Vascepa is a drug owned by Amarin Pharmaceuticals Ireland Ltd. It is protected by 72 US drug patents filed from 2013 to 2025. Out of these, 71 drug patents are active and 1 has expired. Vascepa's patents have been open to challenges since 26 July, 2016. Based on its patents and exclusivities, its generic launch date is estimated to be Jun 28, 2033. Details of Vascepa's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8188146 | Highly purified ethyl EPA and other EPA derivatives |
Jan, 2020
(5 years ago) |
Expired
|
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US11116742 | Methods of reducing the risk of cardiovascular events in a subject |
Jun, 2033
(8 years from now) | Active |
| US10568861 | Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease |
Jun, 2033
(8 years from now) | Active |
| US11000499 | Methods of reducing the risk of cardiovascular events in a subject |
Jun, 2033
(8 years from now) | Active |
| US10894028 | Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease |
Jun, 2033
(8 years from now) | Active |
| US10786478 | Methods of reducing the risk of cardiovascular events in a subject |
Jun, 2033
(8 years from now) | Active |
| US10792270 | Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease |
Jun, 2033
(8 years from now) | Active |
| US10278935 | Methods of reducing the risk of a cardiovascular event in a subject on statin therapy |
Jun, 2033
(8 years from now) | Active |
| US11298333 | Methods of reducing the risk of cardiovascular events in a subject |
Jun, 2033
(8 years from now) | Active |
| US11369582 | Methods of reducing the risk of cardiovascular events in a subject |
Jun, 2033
(8 years from now) | Active |
| US9603826 | Methods of reducing the risk of a cardiovascular event in a subject on statin therapy |
Jun, 2033
(8 years from now) | Active |
| US9623001 | Methods of reducing the risk of a cardiovascular event in a subject on statin therapy |
Jun, 2033
(8 years from now) | Active |
| US10383840 | Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease |
Jun, 2033
(8 years from now) | Active |
| US10576054 | Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease |
Jun, 2033
(8 years from now) | Active |
| US10668042 | Methods of reducing the risk of cardiovascular events in a subject |
Jun, 2033
(8 years from now) | Active |
| US10555925 | Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease |
Jun, 2033
(8 years from now) | Active |
| US10555924 | Methods of reducing the risk of a cardiovascular event in a subject at risk for cardiovascular disease |
Jun, 2033
(8 years from now) | Active |
| US9693984 | Methods of reducing the risk of a cardiovascular event in a subject on statin therapy |
Jun, 2033
(8 years from now) | Active |
| US9693985 | Methods of reducing the risk of a cardiovascular event in a subject on statin therapy |
Jun, 2033
(8 years from now) | Active |
| US9693986 | Methods of reducing the risk of a cardiovascular event in a subject on statin therapy |
Jun, 2033
(8 years from now) | Active |
| US10278937 | Methods of reducing the risk of a cardiovascular event in a subject on statin therapy |
Jun, 2033
(8 years from now) | Active |
| US9918954 | Methods of reducing the risk of a cardiovascular event in a subject on statin therapy |
Jun, 2033
(8 years from now) | Active |
| US10278936 | Methods of reducing the risk of a cardiovascular event in a subject on statin therapy |
Jun, 2033
(8 years from now) | Active |
| US9610272 | Methods of reducing the risk of a cardiovascular event in a subject on statin therapy |
Jun, 2033
(8 years from now) | Active |
| US8410086 | Compositions and methods for lowering triglycerides |
Jun, 2030
(5 years from now) | Active |
| US8669245 | Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy |
Jun, 2030
(5 years from now) | Active |
| US10842768 | Compositions and methods for lowering triglycerides |
Jun, 2030
(5 years from now) | Active |
| US8455472 | Compositions and methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy |
Jun, 2030
(5 years from now) | Active |
| US8710041 | Compositions and methods for lowering triglycerides in a subject on concomitant statin therapy |
Jun, 2030
(5 years from now) | Active |
| US8445013 | Stable pharmaceutical composition and methods of using same |
Apr, 2030
(4 years from now) | Active |
| US8501225 | Stable pharmaceutical composition and methods of using same |
Apr, 2030
(4 years from now) | Active |
| US8618166 | Methods of treating mixed dyslipidemia |
Apr, 2030
(4 years from now) | Active |
| US8623406 | Stable pharmaceutical composition and methods of using same |
Apr, 2030
(4 years from now) | Active |
| US8642077 | Stable pharmaceutical composition and methods of using same |
Apr, 2030
(4 years from now) | Active |
| US8703185 | Stable pharmaceutical composition and methods of using same |
Apr, 2030
