EPANOVA Drug Patent Profile

✉ Email this page to a colleague

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

< Available with Subscription >

Sign Up

AI Research Assistant

Questions you can ask:

What is the 5 year forecast for EPANOVA?
What are the global sales for EPANOVA?
What is Average Wholesale Price for EPANOVA?

Summary for EPANOVA

International Patents:	84
US Patents:	7
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	16
Patent Applications:	129
DailyMed Link:	EPANOVA at DailyMed

Drug patent expirations by year for EPANOVA

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for EPANOVA

Generic Entry Date for EPANOVA^: ⤷ Sign Up* Constraining patent/regulatory exclusivity: ⤷ Sign Up 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
The Cleveland Clinic	Phase 3
Cleveland Clinic Coordinating Center for Clinical Research (C5R)	Phase 3
Quintiles, Inc.	Phase 3

See all EPANOVA clinical trials

US Patents and Regulatory Information for EPANOVA

EPANOVA is protected by seven US patents.

Based on analysis by DrugPatentWatch, the earliest date for a generic version of EPANOVA is ⤷ Sign Up.

This potential generic entry date is based on patent ⤷ Sign Up.
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

DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF SEVERE HYPERTRIGLYCERIDEMIA (500 MG/DL) IN ADULT PATIENTS AS AN ADJUNCT TO DIET

Type A gelatin capsule containing PUFA in free acid form
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Type a gelatin capsule containing PUFA in free acid form
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERTRIGLYCERIDEMIA

Type A gelatin capsule containing PUFA in free acid form
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERTRIGLYCERIDEMIA

DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up

Type A gelatin capsule containing PUFA in free acid form
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: TREATMENT OF HYPERTRIGLYCERIDEMIA

+ Get email alerts for changes to this table

Glossary

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	No	⤷ Sign Up	⤷ Sign Up	Y			⤷ Sign Up
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014		DISCN	Yes	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 EPANOVA

Subscribe to access the full database, or Sign Up
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	⤷ Sign Up	⤷ Sign Up
Astrazeneca	EPANOVA	omega-3-carboxylic acids	CAPSULE;ORAL	205060-001	May 5, 2014	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

International Patents for EPANOVA

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

Subscribe to access the full database, or Sign Up
Country	Patent Number	Title	Estimated Expiration
Hungary	227282	TREATMENT OF INFLAMMATORY BOWEL DISEASE USING ORAL DOSAGE FORMS OF OMEGA-3 POLYUNSATURATED ACIDS	⤷ Sign Up
Israel	177462	כפסול ג'לטין רך המכיל חומצה שמנית אומגה-3-רב-לא-רוויה (Soft gelatin capsule comprising omega-3-polyunsaturated fatty acid)	⤷ Sign Up
Germany	69634693		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration