OMEGA-3-ACID ETHYL ESTERS Drug Patent Profile
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When do Omega-3-acid Ethyl Esters patents expire, and when can generic versions of Omega-3-acid Ethyl Esters launch?
Omega-3-acid Ethyl Esters is a drug marketed by Amneal Pharms, Apotex, Ascent Pharms Inc, Bionpharma, Cspc-nbp Pharm, GLW, Mankind Pharma, Puracap Pharm Llc, Slayback Pharma Llc, Sofgen Pharms, Strides Pharma, Sun Pharm, and Zydus. and is included in fifteen NDAs.
The generic ingredient in OMEGA-3-ACID ETHYL ESTERS is omega-3-acid ethyl esters. There are thirteen drug master file entries for this compound. Twenty-two suppliers are listed for this compound. Additional details are available on the omega-3-acid ethyl esters profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Omega-3-acid Ethyl Esters
A generic version of OMEGA-3-ACID ETHYL ESTERS was approved as omega-3-acid ethyl esters by GLW on April 7th, 2014.
Summary for OMEGA-3-ACID ETHYL ESTERS
Recent Clinical Trials for OMEGA-3-ACID ETHYL ESTERS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Sohag University | Phase 2/Phase 3 |
Jinnah Postgraduate Medical Centre | N/A |
Liaquat National Hospital & Medical College | N/A |
Pharmacology for OMEGA-3-ACID ETHYL ESTERS
Drug Class | Omega-3 Fatty Acid |
Paragraph IV (Patent) Challenges for OMEGA-3-ACID ETHYL ESTERS
Tradename | Dosage | Ingredient | Strength | NDA | ANDAs Submitted | Submissiondate |
---|---|---|---|---|---|---|
LOVAZA | Capsules | omega-3-acid ethyl esters | 1 g | 021654 | 3 | 2008-11-10 |
US Patents and Regulatory Information for OMEGA-3-ACID ETHYL ESTERS
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Amneal Pharms | OMEGA-3-ACID ETHYL ESTERS | omega-3-acid ethyl esters | CAPSULE;ORAL | 204940-001 | Nov 27, 2015 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Glw | OMEGA-3-ACID ETHYL ESTERS | omega-3-acid ethyl esters | CAPSULE;ORAL | 212504-001 | Aug 19, 2020 | AB | RX | No | No | ⤷ Try a Trial | ⤷ Try a Trial | ⤷ Try a Trial | |||
Bionpharma | OMEGA-3-ACID ETHYL ESTERS | omega-3-acid ethyl esters | CAPSULE;ORAL | 206455-001 | Aug 7, 2019 | 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 |