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

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	136.81	22.37	28	3807	1268	63483919
Rheumatic disorder	88.11	22.37	23	3812	3049	63482138
Prescribed underdose	83.07	22.37	39	3796	29650	63455537
Blood immunoglobulin M increased	76.71	22.37	17	3818	1126	63484061
Blood immunoglobulin A decreased	74.31	22.37	17	3818	1300	63483887
Colitis microscopic	66.65	22.37	24	3811	9315	63475872
Blood immunoglobulin G increased	63.99	22.37	17	3818	2410	63482777
Cataract operation	58.19	22.37	19	3816	5503	63479684
Multiple allergies	57.54	22.37	24	3811	13778	63471409
Hernia	56.27	22.37	23	3812	12551	63472636
Product physical issue	55.99	22.37	18	3817	4962	63480225
Blood triglycerides increased	53.02	22.37	22	3813	12466	63472721
Skin reaction	52.58	22.37	23	3812	14826	63470361
Glaucoma	50.30	22.37	24	3811	18881	63466306
Blood glucose increased	47.93	22.37	40	3795	83716	63401471
Hepatic enzyme abnormal	47.77	22.37	17	3818	6375	63478812
Multiple fractures	46.34	22.37	18	3817	8600	63476587
Eye disorder	46.15	22.37	24	3811	22661	63462526
Drug-induced liver injury	45.43	22.37	29	3806	40193	63444994
Myelosuppression	45.16	22.37	24	3811	23679	63461508
Product taste abnormal	38.40	22.37	11	3824	2056	63483131
Sciatica	36.91	22.37	24	3811	34300	63450887
Bronchitis	36.09	22.37	41	3794	124894	63360293
White blood cell count decreased	34.13	22.37	42	3793	139062	63346125
Cataract	32.10	22.37	27	3808	57026	63428161
Diverticulitis	31.53	22.37	23	3812	39534	63445653
Platelet count decreased	30.01	22.37	36	3799	116086	63369101
Red blood cell sedimentation rate increased	29.35	22.37	23	3812	43959	63441228
Immunodeficiency	28.99	22.37	17	3818	20237	63464950
Eructation	26.58	22.37	12	3823	8321	63476866
Blood pressure increased	26.21	22.37	40	3795	162022	63323165
Intentional underdose	26.15	22.37	8	3827	1874	63483313
Blood alkaline phosphatase increased	25.55	22.37	21	3814	42946	63442241
Anaphylactic reaction	24.91	22.37	25	3810	66075	63419112
Psoriatic arthropathy	24.67	22.37	29	3806	91491	63393696
Drug resistance	24.56	22.37	16	3819	22917	63462270
Herpes zoster	23.68	22.37	27	3808	82435	63402752
Gamma-glutamyltransferase increased	23.15	22.37	18	3817	34013	63451174

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	332.76	23.70	57	2728	719	34953427
Product physical issue	135.49	23.70	33	2752	2508	34951638
Product taste abnormal	120.53	23.70	26	2759	1148	34952998
Blood triglycerides increased	100.57	23.70	39	2746	14120	34940026
Prescribed underdose	86.87	23.70	31	2754	8902	34945244
Eructation	48.18	23.70	17	2768	4714	34949432
Product adhesion issue	42.69	23.70	12	2773	1588	34952558
Blood triglycerides abnormal	39.59	23.70	8	2777	255	34953891
Hyperkinetic heart syndrome	38.74	23.70	7	2778	121	34954025
Cerebral infarction	28.75	23.70	21	2764	27434	34926712
Hepatic function abnormal	25.58	23.70	24	2761	44339	34909807
Product residue present	24.69	23.70	9	2776	2737	34951409
Echocardiogram abnormal	24.00	23.70	7	2778	1056	34953090

