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Serving 500+ biopharmaceutical companies globally:

Harvard Business School
Teva
Cantor Fitzgerald
Julphar
Merck
AstraZeneca
Dow
US Army
Novartis
Fish and Richardson

Generated: August 18, 2017

DrugPatentWatch Database Preview

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 Abbott, 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-eight 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 three hundred and eighty-eight patent family members in forty-nine countries.

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

Summary for Generic Name: fenofibrate

Tradenames:9
Patents:18
Applicants:20
NDAs:28
Drug Master File Entries: see list42
Suppliers / Packagers: see list53
Bulk Api Vendors: see list80
Clinical Trials: see list138
Patent Applications: see list6,493
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
► Subscribe► Subscribe43MGCAPSULE; ORAL
► Subscribe► 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 (MICRONIZED)
fenofibrate
CAPSULE;ORAL202676-001Oct 23, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Santarus Inc
FENOGLIDE
fenofibrate
TABLET;ORAL022118-001Aug 10, 2007ABRXYesNo► Subscribe► SubscribeY ► Subscribe
Mylan Pharms Inc
FENOFIBRATE
fenofibrate
TABLET;ORAL202856-001Dec 7, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-003Nov 30, 2004ABRXYesYes► Subscribe► SubscribeYY ► Subscribe
Abbott
TRICOR
fenofibrate
TABLET;ORAL021203-001Sep 4, 2001DISCNYesNo► Subscribe► Subscribe ► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fenofibrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-001Nov 30, 2004► Subscribe► Subscribe
Cipher Pharms Inc
LIPOFEN
fenofibrate
CAPSULE;ORAL021612-003Jan 11, 2006► Subscribe► Subscribe
Abbvie
TRICOR
fenofibrate
TABLET;ORAL021656-002Nov 5, 2004► Subscribe► Subscribe
Abbvie
TRICOR (MICRONIZED)
fenofibrate
CAPSULE;ORAL019304-003Jun 30, 1999► Subscribe► Subscribe
Abbott
TRICOR
fenofibrate
TABLET;ORAL021203-001Sep 4, 2001► Subscribe► Subscribe
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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
8,703,202Coated tablets► Subscribe
7,931,917Nanoparticulate fibrate formulations► Subscribe
7,198,795In vitro methods for evaluating the in vivo effectiveness of dosage forms of microparticulate of nanoparticulate active agent compositions► Subscribe
8,323,641Nanoparticulate compositions having lysozyme as a surface stabilizer► Subscribe
6,596,317 Fenofibrate pharmaceutical composition having high bioavailability and method for preparing it► 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
Japan2003511406► Subscribe
World Intellectual Property Organization (WIPO)2014091318► Subscribe
Germany60332212► Subscribe
Canada2492488► Subscribe
BrazilPI0414860► 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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Serving 500+ biopharmaceutical companies globally:

Farmers Insurance
Healthtrust
Boehringer Ingelheim
Cerilliant
Johnson and Johnson
Mallinckrodt
Fuji
Dow
Express Scripts
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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