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Serving leading biopharmaceutical companies globally:

Teva
Federal Trade Commission
Cipla
Deloitte
Merck
Daiichi Sankyo
Harvard Business School
Chubb
Argus Health
QuintilesIMS

Generated: February 22, 2018

DrugPatentWatch Database Preview

FENOFIBRATE - Generic Drug Details

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What are the generic sources for fenofibrate and what is the scope of fenofibrate freedom to operate?

Fenofibrate
is the generic ingredient in nine branded drugs marketed by Lupin Atlantis, Sun Pharm Inds Ltd, Apotex Inc, Cnty Line Pharms, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Mylan Pharms Inc, Rhodes Pharms, Abbvie, Cipher Pharms Inc, Amneal Pharms Llc, Aurobindo Pharma Ltd, Cipla Ltd, Hetero Labs Ltd Iii, Lupin Ltd, Mylan, Valeant Pharms North, Santarus Inc, Abbvie Inc, and Skyepharma Ag, and is included in thirty-two NDAs. There are eighteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fenofibrate has four hundred and seventeen patent family members in forty-nine countries.

There are forty-two drug master file entries for fenofibrate. Fifty-seven suppliers are listed for this compound. There is one tentative approval for this compound.
Summary for FENOFIBRATE
Medical Subject Heading (MeSH) Categories for FENOFIBRATE
Tentative approvals for FENOFIBRATE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial43MGCAPSULE; ORAL
➤ Try a Free Trial➤ Try a Free Trial130MGCAPSULE; ORAL

US Patents and Regulatory Information for FENOFIBRATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms Inc FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 202579-001 Jan 10, 2013 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Cipher Pharms Inc LIPOFEN fenofibrate CAPSULE;ORAL 021612-002 Jan 11, 2006 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Valeant Pharms North FENOFIBRATE fenofibrate TABLET;ORAL 090715-001 Apr 5, 2012 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Hetero Labs Ltd Iii FENOFIBRATE fenofibrate TABLET;ORAL 204598-002 Jul 12, 2016 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie Inc TRICOR fenofibrate TABLET;ORAL 021203-003 Sep 4, 2001 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Lupin Ltd FENOFIBRATE fenofibrate TABLET;ORAL 090856-002 Dec 23, 2011 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan FENOFIBRATE fenofibrate TABLET;ORAL 076520-003 Oct 25, 2007 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Abbvie Inc TRICOR fenofibrate TABLET;ORAL 021203-003 Sep 4, 2001 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial Y ➤ Try a Free Trial
Abbvie Inc TRICOR fenofibrate TABLET;ORAL 021203-001 Sep 4, 2001 DISCN Yes No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan Pharms Inc FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 202676-002 Oct 23, 2012 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for FENOFIBRATE

Non-Orange Book US Patents for FENOFIBRATE

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
8,529,952 Pharmaceutical composition containing fenofibrate and method for the preparation thereof ➤ Try a Free Trial
7,695,739 In vitro methods for evaluating the in vivo effectiveness of dosage forms of microparticulate or nanoparticulate active agent compositions ➤ Try a Free Trial
6,534,088 Fibrate-statin combinations with reduced fed-fasted effects ➤ Try a Free Trial
7,288,267 Bioadhesive nanoparticulate compositions having cationic surface stabilizers ➤ Try a Free Trial
7,772,273 Stabilized atorvastatin ➤ Try a Free Trial
6,811,767 Liquid droplet aerosols of nanoparticulate drugs ➤ Try a Free Trial
6,592,903 Nanoparticulate dispersions comprising a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate ➤ Try a Free Trial
8,309,136 In vitro methods for evaluating the in vivo effectiveness of dosage forms of microparticulate or nanoparticulate active agent compositions ➤ Try a Free Trial
8,124,057 Propellant-based nanoparticulate dry powder aerosols and method of making ➤ Try a Free Trial
7,850,995 Bioadhesive nanoparticulate compositions having cationic surface stabilizers ➤ Try a Free Trial
Patent No. Title Estimated Patent Expiration

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International Patents for FENOFIBRATE

For more information try a trial or see the plans and pricing

Serving hundreds of leading biopharmaceutical companies globally:

Fish and Richardson
Harvard Business School
Merck
Baxter
Julphar
Daiichi Sankyo
Argus Health
Teva
Moodys

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 verifification 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.

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