icosapent ethyl 🐶 Veterinary Use | Indications/Contra | FAERs-F | FAERs-M | Orange Bk | BioActivity |

Stem definitionDrug idCAS RN
1413 86227-47-6

Description:

MoleculeDescription

Molfile Inchi Smiles

Synonyms:

  • ethyl-eicosapent
  • ethyl eicosapent
  • ethyl-eicosapentaenoic acid
  • icosapent ethyl
  • vascepa
  • ethyl eicosapentaenoate
  • ethyl icosapentate
  • timnodonic acid ethyl ester
Icosapent ethyl is a stable ethyl ester of the omega-3 fatty acid, eicosapentaenoic acid (EPA). The mechanisms of action contributing to reduction of cardiovascular events with icosapent ethyl are not completely understood. The mechanisms are likely multi-factorial including improved lipoprotein profile with reduction of triglyceride-rich lipoproteins, anti-inflammatory, and antioxidant effects, reduction of macrophage accumulation, improved endothelial function, increased fibrous cap thickness/stability, and antiplatelet effects. Each of these mechanisms can beneficially alter the development, progression, and stabilisation of atherosclerotic plaque, as well as the implications of plaque rupture, and preclinical and clinical studies support such benefits with EPA. Systemic and localised anti-inflammatory effects of EPA may result from displacement of pro-inflammatory arachidonic acid (AA), directing catabolism away from eicosanoids (2-series prostaglandins and thromboxanes, and 4-series leukotrienes) to non- or anti-inflammatory mediators. However, the direct clinical meaning of individual findings is not clear.
  • Molecular weight: 330.51
  • Formula: C22H34O2
  • CLOGP: 7.81
  • LIPINSKI: 1
  • HAC: 2
  • HDO: 0
  • TPSA: 26.30
  • ALOGS: -6.53
  • ROTB: 15

  • Status: OFP

  • Legend:
    OFP - off patent
    OFM - off market
    ONP - on patent

Drug dosage:

None

ADMET properties:

None

Approvals:

DateAgencyCompanyOrphan
March 26, 2021 EMA Amarin Pharmaceuticals Ireland Limited
July 26, 2012 FDA AMARIN PHARMS

FDA Adverse Event Reporting System (Female)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Product odour abnormal 143.75 22.99 26 1774 1051 50602273
Product physical issue 63.19 22.99 17 1783 4315 50599009
Prescribed underdose 51.93 22.99 20 1780 15929 50587395
Blood triglycerides increased 47.12 22.99 17 1783 11295 50592029
Product taste abnormal 40.91 22.99 10 1790 1735 50601589
Eructation 34.59 22.99 12 1788 7109 50596215
Intentional underdose 26.66 22.99 7 1793 1615 50601709
Product adhesion issue 23.66 22.99 8 1792 4384 50598940

FDA Adverse Event Reporting System (Male)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Product odour abnormal 289.59 23.27 49 2152 616 29571710
Product taste abnormal 102.34 23.27 22 2179 1025 29571301
Product physical issue 102.31 23.27 25 2176 2063 29570263
Blood triglycerides increased 92.26 23.27 35 2166 12799 29559527
Prescribed underdose 73.63 23.27 26 2175 7760 29564566
Product adhesion issue 44.51 23.27 12 2189 1459 29570867
Eructation 44.12 23.27 15 2186 3991 29568335
Blood triglycerides abnormal 42.61 23.27 8 2193 185 29572141
Hyperkinetic heart syndrome 39.79 23.27 7 2194 111 29572215
Cerebral infarction 29.67 23.27 20 2181 24655 29547671
Echocardiogram abnormal 25.85 23.27 7 2194 864 29571462
Erythema multiforme 25.08 23.27 12 2189 7705 29564621

