ICOSAPENT ETHYL - Generic Drug Details
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What are the generic drug sources for icosapent ethyl and what is the scope of patent protection?
Icosapent ethyl
is the generic ingredient in two branded drugs marketed by Apotex, Dr Reddys, Hikma, Teva Pharms Usa, and Amarin Pharms, and is included in five NDAs. There are sixty-nine patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.Icosapent ethyl has three hundred and thirty-two patent family members in forty-four countries.
There are six drug master file entries for icosapent ethyl. Seven suppliers are listed for this compound.
Summary for ICOSAPENT ETHYL
| International Patents: | 332 |
| US Patents: | 69 |
| Tradenames: | 2 |
| Applicants: | 5 |
| NDAs: | 5 |
| Drug Master File Entries: | 6 |
| Finished Product Suppliers / Packagers: | 7 |
| Raw Ingredient (Bulk) Api Vendors: | 57 |
| Clinical Trials: | 17 |
| Patent Applications: | 4,092 |
| Drug Prices: | Drug price trends for ICOSAPENT ETHYL |
| Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for ICOSAPENT ETHYL |
| What excipients (inactive ingredients) are in ICOSAPENT ETHYL? | ICOSAPENT ETHYL excipients list |
| DailyMed Link: | ICOSAPENT ETHYL at DailyMed |
Recent Clinical Trials for ICOSAPENT ETHYL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 1/Phase 2 |
| HLS Therapeutics, Inc | Phase 4 |
| Unity Health Toronto | Phase 4 |
Paragraph IV (Patent) Challenges for ICOSAPENT ETHYL
| Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
|---|---|---|---|---|---|---|
| VASCEPA | Capsules | icosapent ethyl | 500 mg | 202057 | 1 | 2017-08-29 |
| VASCEPA | Capsules | icosapent ethyl | 1 g | 202057 | 4 | 2016-07-26 |
US Patents and Regulatory Information for ICOSAPENT ETHYL
| 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 | 202057-001 | Jul 26, 2012 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | AB | RX | Yes | Yes | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | Y | See Plans and Pricing | ||
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | AB | RX | Yes | No | See Plans and Pricing | See Plans and Pricing | See Plans and Pricing | |||
| >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 ICOSAPENT ETHYL
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-001 | Jul 26, 2012 | See Plans and Pricing | See Plans and Pricing |
| Amarin Pharms | VASCEPA | icosapent ethyl | CAPSULE;ORAL | 202057-002 | Feb 16, 2017 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
EU/EMA Drug Approvals for ICOSAPENT ETHYL
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| Amarin Pharmaceuticals Ireland Limited | Vazkepa | icosapent ethyl | EMEA/H/C/005398 Indicated to reduce cardiovascular risk as an adjunct to statin therapy. |
Authorised | no | no | no | 2021-03-26 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for ICOSAPENT ETHYL
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Norway | 2424356 | See Plans and Pricing | |
| New Zealand | 597193 | Compositions and methods for lowering triglycerides without raising ldl-c levels in a subject on concomitant statin therapy | See Plans and Pricing |
| Eurasian Patent Organization | 201500069 | СПОСОБЫ УМЕНЬШЕНИЯ РИСКА РАЗВИТИЯ СЕРДЕЧНО-СОСУДИСТОГО СОБЫТИЯ У СУБЪЕКТА, ПОЛУЧАЮЩЕГО ТЕРАПИЮ СТАТИНОМ | See Plans and Pricing |
| Russian Federation | 2686315 | СПОСОБЫ ЛЕЧЕНИЯ ГИПЕРТРИГЛИЦЕРИДЕМИИ (METHODS OF TREATMENT OF HYPERTRIGLYCERIDEMIA) | See Plans and Pricing |
| Singapore | 10201610916S | USE OF EICOSAPENTAENOIC ACID ETHYL ESTER FOR TREATING HYPERTRIGLYCERIDEMIA | See Plans and Pricing |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for ICOSAPENT ETHYL
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2443246 | CA 2021 00036 | Denmark | See Plans and Pricing | PRODUCT NAME: ICOSAPENT ETHYL; REG. NO/DATE: EU/1/20/1524 20210329 |
| 2443246 | 301137 | Netherlands | See Plans and Pricing | PRODUCT NAME: ICOSAPENT-ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210329 |
| 2443246 | 39/2021 | Austria | See Plans and Pricing | PRODUCT NAME: ICOSAPENT-ETHYL (= EICOSAPENTAENSAEUREETHYLESTER,; REGISTRATION NO/DATE: EU/1/20/1524 20210329 |
| 2022495 | 122021000058 | Germany | See Plans and Pricing | PRODUCT NAME: ICOSAPENT-ETHYL; REGISTRATION NO/DATE: EU/1/20/1524 20210326 |
| 2443246 | 21C1046 | France | See Plans and Pricing | PRODUCT NAME: ICOSAPENT ETHYL; NAT. REGISTRATION NO/DATE: EU/1/20/1524 20210329; FIRST REGISTRATION: - EU/1/20/1524 20210329 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
