DrugPatentWatch Database Preview

EPANOVA Drug Patent Profile

Email this page to a colleague

« Back to Dashboard

Which patents cover Epanova, and when can generic versions of Epanova launch?

Epanova is a drug marketed by Astrazeneca and is included in one NDA. There are seven patents protecting this drug.

This drug has eighty-four patent family members in forty countries.

The generic ingredient in EPANOVA is omega-3-carboxylic acids. There is one drug master file entry for this compound. Additional details are available on the omega-3-carboxylic acids profile page.

DrugPatentWatch^® Generic Entry Outlook for Epanova

Epanova was eligible for patent challenges on May 5, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be December 20, 2026. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for EPANOVA

International Patents:	84
US Patents:	7
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	16
Patent Applications:	1
Formulation / Manufacturing:	see details
DailyMed Link:	EPANOVA at DailyMed

DrugPatentWatch^® Estimated Generic Entry Opportunity Date for EPANOVA

NDA:

205060

Dosage:

CAPSULE;ORAL

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for EPANOVA

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Cleveland Clinic Coordinating Center for Clinical Research (C5R)	Phase 3
Quintiles, Inc.	Phase 3
Omthera Pharmaceuticals, Inc	Phase 3

See all EPANOVA clinical trials

US Patents and Regulatory Information for EPANOVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No			Y
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No			Y
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No			Y
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No			Y
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No				Y
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No

Expired US Patents for EPANOVA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014

International Patents for EPANOVA

Country	Patent Number	Estimated Expiration
India	6125DEN2014
Mexico	9708758
Mexico	PA06008352
Colombia	7061070
Philippines	12014501553
Spain	2240995
Austria	457720