Tox | Related Drugs | BioActivity |

Stem definition	Drug id	CAS RN
	1413	86227-47-6

Description:

Molecule	Description
Molfile Inchi Smiles Synonyms: ethyl-eicosapent ethyl eicosapent ethyl-eicosapentaenoic acid icosapent ethyl vascepa ethyl eicosapentaenoate ethyl icosapentate timnodonic acid ethyl ester epadel	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

Molecule

Description

Molfile Inchi Smiles

Synonyms:

ethyl-eicosapent
ethyl eicosapent
ethyl-eicosapentaenoic acid
icosapent ethyl
vascepa
ethyl eicosapentaenoate
ethyl icosapentate
timnodonic acid ethyl ester
epadel

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

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Property	Description	Value
kinase-safety-class	ACVR2A,ACVR2B,ACVRL1,AURKA,AXL,BRAF,BTK,CAMK2B,CAMK2D,CDK4,CDK5,CDK9,DDR1,DYRK1B,EGFR,EIF2AK3,EPHB4,ERBB2,FLT3,GRK2,GSK3B,IKBKB,ITK,JAK1,JAK2,JAK3,MAP2K6,MAP3K21,MAP3K7,MAPK12,MAPK7,MAPK9,MAPKAPK2,MTOR,NTRK2,PDK1,PDK2,PDK4,PDPK1,PIK3CB,PIK3CG,PIM2,PLK1,PRKCD,PRKDC,SIK2,SIK3,STK33,SYK,TEK,TGFBR1,TTK,ULK1,ZAP70	54
kinase-selectivity-class	AXL,GRK2,MAP2K6,STK33,TEK	5
pfas-class	PFAS structural alert (1 = True, 0 = False)	0

Approvals:

Date	Agency	Company
March 26, 2021	EMA	Amarin Pharmaceuticals Ireland Limited
July 26, 2012	FDA	AMARIN PHARMS
June 20, 2022	PMDA	MOCHIDA PHARMACEUTICAL CO., LTD

