VASCEPA(R) Patent Families (1 gram) Applicable to Hikma's ANDA

All expiration dates include any applicable Sec. 156 and pediatric (PED) extensions.


VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL
Drug Classes: Cardiovascular Agents:Dyslipidemics, Other
NDA Applicant: AMARIN PHARMS      NDA No.: 202057   Prod. No.: 001 RX (1GM)
54 Patents--7 FamiliesExpirationPatented Use
Pat. No. 9198892 (Family Id: 37637079) Composition and/or method for preventing onset and/or recurrence of cardiovascular events
Claim Types: Method of improving a treatment
Pat. Sub. Date(s): 001: Jan 10, 2020
Sep 25, 2027U-2706: 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
Pat. No. 9700537 (Family Id: 38801375) Composition for preventing the occurrence of cardiovascular event in multiple risk patient
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 10, 2020
May 31, 2027U-2707: Use of VASCEPA as an adjunct to statin therapy to reduce the occurrence of a cardiovascular event in an adult patient with hypercholesterolemia
Pat. No. 8293727 (Family Id: 42102041) Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8293728 (Family Id: 42102041) Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8314086 (Family Id: 42102041) Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8318715 (Family Id: 42102041) Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Nov 29, 2012
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8357677 (Family Id: 42102041) Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8367652 (Family Id: 42102041) Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Feb 7, 2013
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8377920 (Family Id: 42102041) Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8399446 (Family Id: 42102041) Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Apr 17, 2013
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8415335 (Family Id: 42102041) Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Apr 17, 2013
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8426399 (Family Id: 42102041) Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8431560 (Family Id: 42102041) Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8440650 (Family Id: 42102041) Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8518929 (Family Id: 42102041) Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: None
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8524698 (Family Id: 42102041) Methods of treating hypertriglyceridemia
Claim Types: Method of administration
Pat. Sub. Date(s): 001: Sep 11, 2013
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8546372 (Family Id: 42102041) Methods of treating hypertriglyceridemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 1, 2013
Feb 9, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8298554 DP* (Family Id: 43030519) Stable pharmaceutical composition and methods of using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Apr 29, 2030 
Pat. No. 8445003 (Family Id: 43030519) Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8445013 (Family Id: 43030519) Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8454994 (Family Id: 43030519) Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Apr 29, 2030U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy
Pat. No. 8501225 (Family Id: 43030519) Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8551521 (Family Id: 43030519) Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 9, 2013
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8617593 (Family Id: 43030519) Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 14, 2014
Apr 29, 2030U-1478: Method of reducing TG levels in patient on statin therapy suffering from severe hypertriglyceridemia
U-2691: Use of VASCEPA to treat hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8617594 (Family Id: 43030519) Stable pharmaceutical composition and methods of using same
Claim Types: Method of administration
Pat. Sub. Date(s): 001: None
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8623406 (Family Id: 43030519) Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 14, 2014
Apr 29, 2030U-1478: Method of reducing TG levels in patient on statin therapy suffering from severe hypertriglyceridemia
U-2692: Use of VASCEPA to reduce triglycerides in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8642077 (Family Id: 43030519) Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Apr 29, 2030U-2693: Use of VASCEPA to reduce triglycerides in a mixed dyslipidemia adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8703185 (Family Id: 43030519) Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Apr 29, 2030U-2691: Use of VASCEPA to treat hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8709475 (Family Id: 43030519) Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Apr 29, 2030U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy
Pat. No. 10010517 (Family Id: 43030519) Stable pharmaceutical composition and methods of using same
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Apr 29, 2030U-2690: 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
Pat. No. 8563608 (Family Id: 43032772) Methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Oct 22, 2013
Apr 29, 2030U-1287: Method of reducing tg levels in patient suffering from severe hypertriglyceridemia
Pat. No. 8618166 (Family Id: 43032772) Methods of treating mixed dyslipidemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Apr 29, 2030U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy
Pat. No. 8680144 (Family Id: 43032772) Methods of treating mixed dyslipidemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Feb 9, 2030U-2695: Use of VASCEPA to treat mixed hypertriglyceridemia in an adult patient with elevated triglyceride (TG) levels (>= 150 mg/dl) and on statin therapy
Pat. No. 8691871 (Family Id: 43032772) Methods of treating mixed dyslipidemia
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Apr 29, 2030U-2689: Use of VASCEPA to treat mixed dyslipidemia in an adult patient with elevated triglyceride (TG) levels (>=150 mg/dl) and on statin therapy
Pat. No. 10265287 (Family Id: 43032772) Methods of reducing triglycerides and LDL-C
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Apr 29, 2030U-2700: 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
Pat. No. 8410086 (Family Id: 43356721) Compositions and methods for lowering triglycerides
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 15, 2030U-2688: 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
Pat. No. 8455472 (Family Id: 43356721) Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 15, 2030U-2690: 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
Pat. No. 8669245 (Family Id: 43356721) Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 15, 2030U-2694: 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
Pat. No. 8710041 (Family Id: 43356721) Compositions and methods for lowering triglycerides in a subject on concomitant statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 15, 2030U-2690: 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
Pat. No. 9603826 (Family Id: 49784037) Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2696: 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)
Pat. No. 9610272 (Family Id: 49784037) Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2697: 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)
Pat. No. 9623001 (Family Id: 49784037) Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2698: 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)
Pat. No. 9693984 (Family Id: 49784037) Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2697: 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)
Pat. No. 9693985 (Family Id: 49784037) Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2696: 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)
Pat. No. 9693986 (Family Id: 49784037) Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2698: 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)
Pat. No. 9918954 (Family Id: 49784037) Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2699: 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
Pat. No. 10278935 (Family Id: 49784037) Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2701: 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)
Pat. No. 10278936 (Family Id: 49784037) Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2702: 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
Pat. No. 10278937 (Family Id: 49784037) Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2703: 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
Pat. No. 10383840 (Family Id: 49784037) Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jan 6, 2020
Jun 28, 2033U-2704: 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
Pat. No. 10555924 (Family Id: 49784037) Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 26, 2020
Jun 28, 2033U-2743: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of unstable angina in an adult patient with established cardiovascular disease
Pat. No. 10555925 (Family Id: 49784037) Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Feb 26, 2020
Jun 28, 2033U-2744: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of stroke in an adult patient with established cardiovascular disease
Pat. No. 10568861 (Family Id: 49784037) Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 20, 2020
Jun 28, 2033U-2756: Use of VASCEPA as an adjunct to statin therapy to reduce the risk of cardiovascular death in an adult patient with established cardiovascular disease
Pat. No. 10576054 (Family Id: 49784037) Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Claim Types: Method of use
Pat. Sub. Date(s): 001: Mar 27, 2020
Jun 28, 2033U-2762: 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
ExclusivityExpirationExclusivity Description
Exclusivity Code: I - New IndicationDec 13, 2022I-819: Adjunct to max tolerated statin tx to reduce risk of MI, stroke, coronary revascularization, & unstable angina requiring hospitalization in adults w/ elevated TG levels & established CV disease or diabetes mellitus & 2+ risk factors for CV disease


DS*=Drug Substance and DP*=Drug Product: patent submitted for the product after Aug. 18, 2003.
** Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons
Last edited: 13 June 2022
2001-2022 Bruce A. Pokras, All rights reserved worldwide