EPIDIOLEX

At a glance

Key dates

1. Approval

   FDA approval date of this drug product.

   Sep 28, 2018

   7 yr 10 mo ago

2. Today

3. Exclusivity ends · M-270

   New use / labeling-change exclusivity (3 years)

   Oct 20, 2026

   in 4 mo

4. Exclusivity ends · ODE-326

   Orphan-drug exclusivity (7 years)

   Jul 31, 2027

   in 1 yr 2 mo

5. Exclusivity ends · ODE-332

   Orphan-drug exclusivity (7 years)

   Jul 31, 2027

   in 1 yr 2 mo

6. Patent 10092525 expires

   Listed method-of-use patent (U-2427) expiration.

   Jun 17, 2035

   in 9 yr 2 mo

7. Patent 10111840 expires

   Listed method-of-use patent (U-2443) expiration.

   Jun 17, 2035

   in 9 yr 2 mo

8. Patent 10111840 expires

   Listed method-of-use patent (U-2442) expiration.

   Jun 17, 2035

   in 9 yr 2 mo

9. Patent 10137095 expires

   Listed method-of-use patent (U-2454) expiration.

   Jun 17, 2035

   in 9 yr 2 mo

10. Patent 10137095 expires

    Listed method-of-use patent (U-2455) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

11. Patent 10603288 expires

    Listed method-of-use patent (U-2780) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

12. Patent 10603288 expires

    Listed method-of-use patent (U-2781) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

13. Patent 10603288 expires

    Listed method-of-use patent (U-2782) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

14. Patent 10603288 expires

    Listed method-of-use patent (U-2783) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

15. Patent 10709671 expires

    Listed method-of-use patent (U-2862) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

16. Patent 10709673 expires

    Listed drug product patent expiration.

    Jun 17, 2035

    in 9 yr 2 mo

17. Patent 10709674 expires

    Listed method-of-use patent (U-2781) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

18. Patent 10709674 expires

    Listed method-of-use patent (U-2780) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

19. Patent 10849860 expires

    Listed method-of-use patent (U-2427) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

20. Patent 10849860 expires

    Listed method-of-use patent (U-2454) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

21. Patent 10966939 expires

    Listed drug product patent expiration.

    Jun 17, 2035

    in 9 yr 2 mo

22. Patent 10966939 expires

    Listed drug product patent expiration.

    Jun 17, 2035

    in 9 yr 2 mo

23. Patent 11154516 expires

    Listed method-of-use patent (U-3235) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

24. Patent 11154516 expires

    Listed method-of-use patent (U-3236) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

25. Patent 11311498 expires

    Listed method-of-use patent (U-3375) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

26. Patent 11311498 expires

    Listed method-of-use patent (U-3376) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

27. Patent 11357741 expires

    Listed method-of-use patent (U-2862) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

28. Patent 11446258 expires

    Listed method-of-use patent (U-2780) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

29. Patent 11446258 expires

    Listed method-of-use patent (U-2781) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

30. Patent 11446258 expires

    Listed method-of-use patent (U-3071) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

31. Patent 11633369 expires

    Listed drug product patent expiration.

    Jun 17, 2035

    in 9 yr 2 mo

32. Patent 11633369 expires

    Listed drug product patent expiration.

    Jun 17, 2035

    in 9 yr 2 mo

33. Patent 11633369 expires

    Listed drug product patent expiration.

    Jun 17, 2035

    in 9 yr 2 mo

34. Patent 11701330 expires

    Listed method-of-use patent (U-2780) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

35. Patent 11701330 expires

    Listed method-of-use patent (U-2781) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

36. Patent 11766411 expires

    Listed method-of-use patent (U-2781) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

37. Patent 11963937 expires

    Listed method-of-use patent (U-2780) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

38. Patent 11963937 expires

    Listed method-of-use patent (U-2781) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

39. Patent 12064399 expires

    Listed method-of-use patent (U-3988) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

40. Patent 12064399 expires

    Listed method-of-use patent (U-3989) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

41. Patent 9949937 expires

    Listed method-of-use patent (U-2421) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

42. Patent 9956183 expires

    Listed method-of-use patent (U-2422) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

43. Patent 9956183 expires

    Listed method-of-use patent (U-2423) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

44. Patent 9956184 expires

    Listed method-of-use patent (U-2424) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

45. Patent 9956185 expires

    Listed method-of-use patent (U-2425) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

46. Patent 9956186 expires

    Listed method-of-use patent (U-2426) expiration.

    Jun 17, 2035

    in 9 yr 2 mo

47. Patent 10918608 expires

    Listed method-of-use patent (U-3072) expiration.

    Oct 13, 2035

    in 9 yr 5 mo

48. Patent 10918608 expires

    Listed method-of-use patent (U-3071) expiration.

    Oct 13, 2035

    in 9 yr 5 mo

49. Patent 10918608 expires

    Listed method-of-use patent (U-3073) expiration.

    Oct 13, 2035

    in 9 yr 5 mo

50. Patent 11065209 expires

    Listed method-of-use patent (U-3071) expiration.

    Oct 13, 2035

    in 9 yr 5 mo

51. Patent 11096905 expires

    Listed drug substance patent expiration.

    Oct 13, 2035

    in 9 yr 5 mo

52. Patent 11096905 expires

    Listed drug substance patent expiration.

    Oct 13, 2035

    in 9 yr 5 mo

53. Patent 11400055 expires

    Listed method-of-use patent (U-3071) expiration.

    Oct 13, 2035

    in 9 yr 5 mo

54. Patent 11207292 expires

    Listed drug substance patent expiration.

    Apr 26, 2039

    in 13 yr

55. Patent 11207292 expires

    Listed drug substance patent expiration.

    Apr 26, 2039

    in 13 yr

56. Patent 11207292 expires

    Listed drug substance patent expiration.

    Apr 26, 2039

    in 13 yr

57. Patent 11865102 expires

    Listed drug substance patent expiration.

    Apr 26, 2039

    in 13 yr

58. Patent 11865102 expires

    Listed drug substance patent expiration.

    Apr 26, 2039

    in 13 yr

59. Patent 11865102 expires

    Listed drug substance patent expiration.

    Apr 26, 2039

    in 13 yr

60. Patent 11160795 expires

    Listed method-of-use patent (U-3233) expiration.

    Mar 01, 2041

    in 14 yr 11 mo

61. Patent 11406623 expires

    Listed method-of-use patent (U-3233) expiration.

    Mar 01, 2041

    in 14 yr 11 mo

62. Patent 12102619 expires

    Listed method-of-use patent (U-3233) expiration.

    Mar 01, 2041

    in 14 yr 11 mo

Pharmaceutical detail

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

Marketing exclusivity (3)

• M-270New use / labeling-change exclusivity (3 years)

  Oct 20, 2026

  in 4 mo

• ODE-326Orphan-drug exclusivity (7 years)

  Jul 31, 2027

  in 1 yr 2 mo

• ODE-332Orphan-drug exclusivity (7 years)

  Jul 31, 2027

  in 1 yr 2 mo

Listed patents (57)