FDA Adverse Event Reporting System (Female)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Product odour abnormal	205.39	17.59	46	11255	1525	90615621
Overlap syndrome	187.10	17.59	61	11240	8487	90608659
Product physical issue	142.77	17.59	45	11256	5615	90611531
Milk-alkali syndrome	81.76	17.59	21	11280	1252	90615894
Rheumatic disorder	81.41	17.59	26	11275	3382	90613764
Hepatic necrosis	79.47	17.59	30	11271	6408	90610738
Drug-induced liver injury	78.65	17.59	75	11226	90243	90526903
Prescribed underdose	76.40	17.59	68	11233	74951	90542195
Blood immunoglobulin M increased	75.42	17.59	20	11281	1352	90615794
Poor quality product administered	73.34	17.59	25	11276	3983	90613163
Blood immunoglobulin A decreased	70.53	17.59	20	11281	1736	90615410
Blood immunoglobulin G increased	60.16	17.59	20	11281	2952	90614194
Hepatic encephalopathy	57.57	17.59	30	11271	13742	90603404
Colitis microscopic	54.49	17.59	27	11274	11132	90606014
Condition aggravated	52.35	17.59	178	11123	595367	90021779
Blood triglycerides increased	49.15	17.59	27	11274	13734	90603412
Hernia	48.31	17.59	27	11274	14204	90602942
Sciatica	47.75	17.59	61	11240	101321	90515825
Multiple allergies	46.74	17.59	27	11274	15119	90602027
Mobility decreased	46.58	17.59	99	11202	250635	90366511
Cataract operation	45.97	17.59	20	11281	6143	90611003
Type 2 diabetes mellitus	42.15	17.59	84	11217	203160	90413986
Hepatic enzyme abnormal	41.85	17.59	20	11281	7622	90609524
Psoriatic arthropathy	41.07	17.59	89	11212	228246	90388900
Product taste abnormal	39.81	17.59	14	11287	2446	90614700
Skin reaction	39.24	17.59	26	11275	18527	90598619
Glaucoma	38.93	17.59	27	11274	20728	90596418
Musculoskeletal pain	38.21	17.59	73	11228	171178	90445968
Multiple fractures	37.60	17.59	20	11281	9542	90607604
Maternal exposure during pregnancy	36.40	17.59	113	11188	359950	90257196
Hypoaesthesia	35.92	17.59	103	11198	314107	90303039
Fibromyalgia	34.38	17.59	78	11223	206191	90410955
Eye disorder	34.35	17.59	28	11273	27362	90589784
Hepatotoxicity	34.18	17.59	35	11266	45807	90571339
Stomatitis	33.30	17.59	92	11209	274606	90342540
Hepatic cirrhosis	31.26	17.59	39	11262	63214	90553932
C-reactive protein increased	30.67	17.59	69	11232	181320	90435826
Calculus urinary	28.77	17.59	10	11291	1688	90615458
Urticaria	28.72	17.59	95	11206	312639	90304507
Lip dry	27.56	17.59	47	11254	100908	90516238
Blood glucose increased	26.87	17.59	45	11256	95201	90521945
Nail disorder	25.40	17.59	34	11267	59033	90558113
C-reactive protein	25.31	17.59	25	11276	31342	90585804
Osteoarthritis	25.15	17.59	67	11234	195663	90421483
Road traffic accident	24.13	17.59	46	11255	107580	90509566
Adverse event	23.68	17.59	48	11253	117370	90499776
Breast cancer stage III	22.63	17.59	39	11262	84408	90532738
Diverticulitis	22.55	17.59	28	11273	45159	90571987
Drug resistance	22.24	17.59	23	11278	30426	90586720
Epilepsy	22.07	17.59	38	11263	82168	90534978
Wound infection	22.06	17.59	44	11257	106358	90510788
Nasopharyngitis	21.48	17.59	104	11197	407000	90210146
Helicobacter infection	20.89	17.59	69	11232	226781	90390365
Gastric ulcer haemorrhage	20.58	17.59	11	11290	5300	90611846
Sinusitis	20.57	17.59	91	11210	342997	90274149
Immunodeficiency	20.32	17.59	26	11275	43208	90573938
Pain	20.03	17.59	61	11240	996280	89620866
Intentional underdose	19.81	17.59	8	11293	2041	90615105
Ulcer haemorrhage	19.44	17.59	20	11281	26301	90590845
Live birth	19.22	17.59	35	11266	79072	90538074
Obesity	18.79	17.59	41	11260	105466	90511680
Product colour issue	18.74	17.59	6	11295	786	90616360
Muscle injury	18.33	17.59	56	11245	176598	90440548
Rheumatoid arthritis	17.96	17.59	91	11210	362523	90254623
Eructation	17.74	17.59	13	11288	10869	90606277
Cataract	17.64	17.59	32	11269	72060	90545086

FDA Adverse Event Reporting System (Male)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Product odour abnormal	509.54	20.93	87	4193	835	42616220
Product physical issue	297.00	20.93	68	4212	3131	42613924
Poor quality product administered	161.31	20.93	39	4241	2269	42614786
Product taste abnormal	140.30	20.93	31	4249	1208	42615847
Blood triglycerides increased	110.43	20.93	46	4234	15850	42601205
Prescribed underdose	75.60	20.93	31	4249	10251	42606804
Product colour issue	66.98	20.93	15	4265	621	42616434
Eructation	52.43	20.93	20	4260	5466	42611589
Urine albumin/creatinine ratio decreased	45.25	20.93	7	4273	33	42617022
Product adhesion issue	38.95	20.93	12	4268	1727	42615328
Blood triglycerides abnormal	37.68	20.93	8	4272	257	42616798
Hyperkinetic heart syndrome	37.12	20.93	7	4273	121	42616934
Cerebral infarction	36.56	20.93	28	4252	31141	42585914
Product residue present	29.47	20.93	11	4269	2830	42614225
Diabetes mellitus	27.50	20.93	32	4248	60055	42557000
Hepatic function abnormal	24.50	20.93	28	4252	51539	42565516
Product size issue	24.32	20.93	7	4273	798	42616257
Thrombotic cerebral infarction	23.14	20.93	6	4274	463	42616592
Echocardiogram abnormal	21.17	20.93	7	4273	1263	42615792

FDA Adverse Event Reporting System (Geriatric)