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event termLikelihood ratioLikelihood ratio thresholdPatients taking drug having adverse eventPatients taking drug not having adverse eventPatients not taking drug having adverse eventPatients not taking drug not having adverse event
Product odour abnormal 233.30 21.54 42 3328 1111 64494251
Product physical issue 98.59 21.54 25 3345 3424 64491938
Product taste abnormal 90.50 21.54 21 3349 1982 64493380
Blood triglycerides increased 70.17 21.54 29 3341 18837 64476525
Product adhesion issue 61.36 21.54 16 3354 2443 64492919
Prescribed underdose 58.01 21.54 25 3345 17990 64477372
Cerebral infarction 54.07 21.54 31 3339 41013 64454349
Hyperkinetic heart syndrome 41.69 21.54 7 3363 121 64495241
Eructation 40.61 21.54 16 3354 9175 64486187
Renal impairment 29.85 21.54 36 3334 134981 64360381
Blood triglycerides abnormal 28.62 21.54 6 3364 354 64495008
Hepatic function abnormal 24.66 21.54 23 3347 64290 64431072
Erythema multiforme 23.76 21.54 13 3357 15688 64479674
Echocardiogram abnormal 23.31 21.54 7 3363 1782 64493580

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

SourceCodeDescription
MeSH PA D006401 Hematologic Agents
MeSH PA D057847 Lipid Regulating Agents
MeSH PA D010975 Platelet Aggregation Inhibitors
CHEBI has role CHEBI:35469 antidepressants
CHEBI has role CHEBI:35476 neuroleptics
CHEBI has role CHEBI:35821 anticholesteremic drugs
CHEBI has role CHEBI:50266 Prodrugs
CHEBI has role CHEBI:76507 marine metabolites

Drug Use (View source of the data)

