icosapent ethyl Oral Capsule

Brand(s)
Vascepa
Category(s)
prescription
SPL Type(s)
Human Prescription
Master SPL
Amarin Pharma Inc. (2015-06-30)
Oldest Current Product
2012-10-01
License(s)
NDA
RxNORM
ORAL CAPSULE\ICOSAPENT ETHYL
FDAOB
ORAL\CAPSULE\ICOSAPENT ETHYL
SPL Active
ORAL\CAPSULE\ICOSAPENT ETHYL
SPL Moiety
ORAL\CAPSULE\ICOSAPENT

product(s) by strength(s)

icosapent ethyl 1000 mg oral capsule

original product(s)(s)

#idbrandcategorylabelerfirst marketedactive ingredient(s)routedose formapplicationspl
1529370001VascepaNDAAmarin Pharma Inc.2012-10-01ICOSAPENT ETHYLORALCAPSULENDA2020579c1a2828-1583-4414-ab22-a60480e8e508

application(s)

#idtitleapplicantapprovedpatentapproved drug
1NDA202057VASCEPAAMARIN PHARMACEUTICALS IRELAND LTD2012-07-26p8563608, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8367652, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8188146, SUBSTANCE
p8546372, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8445003, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8318715, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8431560, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8377920, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8399446, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8551521, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8426399, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8293728, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8293727, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8524698, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8518929, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8445013, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8415335, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8314086, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8623406, METHOD OF REDUCING TG LEVELS IN PATIENT ON STATIN THERAPY SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8298554, SUBSTANCE
p8617593, METHOD OF REDUCING TG LEVELS IN PATIENT ON STATIN THERAPY SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8617594, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8501225, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8357677, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
p8440650, METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
NDA202057_001

application drug(s)

#idcategory/deprecatedingredient strength(s)routedose formrldapprovedapplication
1NDA202057_001RXICOSAPENT ETHYL (1GM)ORALCAPSULETrue2012-07-26VASCEPA

patent(s)

#idexpiration dateapplication(s)
1p8188146 (view patent)2020-01-27NDA202057
2p8293727 (view patent)2030-02-09NDA202057
3p8293728 (view patent)2030-02-09NDA202057
4p8298554 (view patent)2030-04-29NDA202057
5p8314086 (view patent)2030-02-09NDA202057
6p8318715 (view patent)2030-02-09NDA202057
7p8357677 (view patent)2030-02-09NDA202057
8p8367652 (view patent)2030-02-09NDA202057
9p8377920 (view patent)2030-02-09NDA202057
10p8399446 (view patent)2030-02-09NDA202057
11p8415335 (view patent)2030-02-09NDA202057
12p8426399 (view patent)2030-02-09NDA202057
13p8431560 (view patent)2030-02-09NDA202057
14p8440650 (view patent)2030-02-09NDA202057
15p8445003 (view patent)2030-04-29NDA202057
16p8445013 (view patent)2030-04-29NDA202057
17p8501225 (view patent)2030-04-29NDA202057
18p8518929 (view patent)2030-04-29NDA202057
19p8524698 (view patent)2030-04-29NDA202057
20p8546372 (view patent)2030-04-29NDA202057
21p8551521 (view patent)2030-04-29NDA202057
22p8563608 (view patent)2030-04-29NDA202057
23p8617593 (view patent)2030-04-29NDA202057
24p8617594 (view patent)2030-04-29NDA202057
25p8623406 (view patent)2030-04-29NDA202057

spl(s)

#idtitlecategorytypelabelerlabeler actlast updateversionproduct(s)
19c1a2828-1583-4414-ab22-a60480e8e508 (view SPL)VASCEPA (icosapent ethyl) Capsules, for oral use Initial U.S. Approval: 2012 These highlights do not include all the information needed to use VASCEPA safely and effectively. See full prescribing information for VASCEPA.prescriptionHuman PrescriptionAmarin Pharma Inc.ANALYSIS, API MANUFACTURE, MANUFACTURE, PACK2015-06-3010529370001, 529370101

Data from: FDAOB, FDAPB, LOINC, MTHSPL, NDFRT, NCIT, RxNORM, UNII