OMEGA-3-ACID ETHYL ESTERS - Generic Drug Details

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

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Strides Pharma	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	203893-001	Sep 19, 2017	AB	RX	No	No
Sun Pharm	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	210834-001	Jan 9, 2020	AB	RX	No	No
Glw	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	091028-001	Apr 7, 2014	AB	RX	No	No
Osmotica Pharm Us	OMTRYG	omega-3-acid ethyl esters type a	CAPSULE;ORAL	204977-001	Apr 23, 2014		DISCN	Yes	No
Woodward	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004	AB	RX	Yes	Yes
Wilshire Pharms Inc	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	211345-001	Dec 7, 2023	AB	RX	No	No
Sofgen Pharms	OMEGA-3-ACID ETHYL ESTERS	omega-3-acid ethyl esters	CAPSULE;ORAL	211355-001	Jul 10, 2019	AB	RX	No	No

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
Woodward	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004
Woodward	LOVAZA	omega-3-acid ethyl esters	CAPSULE;ORAL	021654-001	Nov 10, 2004