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VASCEPA Drug Profile
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» See Plans and PricingWhen 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 fifty-one patents protecting this drug and three Paragraph IV challenges.
This drug has two hundred and fifty patent family members in forty-nine countries.
The generic ingredient in VASCEPA is icosapent ethyl. There are twelve drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the icosapent ethyl profile page.
US ANDA Litigation and Generic Entry Outlook for Vascepa
Vascepa was eligible for patent challenges on July 26, 2016.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be December 13, 2022. This may change due to patent challenges or generic licensing.
There have been nine patent litigation cases involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.
Indicators of Generic Entry
Summary for VASCEPA
| International Patents: | 250 |
| US Patents: | 51 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 32 |
| Clinical Trials: | 10 |
| Patent Applications: | 213 |
| Drug Prices: | Drug price information for VASCEPA |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for VASCEPA |
| DailyMed Link: | VASCEPA at DailyMed |
Generic Entry Opportunity Date for VASCEPA
Generic Entry Date for VASCEPA*:
Constraining patent/regulatory exclusivity:
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 NDA:
Dosage:
CAPSULE;ORAL |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
Recent Clinical Trials for VASCEPA
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Matinas Biopharma, Inc | Phase 2 |
| MB Clinical Research and Consulting LLC | Phase 2 |
| Matinas BioPharma Nanotechnologies, Inc. | Phase 2 |
Recent Litigation for VASCEPA
Identify potential future generic entrants
District Court Litigation
| Case Name | Date |
|---|---|
| Amarin Pharma, Inc. v. Dr. Reddy's Laboratories, Inc. | 2018-08-24 |
| Amarin Pharma Inc. v. Hikma Pharmaceuticals USA Inc. | 2016-10-31 |
| Amarin Pharma Inc. v. West-Ward Pharmaceuticals Corp | 2016-10-31 |
Synonyms for VASCEPA
| (5Z,8Z,11Z,14Z,17Z)-Eicosapentaenoic acid ethyl ester |
| (5Z,8Z,11Z,14Z,17Z)-Eicosapetaenoic acid ethyl ester |
| (all-Z)-5,8,11,14,17-Eicosapentaenoic acid ethyl ester |
| 1606AH |
| 5-8-11-14-17-all cis-eicosapentaenoic acid ethyl ester |
| 5,8,11,14,17-Eicosapentaenoic acid, ethyl ester, (all-Z)- |
| 5Z,8Z,11Z,14Z,17Z-Eicosapentaenoic acid, ethyl ester |
| 6GC8A4PAYH |
| 86227-47-6 |
| AB01563352_01 |
| AKOS025295847 |
| all cis-5,8,11,14,17-Eicosapentaenoic Acid Ethyl Ester |
| all-cis-ethyl 5,8,11,14,17-icosapentaenoate |
| AMR 101 |
| AMR-101 |
| AMR101 |
| C16184 |
| C22H34O2 |
| CCG-213714 |
| CHEBI:80366 |
| CHEBI:84883 |
| CHEMBL2095209 |
| cis-Eicosapentaenoic acid ethyl ester |
| CS-5304 |
| D01892 |
| DB08887 |
| E-EPA |
| E0442 |
| E0853 |
| Eicosapentaenoic acid (ethyl ester) |
| Eicosapentaenoic acid ethyl ester |
| Eicosapentaenoic acid, ethyl ester |
| EICOSAPENTAENOICACIDETHYLESTER(EPAEE)(SG) |
| EPA ethyl ester |
| EPA-E |
| Epadel |
| Epadel S (TN) |
| Ethyl (5Z,8Z,11Z,14Z,17Z)-eicosa-5,8,11,14,17-pentaenoate |
| ethyl (5Z,8Z,11Z,14Z,17Z)-eicosapentaenoate |
| ethyl (5Z,8Z,11Z,14Z,17Z)-icosa-5,8,11,14,17-pentaenoate |
| ethyl (5Z,8Z,11Z,14Z,17Z)-icosapentaenoate |
| Ethyl (all cis)-5,8,11,14,17-icosapentaenoate |
| Ethyl all cis-5,8,11,14,17-Eicosapentaenoate |
| Ethyl all cis-5,8,11,14,17-Icosapentaenoate |
| ethyl all-cis-5,8,11,14,17-icosapentaenoate |
| Ethyl all-cis-5,8,11,14,17-icosapentaenoic acid |
| ethyl eicosapentaenoate |
| Ethyl eicosapentaenoic acid |
| Ethyl EPA |
| Ethyl ester(all-Z)-5,8,11,14,17-Eicosapentaenoic acid |
| ethyl icosapentaenoate |
| ethyl icosapentate |
| Ethyl icosapentate (JP17) |
| Ethyl icosapentate [JAN] |
| Ethyl icosapentate, JAN |
| ethyl-eicosapentaenoic acid |
| ethyl-EPA |
| GTPL7441 |
| HMS2094K19 |
| HY-B0747 |
| ICOSAPENT ETHYL |
| Icosapent ethyl (USAN) |
| Icosapent ethyl [USAN] |
| icosapentate |
| LMFA07010877 |
| LS-63776 |
| MND 21 |
| NSC-759597 |
| NSC759597 |
| OMEGA-3-ACID ESTERS (EPA shown) |
| Pharmakon1600-01300030 |
| Q5404453 |
| SBI-0206684.P002 |
| SCHEMBL123305 |
| SR-05000002595 |
| SR-05000002595-1 |
| SSQPWTVBQMWLSZ-AAQCHOMXSA-N |
| Timnodonic acid ethyl ester |
| UNII-6GC8A4PAYH |
| UNII-D87YGH4Z0Q component SSQPWTVBQMWLSZ-AAQCHOMXSA-N |
| Vascepa (TN) |
| WE(22:5) |
| ZINC3785276 |
Paragraph IV (Patent) Challenges for VASCEPA
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| VASCEPA | CAPSULE;ORAL | icosapent ethyl | 202057 | 2017-08-29 |
| VASCEPA | CAPSULE;ORAL | icosapent ethyl | 202057 | 2016-07-26 |
US Patents and Regulatory Information for VASCEPA
| 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 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | RX | Yes | No | Start Trial | Start Trial | Start Trial | ||||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | RX | Yes | No | Start Trial | Start Trial | Start 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 | 202057-001 | Jul 26, 2012 | Start Trial | Start Trial |
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for VASCEPA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| New Zealand | 627238 | Start Trial |
| Australia | 2010241567 | Start Trial |
| European Patent Office | 2443246 | Start Trial |
| Australia | 2013282394 | Start Trial |
| Denmark | 2395991 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
Supplementary Protection Certificates for VASCEPA
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 0253738 | 96C0009 | Belgium | Start 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: |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
