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)
| Patents | Expiration | Patented 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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | U-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, 2030 | 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. 8709475 Stable pharmaceutical composition and methods of using same Claim Types: Method of use Pat. Sub. Date(s): 001: Jan 6, 2020 | Apr 29, 2030 | U-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, 2030 | U-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, 2027 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2027 | U-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, 2033 | U-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, 2030 | U-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, 2030 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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, 2033 | U-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 |
| Exclusivity | Expiration | Exclusivity Description |
| Exclusivity Code: I - New Indication | Dec 13, 2022 | I-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 |