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	255.43	19.56	49	5812	1295	79737232
Product physical issue	117.03	19.56	32	5829	4153	79734374
Prescribed underdose	103.00	19.56	48	5813	29466	79709061
Product taste abnormal	95.46	19.56	24	5837	2247	79736280
Rheumatic disorder	82.99	19.56	23	5838	3135	79735392
Blood immunoglobulin M increased	70.37	19.56	17	5844	1349	79737178
Blood triglycerides increased	69.63	19.56	33	5828	21007	79717520
Blood immunoglobulin A decreased	69.32	19.56	17	5844	1436	79737091
Colitis microscopic	65.64	19.56	26	5835	10742	79727785
Cataract operation	59.62	19.56	20	5841	5165	79733362
Blood immunoglobulin G increased	57.17	19.56	17	5844	2972	79735555
Multiple allergies	55.98	19.56	23	5838	10437	79728090
Product adhesion issue	54.43	19.56	16	5845	2688	79735839
Hernia	51.12	19.56	25	5836	17034	79721493
Glaucoma	47.64	19.56	25	5836	19736	79718791
Skin reaction	46.51	19.56	23	5838	16045	79722482
Cerebral infarction	45.85	19.56	33	5828	45643	79692884
Hepatic enzyme abnormal	44.62	19.56	18	5843	7792	79730735
Multiple fractures	44.14	19.56	18	5843	8008	79730519
Eye disorder	41.01	19.56	24	5837	23388	79715139
Hyperkinetic heart syndrome	38.77	19.56	7	5854	131	79738396
Eructation	35.74	19.56	17	5844	10892	79727635
Blood triglycerides abnormal	35.22	19.56	8	5853	485	79738042
White blood cell count decreased	32.14	19.56	53	5808	188235	79550292
Drug-induced liver injury	31.36	19.56	31	5830	66086	79672441
Myelosuppression	31.33	19.56	25	5836	40271	79698256
Sciatica	31.06	19.56	23	5838	33199	79705328
Platelet count decreased	30.84	19.56	53	5808	194611	79543916
Blood glucose increased	30.72	19.56	40	5821	114935	79623592
Hepatic function abnormal	30.53	19.56	32	5829	73075	79665452
Diverticulitis	30.50	19.56	26	5835	45910	79692617
Renal impairment	27.71	19.56	45	5816	157738	79580789
Bronchitis	26.76	19.56	40	5821	130604	79607923
Cataract	25.60	19.56	27	5834	62093	79676434
Immunodeficiency	24.80	19.56	17	5844	21751	79716776
Red blood cell sedimentation rate increased	24.54	19.56	23	5838	45919	79692608
Psoriatic arthropathy	23.79	19.56	29	5832	77970	79660557
Blood pressure increased	22.92	19.56	49	5812	211311	79527216
Herpes zoster	22.73	19.56	31	5830	93052	79645475
Interstitial lung disease	22.38	19.56	34	5827	112566	79625961
Cystitis	21.87	19.56	23	5838	52709	79685818

FDA Adverse Event Reporting System (Pediatric)

None

Pharmacologic Action:

Source	Code	Description
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 | 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	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	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)

Formulation strength	Trade name	Applicant	Application number	Approval date	Type	Dose form	Route	Exclusivity date	Description
500MG	ICOSAPENT ETHYL	TEVA PHARMS USA	A209525	Sept. 11, 2020	RX	CAPSULE	ORAL	March 8, 2023	PATENT CHALLENGE

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
C035276	MESH_SUPPLEMENTAL_RECORD_UI
DB08887	DRUGBANK_ID
6GC8A4PAYH	UNII
1304974	RXNORM
192321	MMSL
28709	MMSL
340526	MMSL
014642	NDDF
C0058978	UMLSCUI
9831415	PUBCHEM_CID

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	26 sections
Icosapent Ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0508	CAPSULE	1 g	ORAL	ANDA	26 sections
Icosapent Ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	0054-0621	CAPSULE	0.50 g	ORAL	ANDA	26 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	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
Vascepa	HUMAN PRESCRIPTION DRUG LABEL	1	52937-001	CAPSULE	1000 mg	ORAL	NDA	24 sections
Vascepa	HUMAN PRESCRIPTION DRUG LABEL	1	52937-001	CAPSULE	1000 mg	ORAL	NDA	24 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	52937-003	CAPSULE	500 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
Vascepa	HUMAN PRESCRIPTION DRUG LABEL	1	52937-101	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	60505-4033	CAPSULE	1 g	ORAL	ANDA	27 sections
Vascepa	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8247	CAPSULE	1000 mg	ORAL	NDA	23 sections
Vascepa	HUMAN PRESCRIPTION DRUG LABEL	1	63629-8247	CAPSULE	1000 mg	ORAL	NDA	23 sections
Icosapent Ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	63629-9311	CAPSULE	1 g	ORAL	ANDA	26 sections
Icosapent	HUMAN PRESCRIPTION DRUG LABEL	1	63629-9312	CAPSULE	1000 mg	ORAL	ANDA	20 sections
icosapent ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	70710-1592	CAPSULE	1 g	ORAL	ANDA	22 sections
icosapent ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	70710-1738	CAPSULE	0.50 g	ORAL	ANDA	22 sections
Icosapent Ethyl	HUMAN PRESCRIPTION DRUG LABEL	1	72603-129	CAPSULE	1 g	ORAL	ANDA	25 sections