ICOSAPENT ETHYL Drug Patent Profile
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Which patents cover Icosapent Ethyl, and what generic alternatives are available?
Icosapent Ethyl is a drug marketed by Apotex, Ascent Pharms Inc, Dr Reddys, Hikma, Humanwell Puracap, Strides Pharma, Teva Pharms Usa, and Zydus. and is included in eight NDAs.
The generic ingredient in ICOSAPENT ETHYL is icosapent ethyl. There are twelve drug master file entries for this compound. Fifteen suppliers are listed for this compound. Additional details are available on the icosapent ethyl profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Icosapent Ethyl
A generic version of ICOSAPENT ETHYL was approved as icosapent ethyl by HIKMA on May 21st, 2020.
Summary for ICOSAPENT ETHYL
Recent Clinical Trials for ICOSAPENT ETHYL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| National Cancer Institute (NCI) | Phase 1/Phase 2 |
| Unity Health Toronto | Phase 4 |
| Canadian Medical and Surgical Knowledge Translation Research Group | 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 |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Apotex | ICOSAPENT ETHYL | icosapent ethyl | CAPSULE;ORAL | 209437-001 | Jun 30, 2021 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Hikma | ICOSAPENT ETHYL | icosapent ethyl | CAPSULE;ORAL | 209457-002 | Mar 8, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Dr Reddys | ICOSAPENT ETHYL | icosapent ethyl | CAPSULE;ORAL | 209499-001 | Aug 7, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Teva Pharms Usa | ICOSAPENT ETHYL | icosapent ethyl | CAPSULE;ORAL | 209525-002 | Sep 11, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| Humanwell Puracap | ICOSAPENT ETHYL | icosapent ethyl | CAPSULE;ORAL | 217919-002 | Dec 22, 2023 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity 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 |
