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VASCEPA Drug Profile
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 twenty-five patents protecting this drug and three Paragraph IV challenges.
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
| US Patents: | 25 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 29 |
| Clinical Trials: | 5 |
| Patent Applications: | 196 |
| 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
*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.
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, (5Z,8Z,11Z,14Z,17Z)-(9CI) |
| 5,8,11,14,17-Eicosapentaenoic acid, (all-Z)-(8CI) |
| 5,8,11,14,17-Eicosapentaenoic acid, ethyl ester, (all-Z)- |
| 5Z,8Z,11Z,14Z,17Z-Eicosapentaenoic acid, ethyl ester |
| 6GC8A4PAYH |
| 73310-10-8 |
| 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 |
| D0G2MW |
| D0LW5J |
| D0Q8BT |
| 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 (TN) |
| 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 eicosapent |
| ethyl eicosapentaenoate |
| Ethyl eicosapentaenoic acid |
| Ethyl EPA |
| Ethyl ester(all-Z)-5,8,11,14,17-Eicosapentaenoic acid |
| ethyl icosapentaenoate |
| ethyl icosapentate |
| ETHYL ICOSAPENTATE (Benazolin-Ethyl) |
| Ethyl icosapentate (JP17) |
| Ethyl icosapentate [JAN] |
| Ethyl icosapentate, JAN |
| ethyl-eicosapent |
| ethyl-eicosapentaenoic acid |
| ethyl-EPA |
| GTPL7441 |
| HMS2094K19 |
| HY-B0747 |
| ICOSAPENT ETHYL |
| Icosapent ethyl (USAN) |
| Icosapent ethyl [USAN] |
| icosapentate |
| LMFA07010877 |
| LS-63776 |
| MFCD00673476 |
| 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) |
| ZINC3785276 |
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 | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | ➤ Sign Up | ||||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | RX | Yes | No | ➤ Sign Up | ➤ Sign Up | Y | Y | ➤ Sign Up | ||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Paragraph IV (Patent) Challenges for VASCEPA
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Capsules | 500 mg | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Capsules | 1 g | ➤ Subscribe | ➤ Sign Up |
| ➤ Subscribe | Capsules | 1 g | ➤ Subscribe | ➤ Sign Up |
International Patents for VASCEPA
| Country | Document Number | Estimated Expiration |
|---|---|---|
| Singapore | 175390 | ➤ Sign Up |
| Hong Kong | 1165944 | ➤ Sign Up |
| South Korea | 20110110321 | ➤ Sign Up |
| Country | Document Number | Estimated Expiration |
Supplementary Protection Certificates for VASCEPA
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|
| C0009 | Belgium | ➤ Sign Up | 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: |
| Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