MedDRA adverse event term	Likelihood ratio	Likelihood ratio threshold	Patients taking drug having adverse event	Patients taking drug not having adverse event	Patients not taking drug having adverse event	Patients not taking drug not having adverse event
Product odour abnormal	431.85	16.00	85	13568	1498	110574148
Product physical issue	280.49	16.00	74	13579	4962	110570684
Overlap syndrome	188.20	16.00	62	13591	8997	110566649
Poor quality product administered	156.39	16.00	46	13607	4595	110571051
Product taste abnormal	97.99	16.00	28	13625	2524	110573122
Prescribed underdose	83.18	16.00	67	13586	65107	110510539
Rheumatic disorder	80.33	16.00	26	13627	3565	110572081
Blood triglycerides increased	77.86	16.00	44	13609	23882	110551764
Milk-alkali syndrome	72.52	16.00	21	13632	1984	110573662
Blood immunoglobulin M increased	72.11	16.00	20	13633	1617	110574029
Hepatic necrosis	67.20	16.00	30	13623	9892	110565754
Drug-induced liver injury	66.49	16.00	78	13575	119989	110455657
Blood immunoglobulin A decreased	65.84	16.00	20	13633	2228	110573418
Colitis microscopic	55.75	16.00	29	13624	13365	110562281
Maternal exposure during pregnancy	55.63	16.00	107	13546	254776	110320870
Blood immunoglobulin G increased	55.49	16.00	20	13633	3788	110571858
Multiple allergies	52.33	16.00	27	13626	12236	110563410
Cataract operation	50.39	16.00	21	13632	5862	110569784
Sciatica	47.81	16.00	58	13595	92341	110483305
Toxicity to various agents	47.49	16.00	3	13650	480552	110095094
Type 2 diabetes mellitus	47.03	16.00	81	13572	177151	110398495
Hernia	45.61	16.00	29	13624	19471	110556175
Cerebral infarction	45.36	16.00	43	13610	51795	110523851
Product adhesion issue	44.60	16.00	16	13637	2990	110572656
Hepatic encephalopathy	42.44	16.00	32	13621	28224	110547422
Glaucoma	41.81	16.00	29	13624	22488	110553158
Hepatic enzyme abnormal	40.23	16.00	21	13632	9742	110565904
Psoriatic arthropathy	39.76	16.00	80	13573	196681	110378965
Mobility decreased	39.29	16.00	89	13564	237333	110338313
Multiple fractures	39.06	16.00	20	13633	8920	110566726
Product colour issue	38.11	16.00	11	13642	1027	110574619
Hepatic cirrhosis	37.53	16.00	44	13609	67582	110508064
Skin reaction	36.39	16.00	26	13627	21118	110554528
Osteoarthritis	35.41	16.00	73	13580	182550	110393096
Musculoskeletal pain	35.30	16.00	73	13580	182950	110392696
Fibromyalgia	35.13	16.00	70	13583	170839	110404807
Hyperkinetic heart syndrome	34.66	16.00	7	13646	141	110575505
Eructation	33.11	16.00	21	13632	14036	110561610
Hypoaesthesia	32.68	16.00	99	13554	314124	110261522
Condition aggravated	31.63	16.00	176	13477	734660	109840986
Eye disorder	31.23	16.00	27	13626	28879	110546767
Stomatitis	29.85	16.00	87	13566	270155	110305491
Blood triglycerides abnormal	29.68	16.00	8	13645	581	110575065
Lip dry	29.54	16.00	48	13605	100035	110475611
Nail disorder	29.36	16.00	36	13617	57899	110517747
Hepatotoxicity	28.33	16.00	37	13616	63363	110512283
Wound infection	28.11	16.00	46	13607	96419	110479227
C-reactive protein	26.23	16.00	25	13628	30306	110545340
Breast cancer stage III	26.19	16.00	40	13613	79077	110496569
Calculus urinary	26.15	16.00	11	13642	3141	110572505
Nasopharyngitis	26.07	16.00	107	13546	394254	110181392
Helicobacter infection	25.55	16.00	64	13589	181813	110393833
Diverticulitis	25.11	16.00	32	13621	53490	110522156
Road traffic accident	24.52	16.00	46	13607	107352	110468294
Sinusitis	24.12	16.00	86	13567	296602	110279044
Rheumatoid arthritis	23.64	16.00	86	13567	299527	110276119
Adverse event	22.87	16.00	45	13608	108764	110466882
Immunodeficiency	22.77	16.00	26	13627	38812	110536834
C-reactive protein increased	22.02	16.00	68	13585	217851	110357795
Product leakage	21.72	16.00	8	13645	1610	110574036
Thrombocytopenia	21.65	16.00	8	13645	348877	110226769
Obesity	21.59	16.00	45	13608	113306	110462340
Urticaria	21.44	16.00	87	13566	318770	110256876
Muscle injury	21.32	16.00	51	13602	140756	110434890
Sleep disorder due to general medical condition, insomnia type	20.19	16.00	42	13611	105601	110470045
Completed suicide	20.05	16.00	3	13650	242378	110333268
Epilepsy	19.34	16.00	40	13613	100169	110475477
Facet joint syndrome	19.10	16.00	39	13614	96789	110478857
Blood glucose increased	19.00	16.00	47	13606	132449	110443197
Hepatic function abnormal	18.85	16.00	37	13616	89258	110486388
Gastric ulcer haemorrhage	18.74	16.00	13	13640	10081	110565565
Intentional underdose	18.19	16.00	8	13645	2544	110573102
Hypotension	17.96	16.00	23	13630	523826	110051820
Live birth	17.42	16.00	31	13622	69453	110506193
Renal impairment	17.39	16.00	57	13596	188388	110387258
Cystitis	17.26	16.00	30	13623	66006	110509640
Red blood cell sedimentation rate increased	17.20	16.00	33	13620	78269	110497377
Bronchitis	16.79	16.00	50	13603	156982	110418664

