DrugPatentWatch Database Preview
VASCEPA Drug Profile
Which patents cover Vascepa, and what generic alternatives are available?
Vascepa is a drug marketed by Amarin Pharms and is included in one NDA. There are twenty-five patents protecting this drug and three Paragraph IV challenges.
This drug has one hundred and thirty-three patent family members in forty-one 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.
Summary for VASCEPA
| International Patents: | 133 |
| US Patents: | 25 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 30 |
| Clinical Trials: | 7 |
| 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:
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 |
|---|---|
| Mingyang Song | Phase 2 |
| Harvard School of Public Health | Phase 2 |
| University of Leeds | Phase 3 |
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. West-Ward Pharmaceuticals Corp | 2016-10-31 |
| AMARIN PHARMA, INC. v. DR. REDDY'S LABORATORIES, INC. | 2014-04-30 |
Synonyms for VASCEPA
| (5Z,8Z,11Z,14Z,17Z)-5,8,11,14,17-Eicosapentaenoic Acid Ethyl Ester |
| (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 |
| AN-5630 |
| C16184 |
| C22H34O2 |
| CCG-213714 |
| CHEBI:80366 |
| CHEBI:84883 |
| CHEMBL2095209 |
| cis-5,8,11,14,17-Eicosapentaenoic acid ethyl ester |
| 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 |
| MolPort-006-393-913 |
| NSC-759597 |
| NSC759597 |
| OMEGA-3-ACID ESTERS (EPA shown) |
| Pharmakon1600-01300030 |
| 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 | 202057-002 | 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 | ||||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
International Patents for VASCEPA
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Cyprus | 1114276 | Start Trial |
| Poland | 199778 | Start Trial |
| South Korea | 20120089563 | Start Trial |
| Turkey | 200504156 | 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 |
