OMEGA-3-ACID ETHYL ESTERS - Generic Drug Details
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What are the generic sources for omega-3-acid ethyl esters and what is the scope of patent protection?
Omega-3-acid ethyl esters
is the generic ingredient in three branded drugs marketed by Woodward, Amneal Pharms, Apotex, Ascent Pharms Inc, Chartwell, Cspc-nbp Pharm, GLW, Mankind Pharma, Puracap Pharm Llc, Slayback Pharma Llc, Sofgen Pharms, Strides Pharma, Sun Pharm, Zydus Lifesciences, and Osmotica Pharm Us, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.There are eleven drug master file entries for omega-3-acid ethyl esters. Twenty-one suppliers are listed for this compound.
Summary for OMEGA-3-ACID ETHYL ESTERS
US Patents: | 0 |
Tradenames: | 3 |
Applicants: | 15 |
NDAs: | 17 |
Drug Master File Entries: | 11 |
Finished Product Suppliers / Packagers: | 21 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Clinical Trials: | 73 |
Formulation / Manufacturing: | see details |
Drug Prices: | Drug price trends for OMEGA-3-ACID ETHYL ESTERS |
Drug Sales Revenues: | Drug sales revenues for OMEGA-3-ACID ETHYL ESTERS |
What excipients (inactive ingredients) are in OMEGA-3-ACID ETHYL ESTERS? | OMEGA-3-ACID ETHYL ESTERS excipients list |
DailyMed Link: | OMEGA-3-ACID ETHYL ESTERS at DailyMed |
Recent Clinical Trials for OMEGA-3-ACID ETHYL ESTERS
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
National Cancer Institute (NCI) | Phase 2 |
The University of Texas Health Science Center at San Antonio | Early Phase 1 |
National Center for Advancing Translational Sciences (NCATS) | Early Phase 1 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sun Pharm | OMEGA-3-ACID ETHYL ESTERS | omega-3-acid ethyl esters | CAPSULE;ORAL | 210834-001 | Jan 9, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Chartwell | OMEGA-3-ACID ETHYL ESTERS | omega-3-acid ethyl esters | CAPSULE;ORAL | 206455-001 | Aug 7, 2019 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Amneal Pharms | OMEGA-3-ACID ETHYL ESTERS | omega-3-acid ethyl esters | CAPSULE;ORAL | 204940-001 | Nov 27, 2015 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
>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 OMEGA-3-ACID ETHYL ESTERS
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Woodward | LOVAZA | omega-3-acid ethyl esters | CAPSULE;ORAL | 021654-001 | Nov 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Woodward | LOVAZA | omega-3-acid ethyl esters | CAPSULE;ORAL | 021654-001 | Nov 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
Woodward | LOVAZA | omega-3-acid ethyl esters | CAPSULE;ORAL | 021654-001 | Nov 10, 2004 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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