VASCEPA Drug Patent Profile
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When do Vascepa patents expire, and what generic alternatives are available?
Vascepa is a drug marketed by Amarin Pharms and is included in one NDA. There are sixty-nine patents protecting this drug and two Paragraph IV challenges.
This drug has three hundred and thirty-five patent family members in forty-four countries.
The generic ingredient in VASCEPA is icosapent ethyl. There are twelve drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Vascepa
A generic version of VASCEPA was approved as icosapent ethyl by HIKMA on May 21st, 2020.
Summary for VASCEPA
| International Patents: | 335 |
| US Patents: | 69 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 59 |
| Clinical Trials: | 16 |
| Patent Applications: | 1,943 |
| Drug Prices: | Drug price information for VASCEPA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VASCEPA |
| What excipients (inactive ingredients) are in VASCEPA? | VASCEPA excipients list |
| DailyMed Link: | VASCEPA at DailyMed |
Recent Clinical Trials for VASCEPA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 1/Phase 2 |
| St. Michael's Hospital, Toronto | Phase 4 |
| University of Western Ontario, Canada | Phase 4 |
Paragraph IV (Patent) Challenges for VASCEPA
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VASCEPA | Capsules | icosapent ethyl | 500 mg | 202057 | 1 | 2017-08-29 |
| VASCEPA | Capsules | icosapent ethyl | 1 g | 202057 | 4 | 2016-07-26 |
US Patents and Regulatory Information for VASCEPA
VASCEPA is protected by seventy-four US patents and one FDA Regulatory Exclusivity.
Patents protecting VASCEPA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of reducing triglycerides and LDL-C
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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)
Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF UNSTABLE ANGINA IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF STROKE IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CARDIOVASCULAR DEATH IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of reducing the risk of cardiovascular events in a subject
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of reducing the risk of cardiovascular events in a subject
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of reducing the risk of cardiovascular events in a subject
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of treating mixed dyslipidemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE RISK OF CORONARY REVASCULARIZATION IN AN ADULT PATIENT WITH ESTABLISHED CARDIOVASCULAR DISEASE
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Compositions and methods for lowering triglycerides
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of reducing the risk of cardiovascular events in a subject
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of reducing the risk of cardiovascular events in a subject
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of treating mixed dyslipidemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of reducing the risk of cardiovascular events in a subject
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of reducing the risk of cardiovascular events in a subject
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Compositions and methods for lowering triglycerides
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF VASCEPA TO TREAT MIXED DYSLIPIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>=150 MG/DL) AND ON STATIN THERAPY
Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT ON STATIN THERAPY SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF VASCEPA TO TREAT HYPERTRIGLYCERIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating mixed dyslipidemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF VASCEPA TO TREAT MIXED DYSLIPIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>=150 MG/DL) AND ON STATIN THERAPY
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF VASCEPA TO REDUCE TRIGLYCERIDES IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT ON STATIN THERAPY SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF VASCEPA TO REDUCE TRIGLYCERIDES IN A MIXED DYSLIPIDEMIA ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of treating mixed dyslipidemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF VASCEPA TO TREAT MIXED HYPERTRIGLYCERIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
Methods of treating mixed dyslipidemia
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF VASCEPA TO TREAT MIXED DYSLIPIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>=150 MG/DL) AND ON STATIN THERAPY
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF VASCEPA TO TREAT HYPERTRIGLYCERIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>= 150 MG/DL) AND ON STATIN THERAPY
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF VASCEPA TO TREAT MIXED DYSLIPIDEMIA IN AN ADULT PATIENT WITH ELEVATED TRIGLYCERIDE (TG) LEVELS (>=150 MG/DL) AND ON STATIN THERAPY
Compositions and methods for lowering triglycerides in a subject on concomitant statin therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Composition and/or method for preventing onset and/or recurrence of cardiovascular events
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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)
Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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)
Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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)
Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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)
Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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)
Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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)
Composition for preventing the occurrence of cardiovascular event in multiple risk patient
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: USE OF VASCEPA AS AN ADJUNCT TO STATIN THERAPY TO REDUCE THE OCCURRENCE OF A CARDIOVASCULAR EVENT IN AN ADULT PATIENT WITH HYPERCHOLESTEROLEMIA
Methods of reducing the risk of a cardiovascular event in a subject on statin therapy
Patent Number: ⤷ Try a Trial
Patent Expiration: ⤷ Try a Trial
Patented Use: 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
FDA Regulatory Exclusivity protecting VASCEPA
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
Exclusivity Expiration: ⤷ Try a Trial
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | Y | ⤷ Try a Trial | ||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | AB | RX | Yes | Yes | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | AB | RX | Yes | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
Expired US Patents for VASCEPA
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | ⤷ Try a Trial | ⤷ Try a Trial |
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | ⤷ Try a Trial | ⤷ Try a Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for VASCEPA
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Amarin Pharmaceuticals Ireland Limited | Vazkepa | icosapent ethyl | EMEA/H/C/005398 Indicated to reduce cardiovascular risk as an adjunct to statin therapy. |
Authorised | no | no | no | 2021-03-26 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for VASCEPA
See the table below for patents covering VASCEPA around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| South Africa | 201500040 | METHODS OF REDUCING THE RISK OF A CARDIOVASCULAR EVENT IN A SUBJECT ON STATIN THERAPY | ⤷ Try a Trial |
| Mexico | 2015000138 | METODOS PARA REDUCIR RIESGO DE EVENTO CARDIOVASCULAR EN SUJETO CON TERAPIA CON ESTATINA. (METHODS OF REDUCING THE RISK OF A CARDIOVASCULAR EVENT IN A SUBJECT ON STATIN THERAPY.) | ⤷ Try a Trial |
| Philippines | 12021500016 | METHODS OF REDUCING THE RISK OF CARDIOVASCULAR EVENTS IN A SUBJECT | ⤷ Try a Trial |
| Australia | 2023200781 | Methods of reducing the risk of cardiovascular events in a subject | ⤷ Try a Trial |
| Lithuania | 3363433 | ⤷ Try a Trial | |
| South Korea | 20110110321 | USE OF EICOSAPENTAENOIC ACID ETHYL ESTER FOR TREATING HYPERTRIGLYCERIDEMIA | ⤷ Try a Trial |
| Eurasian Patent Organization | 202190859 | СПОСОБЫ СНИЖЕНИЯ РИСКА СЕРДЕЧНО-СОСУДИСТЫХ СОБЫТИЙ У СУБЪЕКТА | ⤷ Try a Trial |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VASCEPA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2022495 | 122021000058 | Germany | ⤷ Try a Trial | PRODUCT NAME: ICOSAPENT-ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210326 |
| 2443246 | PA2021522 | Lithuania | ⤷ Try a Trial | PRODUCT NAME: IKOZAPENTO ETILAS; REGISTRATION NO/DATE: EU/1/20/1524 20210326 |
| 2022495 | 21C1045 | France | ⤷ Try a Trial | PRODUCT NAME: ICOSAPENT ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329 |
| 2443246 | CA 2021 00036 | Denmark | ⤷ Try a Trial | PRODUCT NAME: ICOSAPENT ETHYL; REG. NO/DATE: EU/1/20/1524 20210329 |
| 0253738 | 96C0009 | Belgium | ⤷ Try a Trial | PRODUCT NAME: CONCENTRE A 85 % D'OMEGA POLYINSATURES; QUANTITE CORRESPONDANT A :; ESTERS ETHYLIQUES D'ACIDE EICOSAPENTAENOIQUE (EPA) ET D'ACIDE DOCOSAHEXAENOIQUE (DHA); ALPHA TOCOPHEROL; NAT. REGISTRATION NO/DATE: NL 20819 19951002; FIRST REGISTRATION: |
| 2443246 | 21C1046 | France | ⤷ Try a Trial | PRODUCT NAME: ICOSAPENT ETHYL; NAT. REGISTRATION NO/DATE: EU/1/20/1524 20210329; FIRST REGISTRATION: - EU/1/20/1524 20210329 |
| 2022495 | C202130051 | Spain | ⤷ Try a Trial | PRODUCT NAME: ICOSAPENTO DE ETILO; NATIONAL AUTHORISATION NUMBER: EU/1/20/1524; DATE OF AUTHORISATION: 20210326; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/20/1524; DATE OF FIRST AUTHORISATION IN EEA: 20210326 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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