TAFINLAR

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 9233956 expires

   Listed method-of-use patent (U-1811) expiration.

   May 04, 2029

   in 2 yr 11 mo

6. Patent 9233956 expires

   Listed method-of-use patent (U-2296) expiration.

   May 04, 2029

   in 2 yr 11 mo

7. Patent 9233956 expires

   Listed method-of-use patent (U-2031) expiration.

   May 04, 2029

   in 2 yr 11 mo

8. Patent 9233956 expires

   Listed method-of-use patent (U-2032) expiration.

   May 04, 2029

   in 2 yr 11 mo

9. Patent 9233956*PED expires

   Listed listed patent expiration.

   Nov 04, 2029

   in 3 yr 5 mo

10. Patent 7994185 expires

    Listed drug substance patent expiration.

    Jan 20, 2030

    in 3 yr 8 mo

11. Patent 7994185 expires

    Listed drug substance patent expiration.

    Jan 20, 2030

    in 3 yr 8 mo

12. Patent 7994185 expires

    Listed drug substance patent expiration.

    Jan 20, 2030

    in 3 yr 8 mo

13. Patent 7994185 expires

    Listed drug substance patent expiration.

    Jan 20, 2030

    in 3 yr 8 mo

14. Patent 8415345 expires

    Listed drug substance patent expiration.

    Jan 20, 2030

    in 3 yr 8 mo

15. Patent 8415345 expires

    Listed drug substance patent expiration.

    Jan 20, 2030

    in 3 yr 8 mo

16. Patent 8415345 expires

    Listed drug substance patent expiration.

    Jan 20, 2030

    in 3 yr 8 mo

17. Patent 8415345 expires

    Listed drug substance patent expiration.

    Jan 20, 2030

    in 3 yr 8 mo

18. Exclusivity ends · ODE-428

    Orphan-drug exclusivity (7 years)

    Mar 16, 2030

    in 3 yr 10 mo

19. Patent 7994185*PED expires

    Listed listed patent expiration.

    Jul 20, 2030

    in 4 yr 2 mo

20. Patent 8415345*PED expires

    Listed listed patent expiration.

    Jul 20, 2030

    in 4 yr 2 mo

21. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Sep 16, 2030

    in 4 yr 4 mo

22. Patent 8703781 expires

    Listed drug substance patent expiration.

    Oct 15, 2030

    in 4 yr 5 mo

23. Patent 8703781 expires

    Listed drug substance patent expiration.

    Oct 15, 2030

    in 4 yr 5 mo

24. Patent 8703781 expires

    Listed drug substance patent expiration.

    Oct 15, 2030

    in 4 yr 5 mo

25. Patent 8703781 expires

    Listed drug substance patent expiration.

    Oct 15, 2030

    in 4 yr 5 mo

26. Patent 8952018 expires

    Listed method-of-use patent (U-2027) expiration.

    Oct 15, 2030

    in 4 yr 5 mo

27. Patent 8703781*PED expires

    Listed listed patent expiration.

    Apr 15, 2031

    in 4 yr 11 mo

28. Patent 8952018*PED expires

    Listed listed patent expiration.

    Apr 15, 2031

    in 4 yr 11 mo

29. Patent 10869869 expires

    Listed method-of-use patent (U-3185) expiration.

    Aug 30, 2033

    in 7 yr 4 mo

30. 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.

• TAFINLARBrand (NDA)

  NDA 217514 · NOVARTIS

  2023

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 (24)