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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
Healthtrust
QuintilesIMS
Cerilliant
Deloitte
Johnson and Johnson
Teva
UBS
McKinsey
AstraZeneca

Generated: October 18, 2017

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Fenofibrate - Generic Drug Details

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

Fenofibrate
is the generic ingredient in nine branded drugs marketed by Abbvie Inc, Abbvie, Cipla Ltd, Impax Labs, Cipher Pharms Inc, Valeant Pharms North, Aurobindo Pharma Ltd, Santarus Inc, Lupin Ltd, Mylan, Rhodes Pharms, Sun Pharm Inds Ltd, Skyepharma Ag, Apotex Inc, Mylan Pharms Inc, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Invagen Pharms, Lupin Atlantis, and Hetero Labs Ltd Iii, and is included in twenty-nine 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 fourteen patent family members in forty-nine countries.

There are forty-two drug master file entries for fenofibrate. Fifty-four suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: fenofibrate

US Patents:18
Tradenames:9
Applicants:20
NDAs:29
Drug Master File Entries: see list42
Suppliers / Packagers: see list54
Bulk Api Vendors: see list80
Clinical Trials: see list138
Patent Applications: see list5,802
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fenofibrate at DailyMed

Pharmacology for Ingredient: fenofibrate

Tentative approvals for FENOFIBRATE

Applicant Application No. Strength Dosage Form
u► Subscribe43MGCAPSULE; ORAL
u► Subscribe130MGCAPSULE; ORAL
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
fenofibrate
TABLET;ORAL202856-001Dec 7, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Mylan
FENOFIBRATE
fenofibrate
TABLET;ORAL076520-001Oct 25, 2007ABRXNoNo► Subscribe► Subscribe► Subscribe
Abbvie
TRICOR
fenofibrate
TABLET;ORAL021656-001Nov 5, 2004ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Abbvie Inc
TRICOR
fenofibrate
TABLET;ORAL021203-003Sep 4, 2001DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Abbvie Inc
TRICOR
fenofibrate
TABLET;ORAL021203-003Sep 4, 2001DISCNYesNo► Subscribe► SubscribeY ► Subscribe
Mylan Pharms Inc
FENOFIBRATE (MICRONIZED)
fenofibrate
CAPSULE;ORAL202579-001Jan 10, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Abbvie
TRICOR
fenofibrate
TABLET;ORAL021656-002Nov 5, 2004ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Abbvie
TRICOR
fenofibrate
TABLET;ORAL021656-002Nov 5, 2004ABRXYesYes► Subscribe► SubscribeY ► Subscribe
Apotex Inc
FENOFIBRATE (MICRONIZED)
fenofibrate
CAPSULE;ORAL202252-001Jul 26, 2013ABRXNoNo► Subscribe► Subscribe► Subscribe
Santarus Inc
FENOGLIDE
fenofibrate
TABLET;ORAL022118-002Aug 10, 2007ABRXYesYes► Subscribe► SubscribeY ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fenofibrate

Non-Orange Book Patents for Generic Ingredient: 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
7,459,283Nanoparticulate compositions having lysozyme as a surface stabilizer► Subscribe
7,198,795In vitro methods for evaluating the in vivo effectiveness of dosage forms of microparticulate of nanoparticulate active agent compositions► Subscribe
7,521,068Dry powder aerosols of nanoparticulate drugs► Subscribe
8,124,057Propellant-based nanoparticulate dry powder aerosols and method of making► Subscribe
6,596,317 Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it► Subscribe
8,652,464Method of treatment using nanoparticulate compositions having lysozyme as a surface stabilizer► Subscribe
6,316,029 Rapidly disintegrating solid oral dosage form► Subscribe
8,658,212Pharmaceutical composition containing fenofibrate and method for the preparation thereof► Subscribe
7,931,917Nanoparticulate fibrate formulations► Subscribe
8,293,277Controlled-release nanoparticulate compositions► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Ingredient: fenofibrate

Country Document Number Estimated Expiration
Japan2010018604► Subscribe
TaiwanI354568► Subscribe
World Intellectual Property Organization (WIPO)0126635► Subscribe
European Patent Office1273294► Subscribe
European Patent Office1282399► Subscribe
European Patent Office1320362► Subscribe
Germany602004020641► Subscribe
Hungary227758► Subscribe
South Korea20110116252► Subscribe
Argentina040110► Subscribe
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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

Serving leading biopharmaceutical companies globally:

Cerilliant
Argus Health
Daiichi Sankyo
Federal Trade Commission
Fish and Richardson
McKesson
Fuji
Cipla
Merck
Covington

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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