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- Patent information is published on or after the submission date as defined in 21 CFR 314.53(d)(5).
- Patent listings published prior to August 18, 2003, only identify method-of-use claims. The listed patents may include drug substance and/or drug product claims that are not indicated in the listing.
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Patent and Exclusivity for: N202057
Product 001
ICOSAPENT ETHYL (VASCEPA) CAPSULE 1GM
Patent Data
Product No | Patent No | Patent Expiration | Drug Substance | Drug Product | Patent Use Code | Delist Requested | Submission Date |
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001 | 8293727 | 02/09/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
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001 | 8293728 | 02/09/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
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001 | 8298554 | 04/29/2030 | DP |
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001 | 8314086 | 02/09/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
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001 | 8318715 | 02/09/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
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11/29/2012 | |||
001 | 8357677 | 02/09/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
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001 | 8367652 | 02/09/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
|
02/07/2013 | |||
001 | 8377920 | 02/09/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
|
||||
001 | 8399446 | 02/09/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
|
04/17/2013 | |||
001 | 8410086 | 06/15/2030 |
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
|
01/06/2020 | |||
001 | 8415335 | 02/09/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
|
04/17/2013 | |||
001 | 8426399 | 02/09/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
|
||||
001 | 8431560 | 02/09/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
|
||||
001 | 8440650 | 02/09/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
|
||||
001 | 8445003 | 04/29/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
|
||||
001 | 8445013 | 04/29/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
|
||||
001 | 8454994 | 04/29/2030 |
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
|
01/06/2020 | |||
001 | 8455472 | 06/15/2030 |
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
|
01/06/2020 | |||
001 | 8501225 | 04/29/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
|
||||
001 | 8518929 | 02/09/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
|
||||
001 | 8524698 | 02/09/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
|
09/11/2013 | |||
001 | 8546372 | 02/09/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
|
10/01/2013 | |||
001 | 8551521 | 04/29/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
|
10/09/2013 | |||
001 | 8563608 | 04/29/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
|
10/22/2013 | |||
001 | 8617593 | 04/29/2030 |
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
|
01/14/2014 | |||
001 | 8617594 | 04/29/2030 |
U-1287
METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
|
||||
001 | 8618166 | 04/29/2030 |
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
|
01/06/2020 | |||
001 | 8623406 | 04/29/2030 |
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
|
01/14/2014 | |||
001 | 8642077 | 04/29/2030 |
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
|
01/06/2020 | |||
001 | 8669245 | 06/15/2030 |
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
|
01/06/2020 | |||
001 | 8680144 | 02/09/2030 |
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
|
01/06/2020 | |||
001 | 8691871 | 04/29/2030 |
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
|
01/06/2020 | |||
001 | 8703185 | 04/29/2030 |
U-2691
USE OF VASCEPA TO TREAT HYPERTRIGLYCERIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
|
01/06/2020 | |||
001 | 8709475 | 04/29/2030 |
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
|
01/06/2020 | |||
001 | 8710041 | 06/15/2030 |
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
|
01/06/2020 | |||
001 | 9198892 | 09/25/2027 |
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
|
01/10/2020 | |||
001 | 9603826 | 06/28/2033 |
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)
|
01/06/2020 | |||
001 | 9610272 | 06/28/2033 |
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)
|
01/06/2020 | |||
001 | 9623001 | 06/28/2033 |
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)
|
01/06/2020 | |||
001 | 9693984 | 06/28/2033 |
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)
|
01/06/2020 | |||
001 | 9693985 | 06/28/2033 |
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)
|
01/06/2020 | |||
001 | 9693986 | 06/28/2033 |
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)
|
01/06/2020 | |||
001 | 9700537 | 05/31/2027 |
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
|
01/10/2020 | |||
001 | 9918954 | 06/28/2033 |
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
|
01/06/2020 | |||
001 | 10010517 | 04/29/2030 |
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
|
01/06/2020 | |||
001 | 10265287 | 04/29/2030 |
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
|
01/06/2020 | |||
001 | 10278935 | 06/28/2033 |
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)
|
01/06/2020 | |||
001 | 10278936 | 06/28/2033 |
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
|
01/06/2020 | |||
001 | 10278937 | 06/28/2033 |
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
|
01/06/2020 | |||
001 | 10383840 | 06/28/2033 |
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
|
01/06/2020 | |||
001 | 10555924 | 06/28/2033 |
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
|
02/26/2020 | |||
001 | 10555925 | 06/28/2033 |
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
|
02/26/2020 | |||
001 | 10568861 | 06/28/2033 |
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
|
03/20/2020 | |||
001 | 10576054 | 06/28/2033 |
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
|
03/27/2020 | |||
001 | 10668042 | 06/28/2033 |
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
|
06/26/2020 | |||
001 | 10786478 | 06/28/2033 |
U-2959
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
U-2960
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
|
10/16/2020 | |||
001 | 10792267 | 04/29/2030 |
U-2961
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
|
10/16/2020 | |||
001 | 10792270 | 06/28/2033 |
U-2962
USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CORONARY REVASCULARIZATION IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
|
10/16/2020 | |||
001 | 10842766 | 04/29/2030 |
U-2997
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
|
12/11/2020 | |||
001 | 10842768 | 06/15/2030 |
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
|
12/11/2020 | |||
001 | 10881632 | 04/29/2030 |
U-3052
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
|
02/04/2021 | |||
001 | 10894028 | 06/28/2033 |
U-3053
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
|
02/04/2021 |
Exclusivity Data
Product No | Exclusivity Code | Exclusivity Expiration |
---|---|---|
001 |
I-819ADJUNCT 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
COMPETITIVE GENERIC THERAPY
|
12/13/2022 |
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