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
MeSH PA	D006401	Hematologic Agents
MeSH PA	D010975	Platelet Aggregation Inhibitors
MeSH PA	D057847	Lipid Regulating Agents
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 | Suggest Off label Use Form| |View source of the data|

Disease	Relation	SNOMED_ID	DOID
Hyperlipidemia	indication	55822004	DOID:1168
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 strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Patent number	Patent expiration date	Patent 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	12171738	Feb. 9, 2030	USE OF VASCEPA TO LOWER TRIGLYCERIDES AND LDL-C IN AN ADULT PATIENT ON STATIN THERAPY WITH CARDIOVASCULAR-RELATED DISEASE AND ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO ABOUT 500 MG/DL)
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	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	12171738	Feb. 9, 2030	USE OF VASCEPA TO LOWER TRIGLYCERIDES AND LDL-C IN AN ADULT PATIENT ON STATIN THERAPY WITH CARDIOVASCULAR-RELATED DISEASE AND ELEVATED TRIGLYCERIDE (TG) LEVELS (ABOUT 200 MG/DL TO ABOUT 500 MG/DL)
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	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	11717504	April 29, 2030	USE OF VASCEPA TO REDUCE THE INCIDENCE OF STROKE 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 STROKE
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	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	11717504	April 29, 2030	USE OF VASCEPA TO REDUCE THE INCIDENCE OF STROKE 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 STROKE
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	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	11369582	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	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	11369582	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	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)

None

Bioactivity Summary:

Target	Class	Pharos	UniProt	Action	Type	Activity value (-log[M])	Mechanism action	Bioact source	MoA source
Diacylglycerol O-acyltransferase 1	Enzyme	O75907	DGAT1_HUMAN	INHIBITOR				DRUG LABEL	DRUG LABEL

External reference:

ID	Source
4032044	VUID
N0000186143	NUI
D01892	KEGG_DRUG
4032044	VANDF
CHEBI:84883	CHEBI
CHEMBL2095209	ChEMBL_ID
DB08887	DRUGBANK_ID
6GC8A4PAYH	UNII
1304974	RXNORM
192321	MMSL
28709	MMSL
340526	MMSL
014642	NDDF
21371411000001106	SNOMEDCT_US
C0058978	UMLSCUI
9831415	PUBCHEM_CID
C035276	MESH_SUPPLEMENTAL_RECORD_UI
6GC8A4PAYH	INXIGHT DRUGS

Pharmaceutical products:

