EPANOVA Drug Patent Profile

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:	316
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
IQVIA RDS Inc.	Phase 3
The Cleveland Clinic	Phase 3
Cleveland Clinic Coordinating Center for Clinical Research (C5R)	Phase 3

See all EPANOVA clinical trials

US Patents and Regulatory Information for EPANOVA

EPANOVA is protected by seven US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Patents protecting 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

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

When does loss-of-exclusivity occur for EPANOVA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Austria

Brazil

Canada

China

Cyprus

Denmark

European Patent Office

Germany

Israel

Japan

Mexico

Norway

Poland

Portugal

Slovenia

South Africa

South Korea

Spain

United Kingdom

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering EPANOVA around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	2800563	COMPOSITIONS ENRICHIES EN DPA D'ACIDES GRAS OMÉGA-3 POLYINSATURÉS SOUS FORME D'ACIDE LIBRE (DPA-ENRICHED COMPOSITIONS OF OMEGA-3 POLYUNSATURATED FATTY ACIDS IN FREE ACID FORM)
World Intellectual Property Organization (WIPO)	9636329
Japan	2012149073	PHARMACEUTICAL COMPOSITION
Peru	20142459	COMPOSICIONES ENRIQUECIDAS CON DPA DE ACIDOS GRASOS OMEGA 3 POLIINSATURADOS EN FORMA DE ACIDO LIBRE
Hong Kong	1251457	製備游離酸形式的ω-3多不飽和脂肪酸富含DPA的組合物的方法 (METHODS FOR MAKING DPA-ENRICHED COMPOSITIONS OF OMEGA-3 POLYUNSATURATED FATTY ACIDS IN FREE ACID FORM)