MEKINIST

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   May 29, 2013

   13 yr 3 mo ago

2. Exclusivity ends · I-908

   New indication exclusivity (3 years)

   Mar 16, 2026

   3 mo ago

3. Today

4. Exclusivity ends · PED

   Pediatric exclusivity (adds 6 months)

   Sep 16, 2026

   in 3 mo

5. Patent 7378423 expires

   Listed drug substance patent expiration.

   May 29, 2027

   in 11 mo

6. Patent 7378423*PED expires

   Listed listed patent expiration.

   Nov 29, 2027

   in 1 yr 6 mo

7. Exclusivity ends · ODE-428

   Orphan-drug exclusivity (7 years)

   Mar 16, 2030

   in 3 yr 10 mo

8. Exclusivity ends · PED

   Pediatric exclusivity (adds 6 months)

   Sep 16, 2030

   in 4 yr 4 mo

9. Patent 8703781 expires

   Listed drug substance patent expiration.

   Oct 15, 2030

   in 4 yr 5 mo

10. Patent 8703781 expires

    Listed drug substance patent expiration.

    Oct 15, 2030

    in 4 yr 5 mo

11. Patent 8703781 expires

    Listed drug substance patent expiration.

    Oct 15, 2030

    in 4 yr 5 mo

12. Patent 8703781 expires

    Listed drug substance patent expiration.

    Oct 15, 2030

    in 4 yr 5 mo

13. Patent 8703781 expires

    Listed drug substance patent expiration.

    Oct 15, 2030

    in 4 yr 5 mo

14. Patent 8952018 expires

    Listed method-of-use patent (U-2020) expiration.

    Oct 15, 2030

    in 4 yr 5 mo

15. Patent 8703781*PED expires

    Listed listed patent expiration.

    Apr 15, 2031

    in 4 yr 11 mo

16. Patent 8952018*PED expires

    Listed listed patent expiration.

    Apr 15, 2031

    in 4 yr 11 mo

17. Patent 8580304 expires

    Listed drug product patent expiration.

    Jan 28, 2032

    in 5 yr 8 mo

18. Patent 9155706 expires

    Listed drug product patent expiration.

    Jan 28, 2032

    in 5 yr 8 mo

19. Patent 9271941 expires

    Listed drug product patent expiration.

    Jan 28, 2032

    in 5 yr 8 mo

20. Patent 9399021 expires

    Listed drug product patent expiration.

    Jan 28, 2032

    in 5 yr 8 mo

21. Patent 8580304*PED expires

    Listed listed patent expiration.

    Jul 28, 2032

    in 6 yr 2 mo

22. Patent 9155706*PED expires

    Listed listed patent expiration.

    Jul 28, 2032

    in 6 yr 2 mo

23. Patent 9271941*PED expires

    Listed listed patent expiration.

    Jul 28, 2032

    in 6 yr 2 mo

24. Patent 9399021*PED expires

    Listed listed patent expiration.

    Jul 28, 2032

    in 6 yr 2 mo

25. Patent 10869869 expires

    Listed method-of-use patent (U-3184) expiration.

    Aug 30, 2033

    in 7 yr 4 mo

26. Patent 10869869*PED expires

    Listed listed patent expiration.

    Feb 28, 2034

    in 7 yr 10 mo

Pharmaceutical detail

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

• MEKINISTBrand (NDA)

  NDA 217513 · NOVARTIS

  2023
• TRAMETINIB DIMETHYL SULFOXIDEGeneric (ANDA)

  ANDA 219002 · HIKMA

  2024

Marketing exclusivity (4)

• I-908New indication exclusivity (3 years)

  Mar 16, 2026

  3 mo ago

• PEDPediatric exclusivity (adds 6 months)

  Sep 16, 2026

  in 3 mo

• ODE-428Orphan-drug exclusivity (7 years)

  Mar 16, 2030

  in 3 yr 10 mo

• PEDPediatric exclusivity (adds 6 months)

  Sep 16, 2030

  in 4 yr 4 mo

Listed patents (20)