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FDA Orange Book · active-ingredient family

Icosapent ethyl

Icosapent ethyl is approved as 1 brand and 11 generic applications in the FDA Orange Book, with their therapeutic-equivalence codes, listed patents, and marketing exclusivity.

Reference-listed drug:VASCEPA · NDA 202057

1

Brand (NDA)

11

Generics (ANDA)

61

Listed patents

0

Exclusivity periods

Brand (NDA) products · capsule

ProductApplicantApplicationTEApproved
VASCEPARLD×2AMARIN PHARMSNDA 202057ABJul 26, 2012

Generic (ANDA) products (11)

ProductApplicantApplicationTEApproved
ICOSAPENT ETHYLXIAMEN LP PHARM COANDA 219156ABAug 06, 2025
ICOSAPENT ETHYLTORRENTANDA 218994ABDec 20, 2024
ICOSAPENT ETHYLQILUANDA 218899ABNov 20, 2024
ICOSAPENT ETHYL×2ASCENT PHARMS INCANDA 216811ABFeb 16, 2024
ICOSAPENT ETHYL×2HUMANWELL PURACAPANDA 217919ABDec 22, 2023
ICOSAPENT ETHYL×2ONESOURCE SPECIALTYANDA 217844ABSep 22, 2023
ICOSAPENT ETHYL×2ZYDUS LIFESCIENCESANDA 217656ABApr 20, 2023
ICOSAPENT ETHYLAPOTEXANDA 209437ABJun 30, 2021
ICOSAPENT ETHYL×2TEVA PHARMS USAANDA 209525ABSep 11, 2020
ICOSAPENT ETHYL×2DR REDDYSANDA 209499ABAug 07, 2020
ICOSAPENT ETHYL×2HIKMAANDA 209457ABMay 21, 2020

Listed patents (61)

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
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
8426399Feb 09, 2030in 3 yr 8 mo
U-1287
12171738Feb 09, 2030in 3 yr 8 mo
U-4105
8415335Feb 09, 2030in 3 yr 8 mo
U-1287
8518929Feb 09, 2030in 3 yr 8 mo
U-1287
8399446Feb 09, 2030in 3 yr 8 mo
U-1287
8501225Apr 29, 2030in 3 yr 11 mo
U-1287
8617593Apr 29, 2030in 3 yr 11 mo
U-1478
8617594Apr 29, 2030in 3 yr 11 mo
U-1287
8445003Apr 29, 2030in 3 yr 11 mo
U-1287
8454994Apr 29, 2030in 3 yr 11 mo
U-2689
8618166Apr 29, 2030in 3 yr 11 mo
U-2689
8623406Apr 29, 2030in 3 yr 11 mo
U-2692
8642077Apr 29, 2030in 3 yr 11 mo
U-2693
8703185Apr 29, 2030in 3 yr 11 mo
U-2691
8691871Apr 29, 2030in 3 yr 11 mo
U-2689
8709475Apr 29, 2030in 3 yr 11 mo
U-2689
10010517Apr 29, 2030in 3 yr 11 mo
U-2690
10265287Apr 29, 2030in 3 yr 11 mo
U-2700
8563608Apr 29, 2030in 3 yr 11 mo
U-1287
11154526Apr 29, 2030in 3 yr 11 mo
U-3240
11717504Apr 29, 2030in 3 yr 11 mo
U-3669
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
8445013Apr 29, 2030in 3 yr 11 mo
U-1287
11213504Apr 29, 2030in 3 yr 11 mo
U-3292
8298554Apr 29, 2030in 3 yr 11 mo
Product
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
10842768Jun 15, 2030in 4 yr 1 mo
U-2688
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
10278935Jun 28, 2033in 7 yr 2 mo
U-2701
10278937Jun 28, 2033in 7 yr 2 mo
U-2703
10278936Jun 28, 2033in 7 yr 2 mo
U-2702
10383840Jun 28, 2033in 7 yr 2 mo
U-2704
10555925Jun 28, 2033in 7 yr 2 mo
U-2744
10555924Jun 28, 2033in 7 yr 2 mo
U-2743
11369582Jun 28, 2033in 7 yr 2 mo
U-2841
11298333Jun 28, 2033in 7 yr 2 mo
U-3358
10568861Jun 28, 2033in 7 yr 2 mo
U-2756
10668042Jun 28, 2033in 7 yr 2 mo
U-2841
10576054Jun 28, 2033in 7 yr 2 mo
U-2762
10792270Jun 28, 2033in 7 yr 2 mo
U-2962
10786478Jun 28, 2033in 7 yr 2 mo
U-2959
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

Icosapent ethyl — frequently asked questions

Generics, reference-listed drug, patents, and exclusivity for this active ingredient, from the FDA Orange Book.

Agent CTA Background

Your Next Submission Could Take 6+ Fewer Weeks and Cost $250K Less.

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