DiseaseRelationSNOMED_IDDOID
Hypertriglyceridemia indication 302870006




🐶 Veterinary Drug Use

None

🐶 Veterinary products

None

Acid dissociation constants calculated using MoKa v3.0.0

None

Orange Book patent data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRoutePatent numberPatent expiration datePatent use
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 9700537 May 31, 2027 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE OCCURRENCE OF A CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH HYPERCHOLESTEROLEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 9700537 May 31, 2027 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE OCCURRENCE OF A CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH HYPERCHOLESTEROLEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 9198892 Sept. 25, 2027 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF ONSET AND/OR RECURRENCE OF CARDIOVASCULAR EVENTS IN A PATIENT WHO HAS ESCAPED THE UNSTABLE PERIOD AFTER CARDIOVASCULAR ANGIOPLASTY
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 9198892 Sept. 25, 2027 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF ONSET AND/OR RECURRENCE OF CARDIOVASCULAR EVENTS IN A PATIENT WHO HAS ESCAPED THE UNSTABLE PERIOD AFTER CARDIOVASCULAR ANGIOPLASTY
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8293727 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8293728 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8314086 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8318715 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8357677 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8367652 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8377920 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8399446 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8415335 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8426399 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8431560 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8440650 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8518929 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8524698 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8546372 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8680144 Feb. 9, 2030 USE OF VASCEPA TO TREAT MIXED HYPERTRIGLYCERIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8293727 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8293728 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8314086 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8318715 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8357677 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8367652 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8377920 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8399446 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8415335 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8426399 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8440650 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8518929 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8524698 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8546372 Feb. 9, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8680144 Feb. 9, 2030 USE OF VASCEPA TO TREAT MIXED HYPERTRIGLYCERIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10010517 April 29, 2030 USE OF VASCEPA TO LOWER TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10265287 April 29, 2030 USE OF VASCEPA TO REDUCE TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON ROSUVASTATIN THERAPY
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10792267 April 29, 2030 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF MYOCARDIAL INFARCTION, STROKE, BOTH IN AN ADULT PATIENT WITH TYPE 2 DIABETES MELLITUS
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10842766 April 29, 2030 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF STROKE IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDES AND ATRIAL FIBRILLATION
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10881632 April 29, 2030 USE OF VASCEPA TO REDUCE TRIGLYCERIDE LEVELS IN AN ADULT PATIENT ON STATIN THERAPY AND HAVING ATRIAL FIBRILLATION AND TRIGLYCERIDE LEVELS OF GREATER THAN 500 MG/DL
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 11103477 April 29, 2030 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK MYOCARDIAL INFARCTION IN AN ADULT PATIENT HAVING ATRIAL FIBRILLATION OR ATRIAL FLUTTER AND ELEVATED TRIGLYCERIDE LEVELS
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 11154526 April 29, 2030 USE OF VASCEPA TO REDUCE TRIGLYCERIDE LEVELS IN AN ADULT PATIENT HAVING TRIGLYCERIDE LEVELS OF AT LEAST ABOUT 500 MG/DL, ON ANTICOAGULANT/ANTIPLATELET/THROMBOLYTIC THERAPY, AND HAVING ATRIAL FIBRILLATION AND/OR ATRIAL FLUTTER
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 11213504 April 29, 2030 USE OF VASCEPA TO REDUCE TRIGLYCERIDE LEVELS IN AN ADULT PATIENT ON STATIN THERAPY AND HAVING ATRIAL FIBRILLATION OR ATRIAL FLUTTER AND TRIGLYCERIDE LEVELS OF ABOUT 500 MG/DL TO ABOUT 2,000 MG/DL
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8445003 April 29, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8445013 April 29, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8454994 April 29, 2030 USE OF VASCEPA TO TREAT MIXED DYSLIPIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>=150 MG/DL) AND ON STATIN THERAPY
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8501225 April 29, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8551521 April 29, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8563608 April 29, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8617593 April 29, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT ON STATIN THERAPY SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8617593 April 29, 2030 USE OF VASCEPA TO TREAT HYPERTRIGLYCERIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8617594 April 29, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8618166 April 29, 2030 USE OF VASCEPA TO TREAT MIXED DYSLIPIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>=150 MG/DL) AND ON STATIN THERAPY
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8623406 April 29, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT ON STATIN THERAPY SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8623406 April 29, 2030 USE OF VASCEPA TO REDUCE TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8642077 April 29, 2030 USE OF VASCEPA TO REDUCE TRIGLYCERIDES IN A MIXED DYSLIPIDEMIA ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8691871 April 29, 2030 USE OF VASCEPA TO TREAT MIXED DYSLIPIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>=150 MG/DL) AND ON STATIN THERAPY
