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Icosapent Ethyl Patent Expiration

Icosapent Ethyl is Used for reducing the risk of cardiovascular events in adult patients with elevated triglyceride levels as an adjunct to statin therapy. It was first introduced by Amarin Pharmaceuticals Ireland Ltd in its drug Vascepa on Jul 26, 2012. 11 different companies have introduced drugs containing Icosapent Ethyl.


Icosapent Ethyl Patents

Given below is the list of patents protecting Icosapent Ethyl, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Vascepa US10278935 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Jun 28, 2033 Amarin Pharms
Vascepa US10278936 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Jun 28, 2033 Amarin Pharms
Vascepa US10278937 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Jun 28, 2033 Amarin Pharms
Vascepa US10383840 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Jun 28, 2033 Amarin Pharms
Vascepa US10555924 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Jun 28, 2033 Amarin Pharms
Vascepa US10555925 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Jun 28, 2033 Amarin Pharms
Vascepa US10568861 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Jun 28, 2033 Amarin Pharms
Vascepa US10576054 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Jun 28, 2033 Amarin Pharms
Vascepa US10668042 Methods of reducing the risk of cardiovascular events in a subject Jun 28, 2033 Amarin Pharms
Vascepa US10786478 Methods of reducing the risk of cardiovascular events in a subject Jun 28, 2033 Amarin Pharms
Vascepa US10792270 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Jun 28, 2033 Amarin Pharms
Vascepa US10894028 Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease Jun 28, 2033 Amarin Pharms
Vascepa US11000499 Methods of reducing the risk of cardiovascular events in a subject Jun 28, 2033 Amarin Pharms
Vascepa US11116742 Methods of reducing the risk of cardiovascular events in a subject Jun 28, 2033 Amarin Pharms
Vascepa US11298333 Methods of reducing the risk of cardiovascular events in a subject Jun 28, 2033 Amarin Pharms
Vascepa US11369582 Methods of reducing the risk of cardiovascular events in a subject Jun 28, 2033 Amarin Pharms
Vascepa US9603826 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Jun 28, 2033 Amarin Pharms
Vascepa US9610272 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Jun 28, 2033 Amarin Pharms
Vascepa US9623001 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Jun 28, 2033 Amarin Pharms
Vascepa US9693984 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Jun 28, 2033 Amarin Pharms
Vascepa US9693985 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Jun 28, 2033 Amarin Pharms
Vascepa US9693986 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Jun 28, 2033 Amarin Pharms
Vascepa US9918954 Methods of reducing the risk of a cardiovascular event in a subject on statin therapy Jun 28, 2033 Amarin Pharms
Vascepa US10842768 Compositions and methods for lowering triglycerides Jun 15, 2030 Amarin Pharms
Vascepa US8410086 Compositions and methods for lowering triglycerides Jun 15, 2030 Amarin Pharms
Vascepa US8455472 Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy Jun 15, 2030 Amarin Pharms
Vascepa US8669245 Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy Jun 15, 2030 Amarin Pharms
Vascepa US8710041 Compositions and methods for lowering triglycerides in a subject on concomitant statin therapy Jun 15, 2030 Amarin Pharms
Vascepa US10010517 Stable pharmaceutical composition and methods of using same Apr 29, 2030 Amarin Pharms
Vascepa US10265287 Methods of reducing triglycerides and LDL-C Apr 29, 2030 Amarin Pharms
Vascepa US10792267 Methods of treating mixed dyslipidemia Apr 29, 2030 Amarin Pharms
Vascepa US10842766 Stable pharmaceutical composition and methods of using same Apr 29, 2030 Amarin Pharms
Vascepa US10881632 Stable pharmaceutical composition and methods of using same Apr 29, 2030 Amarin Pharms
