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, 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

See drug prices for OMEGA-3-ACID ETHYL ESTERS

Drug Sales Revenue Trends for OMEGA-3-ACID ETHYL ESTERS

See drug sales revenues 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
National Cancer Institute (NCI)	Phase 2
National Center for Advancing Translational Sciences (NCATS)	Early Phase 1
The University of Texas Health Science Center at San Antonio	Early Phase 1

See all OMEGA-3-ACID ETHYL ESTERS clinical trials

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

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Glossary

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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
Glw	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	212504-001	Aug 19, 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

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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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