(4 years from now) | Active |
| US8691871 | Methods of treating mixed dyslipidemia |
Apr, 2030
(4 years from now) | Active |
| US8709475 | Stable pharmaceutical composition and methods of using same |
Apr, 2030
(4 years from now) | Active |
| US10010517 | Stable pharmaceutical composition and methods of using same |
Apr, 2030
(4 years from now) | Active |
| US8563608 | Methods for lowering triglycerides without raising LDL-C levels in a subject on concomitant statin therapy |
Apr, 2030
(4 years from now) | Active |
| US11154526 | Methods of treating mixed dyslipidemia |
Apr, 2030
(4 years from now) | Active |
| US8454994 | Stable pharmaceutical composition and methods of using same |
Apr, 2030
(4 years from now) | Active |
| US8617593 | Stable pharmaceutical composition and methods of using same |
Apr, 2030
(4 years from now) | Active |
| US8551521 | Stable pharmaceutical composition and methods of using same |
Apr, 2030
(4 years from now) | Active |
| US8617594 | Stable pharmaceutical composition and methods of using same |
Apr, 2030
(4 years from now) | Active |
| US11717504 | Methods of reducing the risk of cardiovascular events in a subject |
Apr, 2030
(4 years from now) | Active |
| US10792267 | Methods of treating mixed dyslipidemia |
Apr, 2030
(4 years from now) | Active |
| US10842766 | Stable pharmaceutical composition and methods of using same |
Apr, 2030
(4 years from now) | Active |
| US10881632 | Stable pharmaceutical composition and methods of using same |
Apr, 2030
(4 years from now) | Active |
| US8445003 | Stable pharmaceutical composition and methods of using same |
Apr, 2030
(4 years from now) | Active |
| US11103477 | Stable pharmaceutical composition and methods of using same |
Apr, 2030
(4 years from now) | Active |
| US11213504 | Stable pharmaceutical composition and methods of using same |
Apr, 2030
(4 years from now) | Active |
| US8298554 | Stable pharmaceutical composition and methods of using same |
Apr, 2030
(4 years from now) | Active |
| US10265287 | Methods of reducing triglycerides and LDL-C |
Apr, 2030
(4 years from now) | Active |
| US8680144 | Methods of treating mixed dyslipidemia |
Feb, 2030
(4 years from now) | Active |
| US8318715 | Methods of treating hypertriglyceridemia |
Feb, 2030
(4 years from now) | Active |
| US8415335 | Methods of treating hypertriglyceridemia |
Feb, 2030
(4 years from now) | Active |
| US8314086 | Methods of treating hypertriglyceridemia |
Feb, 2030
(4 years from now) | Active |
| US8293728 | Methods of treating hypertriglyceridemia |
Feb, 2030
(4 years from now) | Active |
| US8518929 | Methods of treating hypertriglyceridemia |
Feb, 2030
(4 years from now) | Active |
| US8377920 | Methods of treating hypertriglyceridemia |
Feb, 2030
(4 years from now) | Active |
| US8440650 | Methods of treating hypertriglyceridemia |
Feb, 2030
(4 years from now) | Active |
| US8367652 | Methods of treating hypertriglyceridemia |
Feb, 2030
(4 years from now) | Active |
| US8431560 | Methods of treating hypertriglyceridemia |
Feb, 2030
(4 years from now) | Active |
| US8524698 | Methods of treating hypertriglyceridemia |
Feb, 2030
(4 years from now) | Active |
| US8399446 | Methods of treating hypertriglyceridemia |
Feb, 2030
(4 years from now) | Active |
| US8426399 | Methods of treating hypertriglyceridemia |
Feb, 2030
(4 years from now) | Active |
| US8546372 | Methods of treating hypertriglyceridemia |
Feb, 2030
(4 years from now) | Active |
| US8357677 | Methods of treating hypertriglyceridemia |
Feb, 2030
(4 years from now) | Active |
| US8293727 | Methods of treating hypertriglyceridemia |
Feb, 2030
(4 years from now) | Active |
| US12171738 | Compositions and methods for lowering triglycerides |
Feb, 2030
(4 years from now) | Active |
| US9198892 | Composition and/or method for preventing onset and/or recurrence of cardiovascular events |
Sep, 2027
(2 years from now) | Active |
| US9700537 | Composition for preventing the occurrence of cardiovascular event in multiple risk patient |
May, 2027
(2 years from now) | Active |
| US8188146 | Highly purified ethyl EPA and other EPA derivatives |
Jan, 2020
(5 years ago) |
Expired
|
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 Vascepa's patents.
Latest Legal Activities on Vascepa's Patents
Given below is the list of recent legal activities going on the following patents of Vascepa.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| 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 |
While patent expiration is one way of estimating the generic date of a drug, if a patent gets invalidated somehow, the generic of the drug may arrive early. Being aware of all relevant patents can help in avoiding legal pitfalls. Given below are details of the litigation history of Vascepa and ongoing litigations to help you estimate the early arrival of Vascepa generic.