Vascepa US11103477 Stable pharmaceutical composition and methods of using same Apr 29, 2030 Amarin Pharms
Vascepa US11154526 Methods of treating mixed dyslipidemia Apr 29, 2030 Amarin Pharms
Vascepa US11213504 Stable pharmaceutical composition and methods of using same Apr 29, 2030 Amarin Pharms
Vascepa US11717504 Methods of reducing the risk of cardiovascular events in a subject Apr 29, 2030 Amarin Pharms
Vascepa US8298554 Stable pharmaceutical composition and methods of using same Apr 29, 2030 Amarin Pharms
Vascepa US8445003 Stable pharmaceutical composition and methods of using same Apr 29, 2030 Amarin Pharms
Vascepa US8445013 Stable pharmaceutical composition and methods of using same Apr 29, 2030 Amarin Pharms
Vascepa US8454994 Stable pharmaceutical composition and methods of using same Apr 29, 2030 Amarin Pharms
Vascepa US8501225 Stable pharmaceutical composition and methods of using same Apr 29, 2030 Amarin Pharms
Vascepa US8551521 Stable pharmaceutical composition and methods of using same Apr 29, 2030 Amarin Pharms
Vascepa US8563608 Methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy Apr 29, 2030 Amarin Pharms
Vascepa US8617593 Stable pharmaceutical composition and methods of using same Apr 29, 2030 Amarin Pharms
Vascepa US8617594 Stable pharmaceutical composition and methods of using same Apr 29, 2030 Amarin Pharms
Vascepa US8618166 Methods of treating mixed dyslipidemia Apr 29, 2030 Amarin Pharms
Vascepa US8623406 Stable pharmaceutical composition and methods of using same Apr 29, 2030 Amarin Pharms
Vascepa US8642077 Stable pharmaceutical composition and methods of using same Apr 29, 2030 Amarin Pharms
Vascepa US8691871 Methods of treating mixed dyslipidemia Apr 29, 2030 Amarin Pharms
Vascepa US8703185 Stable pharmaceutical composition and methods of using same Apr 29, 2030 Amarin Pharms
Vascepa US8709475 Stable pharmaceutical composition and methods of using same Apr 29, 2030 Amarin Pharms
Vascepa US12171738 Compositions and methods for lowering triglycerides Feb 09, 2030 Amarin Pharms
Vascepa US8293727 Methods of treating hypertriglyceridemia Feb 09, 2030 Amarin Pharms
Vascepa US8293728 Methods of treating hypertriglyceridemia Feb 09, 2030 Amarin Pharms
Vascepa US8314086 Methods of treating hypertriglyceridemia Feb 09, 2030 Amarin Pharms
Vascepa US8318715 Methods of treating hypertriglyceridemia Feb 09, 2030 Amarin Pharms
Vascepa US8357677 Methods of treating hypertriglyceridemia Feb 09, 2030 Amarin Pharms
Vascepa US8367652 Methods of treating hypertriglyceridemia Feb 09, 2030 Amarin Pharms
Vascepa US8377920 Methods of treating hypertriglyceridemia Feb 09, 2030 Amarin Pharms
Vascepa US8399446 Methods of treating hypertriglyceridemia Feb 09, 2030 Amarin Pharms
Vascepa US8415335 Methods of treating hypertriglyceridemia Feb 09, 2030 Amarin Pharms
Vascepa US8426399 Methods of treating hypertriglyceridemia Feb 09, 2030 Amarin Pharms
Vascepa US8431560 Methods of treating hypertriglyceridemia Feb 09, 2030 Amarin Pharms
Vascepa US8440650 Methods of treating hypertriglyceridemia Feb 09, 2030 Amarin Pharms
Vascepa US8518929 Methods of treating hypertriglyceridemia Feb 09, 2030 Amarin Pharms
Vascepa US8524698 Methods of treating hypertriglyceridemia Feb 09, 2030 Amarin Pharms
Vascepa US8546372 Methods of treating hypertriglyceridemia Feb 09, 2030 Amarin Pharms
Vascepa US8680144 Methods of treating mixed dyslipidemia Feb 09, 2030 Amarin Pharms
Vascepa US9198892 Composition and/or method for preventing onset and/or recurrence of cardiovascular events Sep 25, 2027 Amarin Pharms
Vascepa US9700537 Composition for preventing the occurrence of cardiovascular event in multiple risk patient May 31, 2027 Amarin Pharms
Vascepa US8188146 Highly purified ethyl EPA and other EPA derivatives Jan 27, 2020

(Expired)

 Amarin Pharms
Vascepa US8188146 Highly purified ethyl EPA and other EPA derivatives Jan 27, 2020

(Expired)

 Amarin Pharms



A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Icosapent Ethyl's patents.

