TRIKAFTA (COPACKAGED)

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Jun 08, 2021

   5 yr 1 mo ago

2. Today

3. Patent 8354427 expires

   Listed method-of-use patent (U-3145) expiration.

   Jul 06, 2026

   in 17 d

4. Exclusivity ends · ODE*

   FDA marketing exclusivity

   Oct 21, 2026

   in 4 mo

5. Patent 8410274 expires

   Listed drug product patent expiration.

   Dec 28, 2026

   in 6 mo

6. Patent 8754224 expires

   Listed drug substance patent expiration.

   Dec 28, 2026

   in 6 mo

7. Patent 9670163 expires

   Listed drug product 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 9670163 expires

   Listed drug product patent expiration.

   Dec 28, 2026

   in 6 mo

10. Patent 9931334 expires

    Listed drug product patent expiration.

    Dec 28, 2026

    in 6 mo

11. Patent 9931334 expires

    Listed drug product patent expiration.

    Dec 28, 2026

    in 6 mo

12. Patent 9931334 expires

    Listed drug product patent expiration.

    Dec 28, 2026

    in 6 mo

13. Patent 10022352 expires

    Listed drug product patent expiration.

    Apr 09, 2027

    in 10 mo

14. Patent 10239867 expires

    Listed drug substance patent expiration.

    Apr 09, 2027

    in 10 mo

15. Patent 10239867 expires

    Listed drug substance patent expiration.

    Apr 09, 2027

    in 10 mo

16. Patent 10239867 expires

    Listed drug substance patent expiration.

    Apr 09, 2027

    in 10 mo

17. Patent 11639347 expires

    Listed drug substance patent expiration.

    Apr 09, 2027

    in 10 mo

18. Patent 11639347 expires

    Listed drug substance patent expiration.

    Apr 09, 2027

    in 10 mo

19. Patent 11639347 expires

    Listed drug substance patent expiration.

    Apr 09, 2027

    in 10 mo

20. Patent 9974781 expires

    Listed drug product patent expiration.

    Apr 09, 2027

    in 10 mo

21. Patent 9974781 expires

    Listed drug product patent expiration.

    Apr 09, 2027

    in 10 mo

22. Patent 9974781 expires

    Listed drug product patent expiration.

    Apr 09, 2027

    in 10 mo

23. Patent 7645789 expires

    Listed drug substance patent expiration.

    May 01, 2027

    in 11 mo

24. Patent 8598181 expires

    Listed method-of-use patent (U-3144) expiration.

    May 01, 2027

    in 11 mo

25. Patent 8598181 expires

    Listed method-of-use patent (U-4056) expiration.

    May 01, 2027

    in 11 mo

26. Patent 8598181 expires

    Listed method-of-use patent (U-4475) expiration.

    May 01, 2027

    in 11 mo

27. Patent 8623905 expires

    Listed drug substance patent expiration.

    May 01, 2027

    in 11 mo

28. Patent 7495103 expires

    Listed drug substance patent expiration.

    May 20, 2027

    in 11 mo

29. Patent 7776905 expires

    Listed drug substance patent expiration.

    Jun 03, 2027

    in 1 yr

30. Patent 8324242 expires

    Listed method-of-use patent (U-4073) expiration.

    Aug 05, 2027

    in 1 yr 2 mo

31. Patent 8324242 expires

    Listed method-of-use patent (U-3144) expiration.

    Aug 05, 2027

    in 1 yr 2 mo

32. Patent 8324242 expires

    Listed method-of-use patent (U-4475) expiration.

    Aug 05, 2027

    in 1 yr 2 mo

33. Patent 8415387 expires

    Listed method-of-use patent (U-4073) expiration.

    Nov 12, 2027

    in 1 yr 5 mo

34. Patent 8415387 expires

    Listed method-of-use patent (U-3144) expiration.

    Nov 12, 2027

    in 1 yr 5 mo

35. Patent 8415387 expires

    Listed method-of-use patent (U-4475) expiration.

    Nov 12, 2027

    in 1 yr 5 mo

36. Exclusivity ends · M-313

    New use / labeling-change exclusivity (3 years)

    Dec 20, 2027

    in 1 yr 6 mo

37. Exclusivity ends · ODE*

    FDA marketing exclusivity

    Dec 21, 2027

    in 1 yr 6 mo

38. Exclusivity ends · ODE-357

    Orphan-drug exclusivity (7 years)

    Jun 08, 2028

    in 2 yr

39. Patent 10646481 expires

    Listed drug product patent expiration.

    Aug 13, 2029

    in 3 yr 2 mo

40. Patent 11564916 expires

    Listed method-of-use patent (U-3525) expiration.

    Aug 13, 2029

    in 3 yr 2 mo

41. Patent 11564916 expires

    Listed method-of-use patent (U-4063) expiration.

    Aug 13, 2029

    in 3 yr 2 mo

42. Patent 11564916 expires

    Listed method-of-use patent (U-4491) expiration.