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8703185 April 29, 2030 USE OF VASCEPA TO TREAT HYPERTRIGLYCERIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8709475 April 29, 2030 USE OF VASCEPA TO TREAT MIXED DYSLIPIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>=150 MG/DL) AND ON STATIN THERAPY
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10010517 April 29, 2030 USE OF VASCEPA TO LOWER TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10265287 April 29, 2030 USE OF VASCEPA TO REDUCE TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON ROSUVASTATIN THERAPY
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10792267 April 29, 2030 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF MYOCARDIAL INFARCTION, STROKE, BOTH IN AN ADULT PATIENT WITH TYPE 2 DIABETES MELLITUS
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10842766 April 29, 2030 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF STROKE IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDES AND ATRIAL FIBRILLATION
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10881632 April 29, 2030 USE OF VASCEPA TO REDUCE TRIGLYCERIDE LEVELS IN AN ADULT PATIENT ON STATIN THERAPY AND HAVING ATRIAL FIBRILLATION AND TRIGLYCERIDE LEVELS OF GREATER THAN 500 MG/DL
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 11103477 April 29, 2030 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK MYOCARDIAL INFARCTION IN AN ADULT PATIENT HAVING ATRIAL FIBRILLATION OR ATRIAL FLUTTER AND ELEVATED TRIGLYCERIDE LEVELS
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 11154526 April 29, 2030 USE OF VASCEPA TO REDUCE TRIGLYCERIDE LEVELS IN AN ADULT PATIENT HAVING TRIGLYCERIDE LEVELS OF AT LEAST ABOUT 500 MG/DL, ON ANTICOAGULANT/ANTIPLATELET/THROMBOLYTIC THERAPY, AND HAVING ATRIAL FIBRILLATION AND/OR ATRIAL FLUTTER
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 11213504 April 29, 2030 USE OF VASCEPA TO REDUCE TRIGLYCERIDE LEVELS IN AN ADULT PATIENT ON STATIN THERAPY AND HAVING ATRIAL FIBRILLATION OR ATRIAL FLUTTER AND TRIGLYCERIDE LEVELS OF ABOUT 500 MG/DL TO ABOUT 2,000 MG/DL
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8445003 April 29, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8445013 April 29, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8454994 April 29, 2030 USE OF VASCEPA TO TREAT MIXED DYSLIPIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>=150 MG/DL) AND ON STATIN THERAPY
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8501225 April 29, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8551521 April 29, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8563608 April 29, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8617593 April 29, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8617593 April 29, 2030 USE OF VASCEPA TO TREAT HYPERTRIGLYCERIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8617594 April 29, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8623406 April 29, 2030 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8623406 April 29, 2030 USE OF VASCEPA TO REDUCE TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8642077 April 29, 2030 USE OF VASCEPA TO REDUCE TRIGLYCERIDES IN A MIXED DYSLIPIDEMIA ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8691871 April 29, 2030 USE OF VASCEPA TO TREAT MIXED DYSLIPIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>=150 MG/DL) AND ON STATIN THERAPY
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8703185 April 29, 2030 USE OF VASCEPA TO TREAT HYPERTRIGLYCERIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8709475 April 29, 2030 USE OF VASCEPA TO TREAT MIXED DYSLIPIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>=150 MG/DL) AND ON STATIN THERAPY
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10842768 June 15, 2030 USE OF VASCEPA TO LOWER TRIGLYCERIDES AND LDL-C IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8410086 June 15, 2030 USE OF VASCEPA TO LOWER TRIGLYCERIDES AND LDL-C IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8455472 June 15, 2030 USE OF VASCEPA TO LOWER TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8669245 June 15, 2030 USE OF VASCEPA TO LOWER TRIGLYCERIDES IN A MIXED DYSLIPIDEMIA ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 8710041 June 15, 2030 USE OF VASCEPA TO LOWER TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10842768 June 15, 2030 USE OF VASCEPA TO LOWER TRIGLYCERIDES AND LDL-C IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8410086 June 15, 2030 USE OF VASCEPA TO LOWER TRIGLYCERIDES AND LDL-C IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8669245 June 15, 2030 USE OF VASCEPA TO LOWER TRIGLYCERIDES IN A MIXED DYSLIPIDEMIA ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 8710041 June 15, 2030 USE OF VASCEPA TO LOWER TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO LESS THAN ABOUT 500 MG/DL) AND ON STATIN THERAPY
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10278935 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CORONARY REVASCULARIZATION AND/OR UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10278936 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CARDIOVASCULAR EVENT (CARDIOVASCULAR DEATH, CORONARY REVASCULARIZATION AND/OR UNSTABLE ANGINA) IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10278937 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CV EVENT (CV DEATH, CORONARY REVASCULARIZATION, UNSTABLE ANGINA, STROKE AND/OR MYOCARDIAL INFARCTION) IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND DIABETES MELLITUS
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10383840 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND AT LEAST ONE RISK FACTOR FOR CARDIOVASCULAR DISEASE
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10555924 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF UNSTABLE ANGINA IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10555925 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF STROKE IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10568861 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10576054 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A MAJOR CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH DIABETES MELLITUS AND TWO OR MORE ADDITIONAL RISK FACTORS FOR CARDIOVASCULAR DISEASE
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10668042 June 28, 2033 USE OF VASCEPA WITH HIGH INTENSITY STATIN THERAPY TO REDUCE THE RISK OF A CV EVENT IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND (1) ESTABLISHED CV DISEASE, OR (2) DIABETES MELLITUS AND TWO OR MORE ADDITIONAL RISK FACTORS FOR CV DISEASE
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10786478 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A SECOND OR FURTHER CARDIOVASCULAR (CV) EVENT IN AN ADULT PATIENT WITH ELEVATED TG LEVELS (>= 150 MG/DL) AND DIABETES MELLITUS AND 2 OR MORE ADDITIONAL RISK FACTORS FOR CV DISEASE