Vascepa's Litigations
Vascepa been subject to various legal proceedings, including patent litigations. The earliest legal proceeding was initiated on Nov 30, 2021, against patent number US8642077. The petitioner Hikma Pharmaceuticals USA Inc. et al., challenged the validity of this patent, with Amarin Pharmaceuticals Ireland Limited as the respondent. Click below to track the latest information on how companies are challenging Vascepa's patents.
| Patent | Proceeding Filing Date | Status | Respondent | Petitioner |
|---|---|---|---|---|
 | ||||
| US8642077 | November, 2021 |
Terminated-Settled
(14 Mar, 2022) | Amarin Pharmaceuticals Ireland Limited | Hikma Pharmaceuticals USA Inc. et al. |
FDA has granted some exclusivities to Vascepa. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Vascepa, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Vascepa.
Exclusivity Information
Vascepa holds 3 exclusivities. All of its exclusivities have expired in 2022. Details of Vascepa's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Product(NP) | Jul 26, 2015 |
| New Chemical Entity Exclusivity(NCE) | Jul 26, 2017 |
| New Indication(I-819) | Dec 13, 2022 |
Several oppositions have been filed on Vascepa's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Vascepa's generic, the next section provides detailed information on ongoing and past EP oppositions related to Vascepa patents.
Vascepa's Oppositions Filed in EPO
Vascepa has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Feb 27, 2014, by Vogelsang-Wenke, Heike. This opposition was filed on patent number EP10704464A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
| | |||
| EP17187534A | Dec, 2021 | Cooke, Richard | Revoked |
| EP17187534A | Dec, 2021 | Hoffman Eitle Patent- und Rechtsanwälte Partnerschaftsgesellschaft mbB | Revoked |
| EP17187534A | Nov, 2021 | ELKINGTON AND FIFE LLP | Revoked |
| EP17206714A | Sep, 2021 | Hoffmann Eitle | Granted and Under Opposition |
| EP17206714A | Sep, 2021 | Cooke, Richard | Granted and Under Opposition |
| EP17206714A | Sep, 2021 | ELKINGTON AND FIFE LLP | Granted and Under Opposition |
| EP17168056A | Jun, 2021 | ELKINGTON AND FIFE LLP | Revoked |
| EP13156122A | Aug, 2020 | Hoffmann Eitle | Revoked |
| EP16152447A | Aug, 2020 | Hoffmann Eitle | Revoked |
| EP16152447A | Aug, 2020 | ELKINGTON AND FIFE LLP | Revoked |
| EP13156122A | Aug, 2020 | ELKINGTON AND FIFE LLP | Revoked |
| EP10704464A | Feb, 2014 | Sandoz AG | Revoked |
| EP10704464A | Feb, 2014 | Vogelsang-Wenke, Heike | Revoked |
US patents provide insights into the exclusivity only within the United States, but Vascepa is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Vascepa's family patents as well as insights into ongoing legal events on those patents.
Vascepa's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Vascepa's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Jun 28, 2033 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Vascepa Generic API suppliers:
Icosapent Ethyl is the generic name for the brand Vascepa. 10 different companies have already filed for the generic of Vascepa, with Strides Softgels having the maximum number of approved applications. Check out the entire list of companies who have already received approval for Vascepa's generic
How can I launch a generic of Vascepa before its drug patent expiration? :
You can seek FDA approval to launch a generic drug before the expiration of Vascepa's patents related by providing a 'paragraph IV certification' in your application, which states that the patent submitted by the Vascepa's sponsor is invalid, unenforceable, or will not be infringed by your generic product.
Given below are the details of the already filed Para IV certificates on Vascepa -
| Strength | Submission Date | ANDA(s) Filed | First applicant approval | Last patent expiry | 180 day status |
|---|---|---|---|---|---|
| 1 g | 26 Jul, 2016 | 4 | 21 May, 2020 | 29 Apr, 2030 | Deferred |
| 500 mg | 29 Aug, 2017 | 1 | 11 Sep, 2020 | 29 Apr, 2030 | Non-Forfeiture |
About Vascepa
Vascepa is a drug owned by Amarin Pharmaceuticals Ireland Ltd. It is used for reducing the risk of cardiovascular events in adult patients with elevated triglyceride levels as an adjunct to statin therapy. Vascepa uses Icosapent Ethyl as an active ingredient. Vascepa was launched by Amarin Pharms in 2012.
Approval Date:
Vascepa was approved by FDA for market use on 26 July, 2012.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Vascepa is 26 July, 2012, its NCE-1 date is estimated to be 26 July, 2016.
Active Ingredient:
Vascepa uses Icosapent Ethyl as the active ingredient. Check out other Drugs and Companies using Icosapent Ethyl ingredient
Treatment:
Vascepa is used for reducing the risk of cardiovascular events in adult patients with elevated triglyceride levels as an adjunct to statin therapy.
Dosage:
Vascepa is available in capsule form for oral use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 500MG | CAPSULE | Prescription | ORAL |
| 1GM | CAPSULE | Prescription | ORAL |