusivity

   May 08, 2027

   in 11 mo

5. Exclusivity ends · ODE*

   FDA marketing exclusivity

   May 08, 2027

   in 11 mo

6. Exclusivity ends · M-311

   New use / labeling-change exclusivity (3 years)

   Sep 27, 2027

   in 1 yr 4 mo

7. Exclusivity ends · M-312

   New use / labeling-change exclusivity (3 years)

   Sep 27, 2027

   in 1 yr 4 mo

8. Exclusivity ends · PED

   Pediatric exclusivity (adds 6 months)

   Nov 08, 2027

   in 1 yr 5 mo

9. Exclusivity ends · PED

   Pediatric exclusivity (adds 6 months)

   Nov 08, 2027

   in 1 yr 5 mo

10. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Nov 08, 2027

    in 1 yr 5 mo

11. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Mar 27, 2028

    in 1 yr 10 mo

12. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Mar 27, 2028

    in 1 yr 10 mo

13. Exclusivity ends · ODE*

    FDA marketing exclusivity

    Sep 21, 2029

    in 3 yr 4 mo

14. Exclusivity ends · ODE*

    FDA marketing exclusivity

    Sep 21, 2029

    in 3 yr 4 mo

15. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Mar 21, 2030

    in 3 yr 10 mo

16. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Mar 21, 2030

    in 3 yr 10 mo

17. Exclusivity ends · ODE*

    FDA marketing exclusivity

    May 29, 2031

    in 5 yr

18. Exclusivity ends · ODE*

    FDA marketing exclusivity

    May 29, 2031

    in 5 yr

19. Exclusivity ends · ODE*

    FDA marketing exclusivity

    May 29, 2031

    in 5 yr

20. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Nov 29, 2031

    in 5 yr 6 mo

21. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Nov 29, 2031

    in 5 yr 6 mo

22. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Nov 29, 2031

    in 5 yr 6 mo

23. Patent 10112942 expires

    Listed drug substance patent expiration.

    Oct 10, 2037

    in 11 yr 6 mo

24. Patent 10137124 expires

    Listed method-of-use patent (U-3450) expiration.

    Oct 10, 2037

    in 11 yr 6 mo

25. Patent 10137124 expires

    Listed method-of-use patent (U-3949) expiration.

    Oct 10, 2037

    in 11 yr 6 mo

26. Patent 10137124 expires

    Listed method-of-use patent (U-3950) expiration.

    Oct 10, 2037

    in 11 yr 6 mo

27. Patent 10137124 expires

    Listed method-of-use patent (U-3951) expiration.

    Oct 10, 2037

    in 11 yr 6 mo

28. Patent 10172851 expires

    Listed method-of-use patent (U-3450) expiration.

    Oct 10, 2037

    in 11 yr 6 mo

29. Patent 10172851 expires

    Listed method-of-use patent (U-3949) expiration.

    Oct 10, 2037

    in 11 yr 6 mo

30. Patent 10172851 expires

    Listed method-of-use patent (U-3950) expiration.

    Oct 10, 2037

    in 11 yr 6 mo

31. Patent 10172851 expires

    Listed method-of-use patent (U-3951) expiration.

    Oct 10, 2037

    in 11 yr 6 mo

32. Patent 10112942*PED expires

    Listed listed patent expiration.

    Apr 10, 2038

    in 12 yr

33. Patent 10137124*PED expires

    Listed listed patent expiration.

    Apr 10, 2038

    in 12 yr

34. Patent 10172851*PED expires

    Listed listed patent expiration.

    Apr 10, 2038

    in 12 yr

35. Patent 12138250 expires

    Listed method-of-use patent (U-3450) expiration.

    Oct 10, 2038

    in 12 yr 6 mo

36. Patent 12138250 expires

    Listed method-of-use patent (U-3949) expiration.

    Oct 10, 2038

    in 12 yr 6 mo

37. Patent 12138250 expires

    Listed method-of-use patent (U-3951) expiration.

    Oct 10, 2038

    in 12 yr 6 mo

38. Patent 12138250 expires

    Listed method-of-use patent (U-3950) expiration.

    Oct 10, 2038

    in 12 yr 6 mo

39. Patent 12138250*PED expires

    Listed listed patent expiration.

    Apr 10, 2039

    in 13 yr

Pharmaceutical detail

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

• RETEVMOBrand (NDA)

  NDA 213246 · ELI LILLY AND CO

  2020

Marketing exclusivity (20)

• ODE*FDA marketing exclusivity

  May 08, 2027

  in 11 mo

• ODE*FDA marketing exclusivity

  May 08, 2027

  in 11 mo

• ODE*FDA marketing exclusivity

  May 08, 2027

  in 11 mo

• M-311New use / labeling-change exclusivity (3 years)

  Sep 27, 2027

  in 1 yr 4 mo

• M-312New use / labeling-change exclusivity (3 years)

  Sep 27, 2027

  in 1 yr 4 mo

• PEDPediatric exclusivity (adds 6 months)

  Nov 08, 2027

  in 1 yr 5 mo

• PEDPediatric exclusivity (adds 6 months)

  Nov 08, 2027

  in 1 yr 5 mo

• PEDPediatric exclusivity (adds 6 months)

  Nov 08, 2027

  in 1 yr 5 mo

• PEDPediatric exclusivity (adds 6 months)

  Mar 27, 2028

  in 1 yr 10 mo

• PEDPediatric exclusivity (adds 6 months)

  Mar 27, 2028

  in 1 yr 10 mo

• ODE*FDA marketing exclusivity

  Sep 21, 2029

  in 3 yr 4 mo

• ODE*FDA marketing exclusivity

  Sep 21, 2029

  in 3 yr 4 mo

• PEDPediatric exclusivity (adds 6 months)

  Mar 21, 2030

  in 3 yr 10 mo

• PEDPediatric exclusivity (adds 6 months)

  Mar 21, 2030

  in 3 yr 10 mo

• ODE*FDA marketing exclusivity

  May 29, 2031

  in 5 yr

• ODE*FDA marketing exclusivity

  May 29, 2031

  in 5 yr

• ODE*FDA marketing exclusivity

  May 29, 2031

  in 5 yr

• PEDPediatric exclusivity (adds 6 months)

  Nov 29, 2031

  in 5 yr 6 mo

• PEDPediatric exclusivity (adds 6 months)

  Nov 29, 2031

  in 5 yr 6 mo

• PEDPediatric exclusivity (adds 6 months)

  Nov 29, 2031

  in 5 yr 6 mo

Listed patents (17)