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Last Updated: March 19, 2024

EPANOVA Drug Patent Profile


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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

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Summary for EPANOVA
Drug patent expirations by year for EPANOVA
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for EPANOVA
Generic Entry Date for EPANOVA*:
Constraining patent/regulatory exclusivity:
NDA:
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

SponsorPhase
Quintiles, Inc.Phase 3
IQVIA RDS Inc.Phase 3
The Cleveland ClinicPhase 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 ⤷  Try a Trial.

This potential generic entry date is based on patent ⤷  Try a Trial.

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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
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: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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

DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial
Patented Use: TREATMENT OF HYPERTRIGLYCERIDEMIA

DPA-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  Try a Trial

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

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 ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Astrazeneca EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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

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 ⤷  Try a Trial ⤷  Try a Trial
Astrazeneca EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 ⤷  Try a Trial ⤷  Try a Trial
>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.

Country Patent Number Title Estimated Expiration
South Africa 201405765 DPA-ENRICHED COMPOSITIONS OF OMEGA-3 POLYUNSATURATED FATTY ACIDS IN FREE ACID FORM ⤷  Try a Trial
Slovakia 152397 TREATMENT OF INFLAMMATORY BOWEL DISEASE USING ORAL DOSAGE FORMS OF OMEGA-3 POLYUNSATURATED ACIDS ⤷  Try a Trial
South Africa 9603854 ⤷  Try a Trial
Lithuania 2800563 ⤷  Try a Trial
South Korea 100427112 ⤷  Try a Trial
Israel 266231 תרכובות של חומצות שומן רב-בלתי רוויות של אומגה-3 מועשרות ב- dpa בצורת שומן בפאזה חומצית חופשית (Dpa-enriched compositions of omega-3 polyunsaturated fatty acids in free acid form) ⤷  Try a Trial
Japan 2007522192 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.