Assyro AI

Orange Book product · Brand (NDA)

VASCEPA

ICOSAPENT ETHYL

Brand (NDA)NDA 202057TE ABRX AMARIN PHARMS
View ICOSAPENT ETHYL familyOpen on FDA Orange Book

At a glance

Jul 26, 2012

Approved

Brand (NDA)

Application

AB

TE code

63

Listed patents

Key dates

  1. Approval

    FDA approval date of this drug product.

    Jul 26, 2012

    14 yr 1 mo ago

  2. Today

  3. Patent 9700537 expires

    Listed method-of-use patent (U-2707) expiration.

    May 31, 2027

    in 1 yr

  4. Patent 9198892 expires

    Listed method-of-use patent (U-2706) expiration.

    Sep 25, 2027

    in 1 yr 3 mo

  5. Patent 12171738 expires

    Listed method-of-use patent (U-4105) expiration.

    Feb 09, 2030

    in 3 yr 8 mo

  6. Patent 8415335 expires

    Listed method-of-use patent (U-1287) expiration.

    Feb 09, 2030

    in 3 yr 8 mo

  7. Patent 8426399 expires

    Listed method-of-use patent (U-1287) expiration.

    Feb 09, 2030

    in 3 yr 8 mo

  8. Patent 8518929 expires

    Listed method-of-use patent (U-1287) expiration.

    Feb 09, 2030

    in 3 yr 8 mo

  9. Patent 8524698 expires

    Listed method-of-use patent (U-1287) expiration.

    Feb 09, 2030

    in 3 yr 8 mo

  10. Patent 8546372 expires

    Listed method-of-use patent (U-1287) expiration.

    Feb 09, 2030

    in 3 yr 8 mo

  11. Patent 8680144 expires

    Listed method-of-use patent (U-2695) expiration.

    Feb 09, 2030

    in 3 yr 8 mo

  12. Patent 10010517 expires

    Listed method-of-use patent (U-2690) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  13. Patent 10265287 expires

    Listed method-of-use patent (U-2700) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  14. Patent 10792267 expires

    Listed method-of-use patent (U-2961) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  15. Patent 10842766 expires

    Listed method-of-use patent (U-2997) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  16. Patent 10881632 expires

    Listed method-of-use patent (U-3052) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  17. Patent 11103477 expires

    Listed method-of-use patent (U-3209) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  18. Patent 11154526 expires

    Listed method-of-use patent (U-3240) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  19. Patent 11213504 expires

    Listed method-of-use patent (U-3292) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  20. Patent 11717504 expires

    Listed method-of-use patent (U-3669) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  21. Patent 8298554 expires

    Listed drug product patent expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  22. Patent 8445003 expires

    Listed method-of-use patent (U-1287) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  23. Patent 8445013 expires

    Listed method-of-use patent (U-1287) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  24. Patent 8454994 expires

    Listed method-of-use patent (U-2689) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  25. Patent 8501225 expires

    Listed method-of-use patent (U-1287) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  26. Patent 8563608 expires

    Listed method-of-use patent (U-1287) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  27. Patent 8617593 expires

    Listed method-of-use patent (U-1478) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  28. Patent 8617593 expires

    Listed method-of-use patent (U-2691) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  29. Patent 8617594 expires

    Listed method-of-use patent (U-1287) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  30. Patent 8618166 expires

    Listed method-of-use patent (U-2689) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  31. Patent 8623406 expires

    Listed method-of-use patent (U-2692) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  32. Patent 8623406 expires

    Listed method-of-use patent (U-1478) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  33. Patent 8642077 expires

    Listed method-of-use patent (U-2693) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  34. Patent 8691871 expires

    Listed method-of-use patent (U-2689) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  35. Patent 8703185 expires

    Listed method-of-use patent (U-2691) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  36. Patent 8709475 expires

    Listed method-of-use patent (U-2689) expiration.

    Apr 29, 2030

    in 3 yr 11 mo

  37. Patent 10842768 expires

    Listed method-of-use patent (U-2688) expiration.

    Jun 15, 2030

    in 4 yr 1 mo

  38. Patent 8410086 expires

    Listed method-of-use patent (U-2688) expiration.

    Jun 15, 2030

    in 4 yr 1 mo

  39. Patent 8455472 expires

    Listed method-of-use patent (U-2690) expiration.

    Jun 15, 2030

    in 4 yr 1 mo

  40. Patent 8669245 expires

    Listed method-of-use patent (U-2694) expiration.

    Jun 15, 2030

    in 4 yr 1 mo

  41. Patent 8710041 expires

    Listed method-of-use patent (U-2690) expiration.

    Jun 15, 2030

    in 4 yr 1 mo

  42. Patent 10278935 expires

    Listed method-of-use patent (U-2701) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  43. Patent 10278936 expires

    Listed method-of-use patent (U-2702) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  44. Patent 10278937 expires

    Listed method-of-use patent (U-2703) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  45. Patent 10383840 expires

    Listed method-of-use patent (U-2704) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  46. Patent 10555924 expires

    Listed method-of-use patent (U-2743) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  47. Patent 10555925 expires

    Listed method-of-use patent (U-2744) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  48. Patent 10568861 expires

    Listed method-of-use patent (U-2756) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  49. Patent 10576054 expires

    Listed method-of-use patent (U-2762) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  50. Patent 10668042 expires

    Listed method-of-use patent (U-2841) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  51. Patent 10786478 expires

    Listed method-of-use patent (U-2959) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  52. Patent 10786478 expires

    Listed method-of-use patent (U-2960) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  53. Patent 10792270 expires

    Listed method-of-use patent (U-2962) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  54. Patent 10894028 expires

    Listed method-of-use patent (U-3053) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  55. Patent 11000499 expires

    Listed method-of-use patent (U-3126) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  56. Patent 11116742 expires

    Listed method-of-use patent (U-3221) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  57. Patent 11298333 expires

    Listed method-of-use patent (U-3358) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  58. Patent 11369582 expires

    Listed method-of-use patent (U-2841) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  59. Patent 9603826 expires

    Listed method-of-use patent (U-2696) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  60. Patent 9610272 expires

    Listed method-of-use patent (U-2697) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  61. Patent 9623001 expires

    Listed method-of-use patent (U-2698) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  62. Patent 9693984 expires

    Listed method-of-use patent (U-2697) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  63. Patent 9693985 expires

    Listed method-of-use patent (U-2696) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  64. Patent 9693986 expires

    Listed method-of-use patent (U-2698) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

  65. Patent 9918954 expires

    Listed method-of-use patent (U-2699) expiration.

    Jun 28, 2033

    in 7 yr 2 mo

Pharmaceutical detail

Active ingredient

ICOSAPENT ETHYL

Strength

1GM

Dosage form

CAPSULE

Route

ORAL

TE code

AB

Application

NDA 202057

Product number

001

Marketing status

RX

Reference listed drug (RLD)

Yes

Reference standard (RS)

Yes

Active-ingredient family

View full family

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

Listed patents (63)

Patents listed in the FDA Orange Book for this product, with expiration date and patent type.
PatentExpiresInType
9700537May 31, 2027in 1 yr
U-2707
9198892Sep 25, 2027in 1 yr 3 mo
U-2706
12171738Feb 09, 2030in 3 yr 8 mo
U-4105
8415335Feb 09, 2030in 3 yr 8 mo
U-1287
8426399Feb 09, 2030in 3 yr 8 mo
U-1287
8518929Feb 09, 2030in 3 yr 8 mo
U-1287
8524698Feb 09, 2030in 3 yr 8 mo
U-1287
8546372Feb 09, 2030in 3 yr 8 mo
U-1287
8680144Feb 09, 2030in 3 yr 8 mo
U-2695
10010517Apr 29, 2030in 3 yr 11 mo
U-2690
10265287Apr 29, 2030in 3 yr 11 mo
U-2700
10792267Apr 29, 2030in 3 yr 11 mo
U-2961
10842766Apr 29, 2030in 3 yr 11 mo
U-2997
10881632Apr 29, 2030in 3 yr 11 mo
U-3052
11103477Apr 29, 2030in 3 yr 11 mo
U-3209
11154526Apr 29, 2030in 3 yr 11 mo
U-3240
11213504Apr 29, 2030in 3 yr 11 mo
U-3292
11717504Apr 29, 2030in 3 yr 11 mo
U-3669
8298554Apr 29, 2030in 3 yr 11 mo
Product
8445003Apr 29, 2030in 3 yr 11 mo
U-1287
8445013Apr 29, 2030in 3 yr 11 mo
U-1287
8454994Apr 29, 2030in 3 yr 11 mo
U-2689
8501225Apr 29, 2030in 3 yr 11 mo
U-1287
8563608Apr 29, 2030in 3 yr 11 mo
U-1287
8617593Apr 29, 2030in 3 yr 11 mo
U-1478
8617593Apr 29, 2030in 3 yr 11 mo
U-2691
8617594Apr 29, 2030in 3 yr 11 mo
U-1287
8618166Apr 29, 2030in 3 yr 11 mo
U-2689
8623406Apr 29, 2030in 3 yr 11 mo
U-2692
8623406Apr 29, 2030in 3 yr 11 mo
U-1478
8642077Apr 29, 2030in 3 yr 11 mo
U-2693
8691871Apr 29, 2030in 3 yr 11 mo
U-2689
8703185Apr 29, 2030in 3 yr 11 mo
U-2691
8709475Apr 29, 2030in 3 yr 11 mo
U-2689
10842768Jun 15, 2030in 4 yr 1 mo
U-2688
8410086Jun 15, 2030in 4 yr 1 mo
U-2688
8455472Jun 15, 2030in 4 yr 1 mo
U-2690
8669245Jun 15, 2030in 4 yr 1 mo
U-2694
8710041Jun 15, 2030in 4 yr 1 mo
U-2690
10278935Jun 28, 2033in 7 yr 2 mo
U-2701
10278936Jun 28, 2033in 7 yr 2 mo
U-2702
10278937Jun 28, 2033in 7 yr 2 mo
U-2703
10383840Jun 28, 2033in 7 yr 2 mo
U-2704
10555924Jun 28, 2033in 7 yr 2 mo
U-2743
10555925Jun 28, 2033in 7 yr 2 mo
U-2744
10568861Jun 28, 2033in 7 yr 2 mo
U-2756
10576054Jun 28, 2033in 7 yr 2 mo
U-2762
10668042Jun 28, 2033in 7 yr 2 mo
U-2841
10786478Jun 28, 2033in 7 yr 2 mo
U-2959
10786478Jun 28, 2033in 7 yr 2 mo
U-2960
10792270Jun 28, 2033in 7 yr 2 mo
U-2962
10894028Jun 28, 2033in 7 yr 2 mo
U-3053
11000499Jun 28, 2033in 7 yr 2 mo
U-3126
11116742Jun 28, 2033in 7 yr 2 mo
U-3221
11298333Jun 28, 2033in 7 yr 2 mo
U-3358
11369582Jun 28, 2033in 7 yr 2 mo
U-2841
9603826Jun 28, 2033in 7 yr 2 mo
U-2696
9610272Jun 28, 2033in 7 yr 2 mo
U-2697
9623001Jun 28, 2033in 7 yr 2 mo
U-2698
9693984Jun 28, 2033in 7 yr 2 mo
U-2697
9693985Jun 28, 2033in 7 yr 2 mo
U-2696
9693986Jun 28, 2033in 7 yr 2 mo
U-2698
9918954Jun 28, 2033in 7 yr 2 mo
U-2699
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