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-three patents protecting this drug and two Paragraph IV challenges.
This drug has three hundred and sixty-nine patent family members in forty-six countries.
The generic ingredient in VASCEPA is icosapent ethyl. There are twelve drug master file entries for this compound. Fifteen 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.
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Summary for VASCEPA
| International Patents: | 369 |
| US Patents: | 63 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 2 |
| Raw Ingredient (Bulk) Api Vendors: | 60 |
| Clinical Trials: | 16 |
| Patent Applications: | 950 |
| 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 |
| HLS Therapeutics, Inc | Phase 4 |
| Unity Health Toronto | 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 sixty-eight US patents.
Patents protecting VASCEPA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Subscribe
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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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
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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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: USE OF VASCEPA TO REDUCE THE INCIDENCE OF STROKE 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 STROKE
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Compositions and methods for lowering triglycerides
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating hypertriglyceridemia
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Methods of treating mixed dyslipidemia
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
Patented Use: METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
Stable pharmaceutical composition and methods of using same
Patent Number: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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
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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: ⤷ Subscribe
Patent Expiration: ⤷ Subscribe
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
| 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 | 202057-002 | Feb 16, 2017 | AB | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | AB | RX | Yes | No | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | AB | RX | Yes | Yes | ⤷ Subscribe | ⤷ Subscribe | ⤷ Subscribe | |||
| >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 | ⤷ Subscribe | ⤷ Subscribe |
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | ⤷ Subscribe | ⤷ Subscribe |
| >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 |
|---|---|---|---|
| Australia | 2019349563 | Methods of reducing the risk of cardiovascular events in a subject | ⤷ Subscribe |
| European Patent Office | 4338805 | PROCÉDÉS DE RÉDUCTION DU RISQUE D'UN ÉVÉNEMENT CARDIOVASCULAIRE CHEZ UN SUJET SOUMIS À UN TRAITEMENT PAR UNE STATINE (METHODS OF REDUCING THE RISK OF A CARDIOVASCULAR EVENT IN A SUBJECT ON STATIN THERAPY) | ⤷ Subscribe |
| Russian Federation | 2011148363 | ФАРМАЦЕВТИЧЕСКИЕ КОМПОЗИЦИИ, СОДЕРЖАЩИЕ ЕРА И СЕРДЕЧНО-СОСУДИСТОЕ СРЕДСТВО, И СПОСОБ ИХ ПРИМЕНЕНИЯ | ⤷ Subscribe |
| Japan | 2008050367 | COMPOSITION FOR PREVENTING CARDIOVASCULAR EVENT DEVELOPMENT | ⤷ Subscribe |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VASCEPA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2443246 | PA2021522 | Lithuania | ⤷ Subscribe | PRODUCT NAME: IKOZAPENTO ETILAS; REGISTRATION NO/DATE: EU/1/20/1524 20210326 |
| 2443246 | C202130052 | Spain | ⤷ Subscribe | 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 |
| 0253738 | 96C0009 | Belgium | ⤷ Subscribe | 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 | 2021042 | Norway | ⤷ Subscribe | PRODUCT NAME: IKOSAPENTETYL; REG. NO/DATE: EU/1/20/1524 20210408 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Market Dynamics and Financial Trajectory for VASCEPA
Introduction
VASCEPA, a highly purified eicosapentaenoic acid (EPA) drug developed by Amarin, has been a significant player in the omega-3 prescription drugs market. Here, we delve into the current market dynamics and the financial trajectory of VASCEPA, especially in the context of generic competition and global expansion.
Market Position of VASCEPA
VASCEPA holds a dominant position in the omega-3 prescription drugs market, anticipated to capture around 47.7% of the market share during the forecast period. This dominance is largely due to its FDA approval and established preference for reducing cardiovascular risks among patients with high triglyceride levels[4].
Impact of Generic Competition in the U.S.
The launch of generic versions of icosapent ethyl in the United States has significantly impacted VASCEPA's revenue. Generic companies typically do not invest in market education or expansion, and the manufacturing of icosapent ethyl is challenging and expensive, leading to limited supply capacity and lower gross margins for generics. Despite this, Amarin has seen a decline in U.S. net product revenue, primarily due to a drop in the net selling price and the loss of exclusive commercial accounts[1][2][5].
Financial Performance
In the second quarter of 2024, Amarin reported a total net revenue of $67.5 million, a 16% decrease year-over-year. The U.S. net product revenue declined by 32% due to generic competition. The company's gross margin on net product revenue decreased to 48% from 64% in the same period of 2023. However, Amarin maintained a strong cash position of $307 million, providing financial stability[2].
In the third quarter of 2024, total net revenue further decreased to $42.3 million, down 36% from the corresponding period in 2023. This decline was driven by the impact of generic competition on the net selling price and a decrease in volume, particularly due to CVS no longer covering VASCEPA as an exclusive product[5].
Global Expansion and Regulatory Approvals
Despite the challenges in the U.S. market, Amarin is focusing on global expansion to offset revenue declines. The company has received regulatory approval for VASCEPA in China for cardiovascular risk reduction and secured national reimbursement for VAZKEPA in Portugal and Greece. These developments are crucial for Amarin's future growth trajectory[2][3].
Strategic Adjustments
Amarin is adjusting its approach to accommodate changes in market dynamics. The company continues robust sales and marketing efforts to maintain VASCEPA as a prioritized area of focus and a significant source of revenue. Amarin also explores ways to increase awareness and education about VASCEPA, particularly in the context of COVID-19 restrictions[1].
Leadership and Operational Efficiency
The company has completed a leadership transition with Aaron Berg appointed as President and CEO. Amarin has also realized significant annual savings of $50 million from its 2023 restructuring efforts, which has helped in maintaining operational efficiency[2].
Clinical Research and Market Education
Amarin continues to invest in clinical research, such as pilot studies exploring VASCEPA's potential in improving patient care during the COVID-19 pandemic. New research presented at the 60th Annual European Association for the Study of Diabetes (EASD) Meeting highlights the clinical impact of VASCEPA/VAZKEPA in patients with diabetes and high cardiovascular risk[5].
Distribution Channels and Market Dynamics
The retail pharmacy segment is expected to hold more than 52.3% of the omega-3 prescription drugs market share by 2037, driven by increasing convenience and accessibility. This trend, along with the adoption of e-prescriptions and telehealth services, is likely to drive sales of omega-3 prescription drugs, including VASCEPA, in retail settings[4].
Key Takeaways
- Generic Competition: The launch of generic icosapent ethyl in the U.S. has impacted VASCEPA's revenue, but Amarin's robust marketing efforts and limited generic supply capacity help maintain market presence.
- Global Expansion: Regulatory approvals in China, Portugal, and Greece are key to offsetting U.S. revenue declines.
- Financial Stability: Amarin maintains a strong cash position despite revenue declines.
- Operational Efficiency: Restructuring efforts have resulted in significant annual savings.
- Clinical Research: Ongoing research highlights VASCEPA's clinical benefits, supporting its market position.
FAQs
What is the impact of generic competition on VASCEPA's revenue in the U.S.?
The launch of generic icosapent ethyl in the U.S. has led to a decline in VASCEPA's revenue, primarily due to a drop in the net selling price and the loss of exclusive commercial accounts.
How is Amarin addressing the challenges posed by generic competition?
Amarin continues robust sales and marketing efforts to maintain VASCEPA as a prioritized area of focus. The company also focuses on global expansion and clinical research to support its market position.
What are the key global markets for VASCEPA's expansion?
Amarin is focusing on expansion in China, Europe, Portugal, and Greece, where regulatory approvals and national reimbursements have been secured.
How has Amarin's financial performance been affected by generic competition?
Total net revenue has declined due to generic competition, but Amarin maintains a strong cash position and has realized significant savings from restructuring efforts.
What are the future growth prospects for VASCEPA?
Amarin's future growth is expected to be driven by global expansion, particularly in China and Europe, along with ongoing clinical research and market education efforts.
Sources
- Amarin's plan for operations now that generic versions of icosapent ethyl have launched in the United States. Amarin Corporation.
- Amarin Reports Second Quarter 2024 Financial Results and Provides Business Update. Stock Titan.
- Earnings call: Amarin reports Q2 2024 results, eyes global VASCEPA expansion. Investing.com.
- Omega-3 Prescription Drugs Market Market Analysis. Research Nester.
- Amarin Reports Third Quarter 2024 Financial Results and Provides Business Update. GlobeNewswire.
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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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