JAKAFI

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Nov 16, 2011

   14 yr 10 mo ago

2. Exclusivity ends · M-285

   New use / labeling-change exclusivity (3 years)

   Dec 19, 2025

   6 mo ago

3. Exclusivity ends · ODE-238

   Orphan-drug exclusivity (7 years)

   May 24, 2026

   26 d ago

4. Exclusivity ends · PED

   Pediatric exclusivity (adds 6 months)

   Jun 19, 2026

   today

5. Today

6. Exclusivity ends · PED

   Pediatric exclusivity (adds 6 months)

   Nov 24, 2026

   in 5 mo

7. Patent 9079912 expires

   Listed method-of-use patent (U-3226) expiration.

   Dec 12, 2026

   in 6 mo

8. Patent 9079912 expires

   Listed method-of-use patent (U-3228) expiration.

   Dec 12, 2026

   in 6 mo

9. Patent 9079912 expires

   Listed method-of-use patent (U-3227) expiration.

   Dec 12, 2026

   in 6 mo

10. Patent 9079912 expires

    Listed method-of-use patent (U-3230) expiration.

    Dec 12, 2026

    in 6 mo

11. Patent 9814722 expires

    Listed method-of-use patent (U-3226) expiration.

    Dec 12, 2026

    in 6 mo

12. Patent 9814722 expires

    Listed method-of-use patent (U-3230) expiration.

    Dec 12, 2026

    in 6 mo

13. Patent 9079912*PED expires

    Listed listed patent expiration.

    Jun 12, 2027

    in 1 yr

14. Patent 9814722*PED expires

    Listed listed patent expiration.

    Jun 12, 2027

    in 1 yr

15. Patent 7598257 expires

    Listed drug substance patent expiration.

    Dec 24, 2027

    in 1 yr 6 mo

16. Patent 7598257 expires

    Listed drug substance patent expiration.

    Dec 24, 2027

    in 1 yr 6 mo

17. Patent 8415362 expires

    Listed drug substance patent expiration.

    Dec 24, 2027

    in 1 yr 6 mo

18. Patent 10016429 expires

    Listed method-of-use patent (U-3226) expiration.

    Jun 12, 2028

    in 2 yr

19. Patent 10016429 expires

    Listed method-of-use patent (U-3230) expiration.

    Jun 12, 2028

    in 2 yr

20. Patent 8722693 expires

    Listed drug substance patent expiration.

    Jun 12, 2028

    in 2 yr

21. Patent 8822481 expires

    Listed method-of-use patent (U-1573) expiration.

    Jun 12, 2028

    in 2 yr

22. Patent 8822481 expires

    Listed method-of-use patent (U-3226) expiration.

    Jun 12, 2028

    in 2 yr

23. Patent 8822481 expires

    Listed method-of-use patent (U-3228) expiration.

    Jun 12, 2028

    in 2 yr

24. Patent 8822481 expires

    Listed method-of-use patent (U-3227) expiration.

    Jun 12, 2028

    in 2 yr

25. Patent 8822481 expires

    Listed method-of-use patent (U-3230) expiration.

    Jun 12, 2028

    in 2 yr

26. Patent 8829013 expires

    Listed method-of-use patent (U-1622) expiration.

    Jun 12, 2028

    in 2 yr

27. Patent 8829013 expires

    Listed method-of-use patent (U-1201) expiration.

    Jun 12, 2028

    in 2 yr

28. Patent 8829013 expires

    Listed method-of-use patent (U-3227) expiration.

    Jun 12, 2028

    in 2 yr

29. Patent 8829013 expires

    Listed method-of-use patent (U-3228) expiration.

    Jun 12, 2028

    in 2 yr

30. Patent 7598257*PED expires

    Listed listed patent expiration.

    Jun 24, 2028

    in 2 yr 1 mo

31. Patent 8415362*PED expires

    Listed listed patent expiration.

    Jun 24, 2028

    in 2 yr 1 mo

32. Exclusivity ends · ODE-373

    Orphan-drug exclusivity (7 years)

    Sep 22, 2028

    in 2 yr 4 mo

33. Patent 10016429*PED expires

    Listed listed patent expiration.

    Dec 12, 2028

    in 2 yr 6 mo

34. Patent 8722693*PED expires

    Listed listed patent expiration.

    Dec 12, 2028

    in 2 yr 6 mo

35. Patent 8822481*PED expires

    Listed listed patent expiration.

    Dec 12, 2028

    in 2 yr 6 mo

36. Patent 8829013*PED expires

    Listed listed patent expiration.

    Dec 12, 2028

    in 2 yr 6 mo

37. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Mar 22, 2029

    in 2 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.

• JAKAFI XRBrand (NDA)

  NDA 217180 · INCYTE CORP

  2026
• OPZELURABrand (NDA)

  NDA 215309 · INCYTE CORP

  2021

Marketing exclusivity (6)

• M-285New use / labeling-change exclusivity (3 years)

  Dec 19, 2025

  6 mo ago

• ODE-238Orphan-drug exclusivity (7 years)

  May 24, 2026

  26 d ago

• PEDPediatric exclusivity (adds 6 months)

  Jun 19, 2026

  today

• PEDPediatric exclusivity (adds 6 months)

  Nov 24, 2026

  in 5 mo

• ODE-373Orphan-drug exclusivity (7 years)

  Sep 22, 2028

  in 2 yr 4 mo

• PEDPediatric exclusivity (adds 6 months)

  Mar 22, 2029

  in 2 yr 10 mo

Listed patents (29)