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Last Updated: November 25, 2020

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EPANOVA Drug Profile

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US ANDA Litigation and 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
International Patents:113
US Patents:9
Applicants:1
NDAs:1
Bulk Api Vendors: 1
Clinical Trials: 16
Patent Applications: 1
Formulation / Manufacturing:see details
DailyMed Link:EPANOVA at DailyMed
Drug patent expirations by year for EPANOVA
Generic Entry Opportunity 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
Cleveland Clinic Coordinating Center for Clinical Research (C5R)Phase 3
Quintiles, Inc.Phase 3
Omthera Pharmaceuticals, IncPhase 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 Pharms EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Astrazeneca Pharms EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Astrazeneca Pharms EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 DISCN Yes No   Start Trial   Start Trial   Start Trial
Astrazeneca Pharms EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 DISCN Yes No   Start Trial   Start Trial Y   Start Trial
Astrazeneca Pharms EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014 DISCN Yes No   Start Trial   Start Trial Y   Start 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 Pharms EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014   Start Trial   Start Trial
Astrazeneca Pharms EPANOVA omega-3-carboxylic acids CAPSULE;ORAL 205060-001 May 5, 2014   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

Express Scripts
McKinsey
Boehringer Ingelheim
AstraZeneca
Baxter
Colorcon

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.