Given below is the list recent legal activities going on the following patents of Icosapent Ethyl.

Activity Date Patent Number
Patent litigations
Maintenance Fee Reminder Mailed
Critical
 15 Jul, 2024 US8318715(Litigated)
Maintenance Fee Reminder Mailed
Critical
 08 Jul, 2024 US8314086
Payment of Maintenance Fee, 4th Year, Large Entity 03 Jul, 2024 US10894028
Expire Patent
Critical
 01 Jul, 2024 US8188146
Payment of Maintenance Fee, 4th Year, Large Entity 19 Jun, 2024 US10881632
Maintenance Fee Reminder Mailed
Critical
 10 Jun, 2024 US8293727
Maintenance Fee Reminder Mailed
Critical
 10 Jun, 2024 US8293728(Litigated)
Payment of Maintenance Fee, 4th Year, Large Entity 08 May, 2024 US10842766
Payment of Maintenance Fee, 4th Year, Large Entity 08 May, 2024 US10842768
Payment of Maintenance Fee, 12th Year, Large Entity 17 Apr, 2024 US8298554


Icosapent Ethyl's Family Patents

Family Patents

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Icosapent Ethyl Generic API Manufacturers

Several generic applications have been filed for Icosapent Ethyl. The first generic version for Icosapent Ethyl was by Hikma Pharmaceuticals Usa Inc and was approved on May 21, 2020. And the latest generic version is by Spriaso Llc and was approved on Dec 20, 2024.

Given below is the list of companies who have filed for Icosapent Ethyl generic, along with the locations of their manufacturing plants worldwide.


1. APOTEX

Apotex Inc has filed for 1 generic for Icosapent Ethyl. Given below are the details of the strengths of this generic introduced by Apotex.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM

capsule Prescription ORAL AB Jun 30, 2021


Manufacturing Plant Locations
New

Apotex's manufacturing plants are situated in 3 countries - United States, Canada, India. Given below are the details of these plant locations as well as the firm names of Apotex as present at those locations.

Country City Firm Name
United States
Weston Apotex Corp.
Canada
Toronto Apotex Inc.
Brantford Apotex Pharmachem Inc.
North York Apotex Inc.
Winnipeg Apotex Fermentation Inc.
Etobicoke Apotex, Inc.
Richmond Hill Apotex Inc.
India
Bangalore Apotex Pharmachem India Pvt Ltd.
Bengaluru Apotex Research Private Limited
Bangalore Apotex Research Private Limited - Bioequivalence Centre





2. ASCENT PHARMS INC

Ascent Pharmaceuticals Inc has filed for 2 different strengths of generic version for Icosapent Ethyl. Given below are the details of the strengths of this generic introduced by Ascent Pharms Inc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

capsule Prescription ORAL AB Dec 7, 2023
1GM

capsule Prescription ORAL AB Feb 16, 2024





3. DR REDDYS

Dr Reddys Laboratories Inc has filed for 2 different strengths of generic version for Icosapent Ethyl. Given below are the details of the strengths of this generic introduced by Dr Reddys.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM

capsule Prescription ORAL AB Aug 7, 2020
500MG

capsule Prescription ORAL AB Mar 8, 2023





4. HIKMA

Hikma Pharmaceuticals Usa Inc has filed for 2 different strengths of generic version for Icosapent Ethyl. Given below are the details of the strengths of this generic introduced by Hikma.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM

capsule Prescription ORAL AB May 21, 2020
500MG

capsule Prescription ORAL AB Mar 8, 2023


Manufacturing Plant Locations
New

Hikma's manufacturing plants are situated in 3 countries - United States, Portugal, Jordan. Given below are the details of these plant locations as well as the firm names of Hikma as present at those locations.

