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Serving leading biopharmaceutical companies globally:

Colorcon
Julphar
US Department of Justice
Fuji
McKinsey
Boehringer Ingelheim
Daiichi Sankyo
US Army
McKesson
Chinese Patent Office

Generated: December 15, 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 Lupin Atlantis, Sun Pharm Inds Ltd, Apotex Inc, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Mylan Pharms Inc, Rhodes Pharms, Abbvie, Cipher Pharms Inc, 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 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 seventeen 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.

Medical Subject Heading (MeSH) Categories for 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 Patent Submitted Product Substance Delist Req. Exclusivity Expiration
Mylan Pharms IncFENOFIBRATEfenofibrateTABLET;ORAL202856-002Dec 7, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
MylanFENOFIBRATEfenofibrateTABLET;ORAL204475-002Jun 23, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
MylanFENOFIBRATEfenofibrateTABLET;ORAL204475-001Jun 23, 2016ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Sun Pharm Inds LtdFENOFIBRATEfenofibrateCAPSULE;ORAL201748-002Oct 31, 2014ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Valeant Pharms NorthFENOFIBRATEfenofibrateTABLET;ORAL090715-001Apr 5, 2012ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Impax LabsFENOFIBRATE (MICRONIZED)fenofibrateCAPSULE;ORAL075868-002Oct 27, 2003ABRXNoNo► Subscribe► Subscribe► Subscribe► Subscribe
Lupin AtlantisANTARA (MICRONIZED)fenofibrateCAPSULE;ORAL021695-003Nov 30, 2004ABRXYesYes► Subscribe► Subscribe► SubscribeYY► Subscribe
Abbvie IncTRICORfenofibrateTABLET;ORAL021203-001Sep 4, 2001DISCNYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
AbbvieTRICORfenofibrateTABLET;ORAL021656-001Nov 5, 2004ABRXYesNo► Subscribe► Subscribe► SubscribeY► Subscribe
Impax LabsFENOFIBRATEfenofibrateTABLET;ORAL076509-001Mar 26, 2008ABRXNoNo► Subscribe► 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
Abbvie IncTRICORfenofibrateTABLET;ORAL021203-003Sep 4, 2001► Subscribe► Subscribe
AbbvieTRICORfenofibrateTABLET;ORAL021656-001Nov 5, 2004► Subscribe► Subscribe
AbbvieTRICOR (MICRONIZED)fenofibrateCAPSULE;ORAL019304-002Feb 9, 1998► Subscribe► Subscribe
Lupin AtlantisANTARA (MICRONIZED)fenofibrateCAPSULE;ORAL021695-001Nov 30, 2004► Subscribe► Subscribe
AbbvieLIPIDILfenofibrateCAPSULE;ORAL019304-001Dec 31, 1993► Subscribe► Subscribe
AbbvieTRICOR (MICRONIZED)fenofibrateCAPSULE;ORAL019304-003Jun 30, 1999► Subscribe► Subscribe
Cipher Pharms IncLIPOFENfenofibrateCAPSULE;ORAL021612-001Jan 11, 2006► Subscribe► Subscribe
Lupin AtlantisANTARA (MICRONIZED)fenofibrateCAPSULE;ORAL021695-002Nov 30, 2004► Subscribe► Subscribe
Cipher Pharms IncLIPOFENfenofibrateCAPSULE;ORAL021612-002Jan 11, 2006► Subscribe► Subscribe
Abbvie IncTRICORfenofibrateTABLET;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
7,772,273Stabilized atorvastatin► Subscribe
8,293,277Controlled-release nanoparticulate compositions► Subscribe
7,198,795In vitro methods for evaluating the in vivo effectiveness of dosage forms of microparticulate of nanoparticulate active agent compositions► Subscribe
7,244,451Methods of making nanoparticulate drug compositions comprising copolymers of vinyl pyrrolidone and vinyl acetate as surface stabilizers► Subscribe
8,586,094Coated tablets► Subscribe
6,969,529 Nanoparticulate compositions comprising copolymers of vinyl pyrrolidone and vinyl acetate as surface stabilizers► Subscribe
7,927,627Nanoparticulate fibrate formulations► Subscribe
8,703,202Coated tablets► Subscribe
6,811,767 Liquid droplet aerosols of nanoparticulate drugs► Subscribe
8,529,952Pharmaceutical composition containing fenofibrate and method for the preparation thereof► 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
Germany60019774► Subscribe
Spain2263714► Subscribe
Japan2003511406► Subscribe
Taiwan200942272► Subscribe
South Korea20060085686► Subscribe
Portugal2263652► Subscribe
Uruguay27822► Subscribe
Portugal1194140► Subscribe
Hong Kong1096034► Subscribe
European Patent Office1804768► 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 leading biopharmaceutical companies globally:

Novartis
Colorcon
Accenture
Covington
Johnson and Johnson
Deloitte
Queensland Health
Healthtrust
AstraZeneca
Merck

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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