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10786478 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A THIRD AND FURTHER CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH ELEVATED TG LEVELS (>=150 MG/DL) AND ESTABLISHED CARDIOVASCULAR DISEASE
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10792270 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CORONARY REVASCULARIZATION IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 10894028 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF MYOCARDIAL INFARCTION IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND ESTABLISHED CV DISEASE OR DIABETES MELLITUS AND TWO OR MORE ADDITIONAL RISK FACTORS FOR CV DISEASE
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 11000499 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A SECOND AND FURTHER CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 11116742 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CARDIOVASCULAR EVENT IN A PATIENT WITH PRIOR PERCUTANEOUS CORONARY INTERVENTION
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 11298333 June 28, 2033 USE OF VASCEPA TO REDUCE THE INCIDENCE OF MI IN AN ADULT PATIENT ON STATIN THERAPY AND WITH ELEVATED TRIGLYCERIDE LEVELS (>150 MG/DL), WHEREIN THE PATIENT EXPERIENCES ATRIAL FIBRILLATION AND/OR FLUTTER INSTEAD OF AN INCIDENCE OF MI
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 9603826 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH, CORONARY REVASCULARIZATION, AND UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 9610272 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND/OR UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 9623001 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND/OR CORONARY REVASCULARIZATION IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 9693984 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND/OR UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 9693985 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH, CORONARY REVASCULARIZATION, AND UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 9693986 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND/OR CORONARY REVASCULARIZATION IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL 9918954 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CARDIOVASCULAR EVENT (CORONARY REVASCULARIZATION, UNSTABLE ANGINA, STROKE AND/OR MYOCARDIAL INFARCTION) IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10278935 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CORONARY REVASCULARIZATION AND/OR UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10278936 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CARDIOVASCULAR EVENT (CARDIOVASCULAR DEATH, CORONARY REVASCULARIZATION AND/OR UNSTABLE ANGINA) IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10278937 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CV EVENT (CV DEATH, CORONARY REVASCULARIZATION, UNSTABLE ANGINA, STROKE AND/OR MYOCARDIAL INFARCTION) IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND DIABETES MELLITUS
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10383840 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND AT LEAST ONE RISK FACTOR FOR CARDIOVASCULAR DISEASE
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10555924 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF UNSTABLE ANGINA IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10555925 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF STROKE IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10568861 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10576054 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A MAJOR CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH DIABETES MELLITUS AND TWO OR MORE ADDITIONAL RISK FACTORS FOR CARDIOVASCULAR DISEASE
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10668042 June 28, 2033 USE OF VASCEPA WITH HIGH INTENSITY STATIN THERAPY TO REDUCE THE RISK OF A CV EVENT IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND (1) ESTABLISHED CV DISEASE, OR (2) DIABETES MELLITUS AND TWO OR MORE ADDITIONAL RISK FACTORS FOR CV DISEASE
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10786478 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A SECOND OR FURTHER CARDIOVASCULAR (CV) EVENT IN AN ADULT PATIENT WITH ELEVATED TG LEVELS (>= 150 MG/DL) AND DIABETES MELLITUS AND 2 OR MORE ADDITIONAL RISK FACTORS FOR CV DISEASE
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10786478 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A THIRD AND FURTHER CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH ELEVATED TG LEVELS (>=150 MG/DL) AND ESTABLISHED CARDIOVASCULAR DISEASE
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10792270 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CORONARY REVASCULARIZATION IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 10894028 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF MYOCARDIAL INFARCTION IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS AND ESTABLISHED CV DISEASE OR DIABETES MELLITUS AND TWO OR MORE ADDITIONAL RISK FACTORS FOR CV DISEASE
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 11000499 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A SECOND AND FURTHER CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 11116742 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CARDIOVASCULAR EVENT IN A PATIENT WITH PRIOR PERCUTANEOUS CORONARY INTERVENTION
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 11298333 June 28, 2033 USE OF VASCEPA TO REDUCE THE INCIDENCE OF MI IN AN ADULT PATIENT ON STATIN THERAPY AND WITH ELEVATED TRIGLYCERIDE LEVELS (>150 MG/DL), WHEREIN THE PATIENT EXPERIENCES ATRIAL FIBRILLATION AND/OR FLUTTER INSTEAD OF AN INCIDENCE OF MI
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 9603826 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH, CORONARY REVASCULARIZATION, AND UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 9610272 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND/OR UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 9623001 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND/OR CORONARY REVASCULARIZATION IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 9693984 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND/OR UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 9693985 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH, CORONARY REVASCULARIZATION, AND UNSTABLE ANGINA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 9693986 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH AND/OR CORONARY REVASCULARIZATION IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS (TG >= 150 MG/DL TO ABOUT 500 MG/DL)
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL 9918954 June 28, 2033 USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF A CARDIOVASCULAR EVENT (CORONARY REVASCULARIZATION, UNSTABLE ANGINA, STROKE AND/OR MYOCARDIAL INFARCTION) IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE LEVELS