    Aug 13, 2029

    in 3 yr 2 mo

43. Patent 12458635 expires

    Listed drug product patent expiration.

    Aug 13, 2029

    in 3 yr 2 mo

44. Patent 12458635 expires

    Listed drug product patent expiration.

    Aug 13, 2029

    in 3 yr 2 mo

45. Patent 10081621 expires

    Listed drug product patent expiration.

    Mar 25, 2031

    in 4 yr 10 mo

46. Patent 10081621 expires

    Listed drug product patent expiration.

    Mar 25, 2031

    in 4 yr 10 mo

47. Patent 10081621 expires

    Listed drug product patent expiration.

    Mar 25, 2031

    in 4 yr 10 mo

48. Patent 11578062 expires

    Listed drug product patent expiration.

    Mar 25, 2031

    in 4 yr 10 mo

49. Patent 11578062 expires

    Listed drug product patent expiration.

    Mar 25, 2031

    in 4 yr 10 mo

50. Patent 11578062 expires

    Listed drug product patent expiration.

    Mar 25, 2031

    in 4 yr 10 mo

51. Patent RE50453 expires

    Listed drug substance patent expiration.

    Jul 10, 2031

    in 5 yr 2 mo

52. Exclusivity ends · ODE-512

    Orphan-drug exclusivity (7 years)

    Dec 20, 2031

    in 5 yr 7 mo

53. Exclusivity ends · ODE-543

    Orphan-drug exclusivity (7 years)

    Mar 27, 2033

    in 6 yr 10 mo

54. Patent 9012496 expires

    Listed method-of-use patent (U-3154) expiration.

    Jul 15, 2033

    in 7 yr 2 mo

55. Patent 10758534 expires

    Listed drug substance patent expiration.

    Oct 06, 2035

    in 9 yr 5 mo

56. Patent 10758534 expires

    Listed drug substance patent expiration.

    Oct 06, 2035

    in 9 yr 5 mo

57. Patent 10758534 expires

    Listed drug substance patent expiration.

    Oct 06, 2035

    in 9 yr 5 mo

58. Patent 11426407 expires

    Listed drug substance patent expiration.

    Oct 06, 2035

    in 9 yr 5 mo

59. Patent 11426407 expires

    Listed drug substance patent expiration.

    Oct 06, 2035

    in 9 yr 5 mo

60. Patent 11426407 expires

    Listed drug substance patent expiration.

    Oct 06, 2035

    in 9 yr 5 mo

61. Patent 10793547 expires

    Listed drug substance patent expiration.

    Dec 08, 2037

    in 11 yr 8 mo

62. Patent 10793547 expires

    Listed drug substance patent expiration.

    Dec 08, 2037

    in 11 yr 8 mo

63. Patent 10793547 expires

    Listed drug substance patent expiration.

    Dec 08, 2037

    in 11 yr 8 mo

64. Patent 11179367 expires

    Listed drug product patent expiration.

    Dec 08, 2037

    in 11 yr 8 mo

65. Patent 11179367 expires

    Listed drug product patent expiration.

    Dec 08, 2037

    in 11 yr 8 mo

66. Patent 11179367 expires

    Listed drug product patent expiration.

    Dec 08, 2037

    in 11 yr 8 mo

67. Patent 11453655 expires

    Listed drug substance patent expiration.

    Dec 08, 2037

    in 11 yr 8 mo

68. Patent 11517564 expires

    Listed drug product patent expiration.

    Dec 08, 2037

    in 11 yr 8 mo

69. Patent 11517564 expires

    Listed drug product patent expiration.

    Dec 08, 2037

    in 11 yr 8 mo

70. Patent 11517564 expires

    Listed drug product patent expiration.

    Dec 08, 2037

    in 11 yr 8 mo

71. Patent 12350262 expires

    Listed method-of-use patent (U-4222) expiration.

    Jul 17, 2038

    in 12 yr 3 mo

72. Patent 12350262 expires

    Listed method-of-use patent (U-4475) expiration.

    Jul 17, 2038

    in 12 yr 3 mo

Pharmaceutical detail

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

• TRIKAFTA (COPACKAGED)Brand (NDA)

  NDA 217660 · VERTEX PHARMS INC

  2023

Marketing exclusivity (6)

• ODE*FDA marketing exclusivity

  Oct 21, 2026

  in 4 mo

• M-313New use / labeling-change exclusivity (3 years)

  Dec 20, 2027

  in 1 yr 6 mo

• ODE*FDA marketing exclusivity

  Dec 21, 2027

  in 1 yr 6 mo

• ODE-357Orphan-drug exclusivity (7 years)

  Jun 08, 2028

  in 2 yr

• ODE-512Orphan-drug exclusivity (7 years)

  Dec 20, 2031

  in 5 yr 7 mo

• ODE-543Orphan-drug exclusivity (7 years)

  Mar 27, 2033

  in 6 yr 10 mo

Listed patents (64)