Omega-3-acid ethyl esters - Generic Drug Details
✉ Email this page to a colleague
What are the generic drug 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, Sofgen Pharms, Strides Pharma, Sun Pharm, Wilshire Pharms Inc, 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-two 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: | 22 |
Raw Ingredient (Bulk) Api Vendors: | 4 |
Clinical Trials: | 73 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Puracap Pharm Llc | OMEGA-3-ACID ETHYL ESTERS | omega-3-acid ethyl esters | CAPSULE;ORAL | 210093-001 | Jun 15, 2020 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Mankind Pharma | OMEGA-3-ACID ETHYL ESTERS | omega-3-acid ethyl esters | CAPSULE;ORAL | 215458-001 | Nov 15, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cspc-nbp Pharm | OMEGA-3-ACID ETHYL ESTERS | omega-3-acid ethyl esters | CAPSULE;ORAL | 211979-001 | May 12, 2020 | 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 |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.