Orange Book exclusivity data (new drug applications)

Formulation strengthTrade nameApplicantApplication numberApproval dateTypeDose formRouteExclusivity dateDescription
1GM VASCEPA AMARIN PHARMS N202057 July 26, 2012 RX CAPSULE ORAL Dec. 13, 2022 ADJUNCT TO MAX TOLERATED STATIN TX TO REDUCE RISK OF MI, STROKE, CORONARY REVASCULARIZATION, & UNSTABLE ANGINA REQUIRING HOSPITALIZATION IN ADULTS W/ ELEVATED TG LEVELS & ESTABLISHED CV DISEASE OR DIABETES MELLITUS & 2+ RISK FACTORS FOR CV DISEASE
500MG VASCEPA AMARIN PHARMS N202057 Feb. 16, 2017 RX CAPSULE ORAL Dec. 13, 2022 ADJUNCT TO MAX TOLERATED STATIN TX TO REDUCE RISK OF MI, STROKE, CORONARY REVASCULARIZATION, & UNSTABLE ANGINA REQUIRING HOSPITALIZATION IN ADULTS W/ ELEVATED TG LEVELS & ESTABLISHED CV DISEASE OR DIABETES MELLITUS & 2+ RISK FACTORS FOR CV DISEASE

Bioactivity Summary:

TargetClassPharosUniProtActionTypeActivity value
(-log[M])
Mechanism
action
Bioact sourceMoA source
Diacylglycerol O-acyltransferase 1 Enzyme INHIBITOR DRUG LABEL DRUG LABEL

External reference:

IDSource
4032044 VUID
N0000186143 NUI
D01892 KEGG_DRUG
4032044 VANDF
CHEBI:84883 CHEBI
CHEMBL2095209 ChEMBL_ID
C035276 MESH_SUPPLEMENTAL_RECORD_UI
DB08887 DRUGBANK_ID
6GC8A4PAYH UNII
9831415 PUBCHEM_CID
1304974 RXNORM
192321 MMSL
28709 MMSL
340526 MMSL
014642 NDDF
C0058978 UMLSCUI

Pharmaceutical products:

ProductCategoryIngredientsNDCFormQuantityRouteMarketingLabel
Icosapent Ethyl HUMAN PRESCRIPTION DRUG LABEL 1 0054-0508 CAPSULE 1 g ORAL ANDA 26 sections
Icosapent HUMAN PRESCRIPTION DRUG LABEL 1 43598-267 CAPSULE 1000 mg ORAL ANDA 21 sections
Vascepa HUMAN PRESCRIPTION DRUG LABEL 1 52937-001 CAPSULE 1000 mg ORAL NDA 24 sections
Vascepa HUMAN PRESCRIPTION DRUG LABEL 1 52937-003 CAPSULE 500 mg ORAL NDA 24 sections
Vascepa HUMAN PRESCRIPTION DRUG LABEL 1 52937-101 CAPSULE 1000 mg ORAL NDA 24 sections
Icosapent Ethyl HUMAN PRESCRIPTION DRUG LABEL 1 60505-4033 CAPSULE 1 g ORAL ANDA 27 sections
Vascepa HUMAN PRESCRIPTION DRUG LABEL 1 63629-8247 CAPSULE 1000 mg ORAL NDA 23 sections