Country City Firm Name
United States
Eatontown Hikma Pharmaceuticals USA, Inc.
Cherry Hill Hikma Pharmaceuticals USA Inc.
Carlsbad Hikma Cali Inc. DBA Leucadia Pharmaceuticals
Dayton Hikma Injectables USA Inc
Portugal
Terrugem Snt Hikma Farmaceutica, (Portugal) S.A.
Jordan
Amman Hikma Pharmaceuticals LLC





5. HUMANWELL PURACAP

Humanwell Puracap Pharmaceutical Wuhan Co Ltd has filed for 2 different strengths of generic version for Icosapent Ethyl. Given below are the details of the strengths of this generic introduced by Humanwell Puracap.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

capsule Prescription ORAL AB Dec 22, 2023
1GM

capsule Prescription ORAL AB Dec 22, 2023


Manufacturing Plant Locations
New

Humanwell Puracap's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Humanwell Puracap as present at those locations.

Country City Firm Name
China
Wuhan Humanwell PuraCap Pharmaceuticals (Wuhan) Co., Ltd.





6. QILU

Qilu Pharmaceutical Co Ltd has filed for 1 generic for Icosapent Ethyl. Given below are the details of the strengths of this generic introduced by Qilu.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM

capsule Prescription ORAL AB Nov 20, 2024


Manufacturing Plant Locations
New

Qilu's manufacturing plants are situated in 1 country - China. Given below are the details of these plant locations as well as the firm names of Qilu as present at those locations.

Country City Firm Name
China
Dezhou Qilu SYNVA Pharmaceutical Co. Ltd
Jinan Qilu Pharmaceutical Co., Ltd. (High Tech Zone Site)
Haikou Qilu Pharmaceutical (Hainan) Co. Ltd.
Hulunbeier Qilu Pharmaceutical Hulun Buir Branch
Hohhot Qilu Pharmaceutical (Inner Mongolia) Co., Ltd.
Jinan Qilu Antibiotics Pharmaceutical Co. , Ltd.
Jinan Qilu Pharmaceutical Co., Ltd.





7. SPRIASO LLC

Spriaso Llc has filed for 1 generic for Icosapent Ethyl. Given below are the details of the strengths of this generic introduced by Spriaso Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM

capsule Prescription ORAL AB Dec 20, 2024





8. STRIDES SOFTGELS

Strides Softgels Pte Ltd has filed for 2 different strengths of generic version for Icosapent Ethyl. Given below are the details of the strengths of this generic introduced by Strides Softgels.

Strength Dosage Form Availability Application Pathway TE code Launch Date
500MG

capsule Prescription ORAL AB Sep 22, 2023
1GM

capsule Prescription ORAL AB Sep 22, 2023





9. TEVA PHARMS USA

Teva Pharmaceuticals Usa has filed for 2 different strengths of generic version for Icosapent Ethyl. Given below are the details of the strengths of this generic introduced by Teva Pharms Usa.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM

capsule Prescription ORAL AB Sep 11, 2020
500MG

capsule Prescription ORAL AB Sep 11, 2020





10. ZYDUS LIFESCIENCES

Zydus Lifesciences Global Fze has filed for 2 different strengths of generic version for Icosapent Ethyl. Given below are the details of the strengths of this generic introduced by Zydus Lifesciences.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1GM

capsule Prescription ORAL AB Apr 20, 2023
500MG

capsule Prescription ORAL AB Apr 20, 2023


Manufacturing Plant Locations
New

Zydus Lifesciences's manufacturing plants are situated in 1 country - India. Given below are the details of these plant locations as well as the firm names of Zydus Lifesciences as present at those locations.

Country City Firm Name
India
Thane Zydus Lifesciences Limited
Jarod Zydus Lifesciences Limited
Ahmedabad ZYDUS LIFESCIENCES LIMITED
Ahmedabad Zydus Lifesciences Limited
Dabhasa Zydus Lifesciences Limited
District Solan Zydus Lifesciences Limited
Moraiya, Ahmedabad Zydus Lifesciences Limited
Ankleshwar Zydus Lifesciences Limited
Matoda Zydus Lifesciences Limited