VASCEPAź

Patents whose numbers are in italics have been extended under 35 USC 156. All expiration dates include applicable Sec. 156 and pediatric (PED) extensions.
Products tagged as [GENERIC] have had a generic equivalent approved for at least one strength of the product.


VASCEPA (CAPSULE) (ORAL) ICOSAPENT ETHYL [GENERIC AB]
NDA Applicant: AMARIN PHARMS      NDA No.: 202057  Prod. No.: 001 RX (1GM)
PatentsExpirationPatented Use
Pat. No. 8188146 DS* DP* Highly purified ethyl EPA and other EPA derivatives
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Jan 27, 2020 
Pat. No. 8293727 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 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. 8298554 DP* Stable pharmaceutical composition and methods of using same
Claim Types: Formulation
Pat. Sub. Date(s): 001: None
Apr 29, 2030 
Pat. No. 8314086 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 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 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 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 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 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. 8410086 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. 8415335 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 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 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 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. 8445003 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 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 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. 8455472 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. 8501225 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. 8518929 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 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 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. 8551521 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. 8563608 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. 8617593 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 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. 8618166 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. 8623406 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 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. 8669245 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. 8680144 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 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. 8703185 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 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. 8710041 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. 9198892 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. 9603826 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 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 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 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 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 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. 9700537 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. 9918954 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. 10010517 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. 10265287 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. 10278935 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 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 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 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 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 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 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 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
Pat. No. 10668042 Methods of reducing the risk of cardiovascular events in a subject
Claim Types: Method of use
Pat. Sub. Date(s): 001: Jun 26, 2020
Jun 28, 2033U-2841: 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
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.
Last edited: 17 September 2020
© 2001-2020 Bruce A. Pokras, All rights reserved worldwide