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Fenofibrate - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for fenofibrate?

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, Lupin Atlantis, and Hetero Labs Ltd Iii, and is included in twenty-six NDAs. There are eighteen patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

This ingredient has three hundred and eighty-six patent family members in forty-nine countries.

There are forty-one drug master file entries for fenofibrate. Forty-nine suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: fenofibrate

Tradenames:9
Patents:19
Applicants:18
NDAs:26
Drug Master File Entries: see list41
Suppliers / Packagers: see list49
Bulk Api Vendors: see list80
Clinical Trials: see list35
Patent Applications: see list5,163
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. Form Dosage
► Subscribe► SubscribeCAPSULE; ORAL43MG
► Subscribe► SubscribeCAPSULE; ORAL130MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-003Nov 30, 2004RXYesYes7,863,331► Subscribe ► Subscribe
Impax Labs
FENOFIBRATE
fenofibrate
TABLET;ORAL076509-001Mar 26, 2008RXNoNo► Subscribe► Subscribe
Lupin Ltd
FENOFIBRATE
fenofibrate
TABLET;ORAL204019-002Aug 17, 2015RXNoNo► Subscribe► Subscribe
Abbvie
TRICOR
fenofibrate
TABLET;ORAL021656-001Nov 5, 2004RXYesNo7,041,319► SubscribeY ► Subscribe
Mylan
FENOFIBRATE
fenofibrate
TABLET;ORAL204475-002Jun 23, 2016RXNoNo► 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
TRICOR
fenofibrate
TABLET;ORAL021656-002Nov 5, 20045,145,684► Subscribe
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-001Nov 30, 20044,800,079► Subscribe
Abbvie
LIPIDIL
fenofibrate
CAPSULE;ORAL019304-001Dec 31, 19934,058,552► Subscribe
Cipher Pharms Inc
LIPOFEN
fenofibrate
CAPSULE;ORAL021612-001Jan 11, 20065,545,628► Subscribe
Abbott
TRICOR
fenofibrate
TABLET;ORAL021203-001Sep 4, 20014,895,726► 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
8,329,214Process for producing fenofibrate tablets► Subscribe
7,198,795In vitro methods for evaluating the in vivo effectiveness of dosage forms of microparticulate of nanoparticulate active agent compositions► Subscribe
6,592,903 Nanoparticulate dispersions comprising a synergistic combination of a polymeric surface stabilizer and dioctyl sodium sulfosuccinate► Subscribe
8,703,202Coated tablets► Subscribe
7,521,068Dry powder aerosols of nanoparticulate drugs► 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
Hong Kong1080391► Subscribe
Portugal2050445► Subscribe
Denmark1128814► Subscribe
Canada2346001► Subscribe
Australia2009201881► 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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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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