Product	Category	Ingredients	NDC	Form	Quantity	Route	Marketing	Label
Icosapent Ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0508	CAPSULE	1 g	ORAL	ANDA	25 sections
Icosapent Ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0621	CAPSULE	0.50 g	ORAL	ANDA	25 sections
Icosapent Ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	0480-0126	CAPSULE, LIQUID FILLED	500 mg	ORAL	ANDA	25 sections
Icosapent Ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	0480-0126	CAPSULE, LIQUID FILLED	500 mg	ORAL	ANDA	25 sections
Icosapent Ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	0480-0127	CAPSULE, LIQUID FILLED	1 g	ORAL	ANDA	25 sections
Icosapent Ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	0480-0127	CAPSULE, LIQUID FILLED	1 g	ORAL	ANDA	25 sections
Icosapent Ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	13668-761	CAPSULE, LIQUID FILLED	1 g	ORAL	ANDA	25 sections
ICOSAPENT ETHYL	HUMAN PRESCRIPTION DRUG LABEL	1	16714-636	CAPSULE	1 g	ORAL	ANDA	21 sections
ICOSAPENT ETHYL	HUMAN PRESCRIPTION DRUG LABEL	1	31722-298	CAPSULE	0.50 g	ORAL	ANDA	22 sections
ICOSAPENT ETHYL	HUMAN PRESCRIPTION DRUG LABEL	1	31722-299	CAPSULE	1 g	ORAL	ANDA	22 sections
icosapent ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	35916-1592	CAPSULE	1 g	ORAL	ANDA	2 sections
icosapent ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	35916-1738	CAPSULE	0.50 g	ORAL	ANDA	2 sections
Icosapent Ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	42291-046	CAPSULE, LIQUID FILLED	1 g	ORAL	ANDA	25 sections
ICOSAPENT ETHYL	HUMAN PRESCRIPTION DRUG LABEL	1	42806-559	CAPSULE, LIQUID FILLED	0.50 g	ORAL	ANDA	25 sections
ICOSAPENT ETHYL	HUMAN PRESCRIPTION DRUG LABEL	1	42806-560	CAPSULE, LIQUID FILLED	1 g	ORAL	ANDA	25 sections
ICOSAPENT ETHYL	HUMAN PRESCRIPTION DRUG LABEL	1	42806-576	CAPSULE, LIQUID FILLED	1 g	ORAL	ANDA	25 sections
Icosapent	HUMAN PRESCRIPTION DRUG LABEL	1	43598-267	CAPSULE	1000 mg	ORAL	ANDA	21 sections
Icosapent Ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	43598-746	CAPSULE	500 mg	ORAL	ANDA	22 sections
ICOSAPENT ETHYL	HUMAN PRESCRIPTION DRUG LABEL	1	43602-291	CAPSULE	1 g	ORAL	ANDA	22 sections
ICOSAPENT ETHYL	HUMAN PRESCRIPTION DRUG LABEL	1	43602-547	CAPSULE	0.50 g	ORAL	ANDA	22 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	52937-005	CAPSULE	1000 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	59651-812	CAPSULE	1 g	ORAL	ANDA	25 sections
Icosapent Ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	60429-005	CAPSULE	1 g	ORAL	ANDA	27 sections
Icosapent Ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	60505-4033	CAPSULE	1 g	ORAL	ANDA	25 sections
Icosapent Ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	60687-764	CAPSULE	1 g	ORAL	ANDA	26 sections
Vascepa	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8247	CAPSULE	1000 mg	ORAL	NDA	24 sections
Icosapent Ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	63629-9311	CAPSULE	1 g	ORAL	ANDA	26 sections

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

Description:

Drug dosage:

ADMET properties:

Predicted pharmacokinetic/toxicological properties (PK-AZ):

Approvals:

FDA Adverse Event Reporting System (Female)

FDA Adverse Event Reporting System (Male)

FDA Adverse Event Reporting System (Geriatric)

FDA Adverse Event Reporting System (Pediatric)

Pharmacologic Action:

Drug Use | Suggest Off label Use Form| |View source of the data|

🐶 Veterinary Drug Use

🐶 Veterinary products

Acid dissociation constants calculated using MoKa v3.0.0

Orange Book patent data (new drug applications)

Orange Book exclusivity data (new drug applications)

Bioactivity Summary:

External reference:

Pharmaceutical products: