ORKAMBI

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Aug 07, 2018

   8 yr ago

2. Today

3. Patent 7973038 expires

   Listed method-of-use patent (U-2374) expiration.

   Nov 08, 2026

   in 5 mo

4. Patent 8741933 expires

   Listed method-of-use patent (U-2374) expiration.

   Nov 08, 2026

   in 5 mo

5. Patent 9216969 expires

   Listed drug product patent expiration.

   Nov 08, 2026

   in 5 mo

6. Patent 8410274 expires

   Listed drug product patent expiration.

   Dec 28, 2026

   in 6 mo

7. Patent 8754224 expires

   Listed drug substance patent expiration.

   Dec 28, 2026

   in 6 mo

8. Patent 9670163 expires

   Listed drug product patent expiration.

   Dec 28, 2026

   in 6 mo

9. Patent 9931334 expires

   Listed drug product patent expiration.

   Dec 28, 2026

   in 6 mo

10. Patent 7973038*PED expires

    Listed listed patent expiration.

    May 08, 2027

    in 11 mo

11. Patent 8741933*PED expires

    Listed listed patent expiration.

    May 08, 2027

    in 11 mo

12. Patent 9216969*PED expires

    Listed listed patent expiration.

    May 08, 2027

    in 11 mo

13. Patent 7495103 expires

    Listed drug substance patent expiration.

    May 20, 2027

    in 11 mo

14. Patent 8410274*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

15. Patent 8754224*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

16. Patent 9670163*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

17. Patent 9931334*PED expires

    Listed listed patent expiration.

    Jun 28, 2027

    in 1 yr

18. Patent 8324242 expires

    Listed method-of-use patent (U-2374) expiration.

    Aug 05, 2027

    in 1 yr 2 mo

19. Patent 7495103*PED expires

    Listed listed patent expiration.

    Nov 20, 2027

    in 1 yr 5 mo

20. Exclusivity ends · M-14

    New use / labeling-change exclusivity (3 years)

    Dec 13, 2027

    in 1 yr 6 mo

21. Patent 8324242*PED expires

    Listed listed patent expiration.

    Feb 05, 2028

    in 1 yr 8 mo

22. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Jun 13, 2028

    in 2 yr

23. Patent 10597384 expires

    Listed drug substance patent expiration.

    Dec 04, 2028

    in 2 yr 6 mo

24. Patent 12065432 expires

    Listed method-of-use patent (U-3983) expiration.

    Dec 04, 2028

    in 2 yr 6 mo

25. Patent 8653103 expires

    Listed drug product patent expiration.

    Dec 04, 2028

    in 2 yr 6 mo

26. Patent 9150552 expires

    Listed method-of-use patent (U-2375) expiration.

    Dec 04, 2028

    in 2 yr 6 mo

27. Patent 10597384*PED expires

    Listed listed patent expiration.

    Jun 04, 2029

    in 3 yr

28. Patent 12065432*PED expires

    Listed listed patent expiration.

    Jun 04, 2029

    in 3 yr

29. Patent 8653103*PED expires

    Listed listed patent expiration.

    Jun 04, 2029

    in 3 yr

30. Patent 9150552*PED expires

    Listed listed patent expiration.

    Jun 04, 2029

    in 3 yr

31. Patent 8846718 expires

    Listed method-of-use patent (U-2375) expiration.

    Jul 02, 2029

    in 3 yr 1 mo

32. Patent 10646481 expires

    Listed drug product patent expiration.

    Aug 13, 2029

    in 3 yr 2 mo

33. Patent 11564916 expires

    Listed method-of-use patent (U-3526) expiration.

    Aug 13, 2029

    in 3 yr 2 mo

34. Patent 12458635 expires

    Listed drug product patent expiration.

    Aug 13, 2029

    in 3 yr 2 mo

35. Exclusivity ends · ODE-408

    Orphan-drug exclusivity (7 years)

    Sep 02, 2029

    in 3 yr 3 mo

36. Patent 9192606 expires

    Listed drug product patent expiration.

    Sep 29, 2029

    in 3 yr 4 mo

37. Patent 8846718*PED expires

    Listed listed patent expiration.

    Jan 02, 2030

    in 3 yr 7 mo

38. Patent 10646481*PED expires

    Listed listed patent expiration.

    Feb 13, 2030

    in 3 yr 9 mo

39. Patent 11564916*PED expires

    Listed listed patent expiration.

    Feb 13, 2030

    in 3 yr 9 mo

40. Patent 12458635*PED expires

    Listed listed patent expiration.

    Feb 13, 2030

    in 3 yr 9 mo

41. Exclusivity ends · PED

    Pediatric exclusivity (adds 6 months)

    Mar 02, 2030

    in 3 yr 9 mo

42. Patent 9192606*PED expires

    Listed listed patent expiration.

    Mar 29, 2030

    in 3 yr 10 mo

43. Patent 8507534 expires

    Listed drug substance patent expiration.

    Sep 20, 2030

    in 4 yr 4 mo

44. Patent 8716338 expires

    Listed drug product patent expiration.

    Sep 20, 2030

    in 4 yr 4 mo

45. Patent 8993600 expires

    Listed drug product patent expiration.

    Dec 11, 2030

    in 4 yr 7 mo

46. Patent 8507534*PED expires

    Listed listed patent expiration.

    Mar 20, 2031

    in 4 yr 10 mo

47. Patent 8716338*PED expires

    Listed listed patent expiration.

    Mar 20, 2031

    in 4 yr 10 mo

48. Patent 8993600*PED expires

    Listed listed patent expiration.

    Jun 11, 2031

    in 5 yr 1 mo

Pharmaceutical detail

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

• ORKAMBIBrand (NDA)

  NDA 206038 · VERTEX PHARMS INC

  2016

Marketing exclusivity (4)

• M-14New use / labeling-change exclusivity (3 years)

  Dec 13, 2027

  in 1 yr 6 mo

• PEDPediatric exclusivity (adds 6 months)

  Jun 13, 2028

  in 2 yr

• ODE-408Orphan-drug exclusivity (7 years)

  Sep 02, 2029

  in 3 yr 3 mo

• PEDPediatric exclusivity (adds 6 months)

  Mar 02, 2030

  in 3 yr 9 mo

Listed patents (42)