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Fenofibrate - Generic Drug Details

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Fenofibrate is the generic ingredient in nine branded drugs marketed by Abbott, Abbvie, Impax Labs, Cipher Pharms Inc, Valeant Pharms North, Aurobindo Pharma Ltd, Santarus Inc, Lupin Ltd, Mylan, Teva, 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-five 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-six suppliers are listed for this compound. There is one tentative approval for this compound.

Summary for Generic Name: fenofibrate

Tradenames:9
Patents:18
Applicants:17
NDAs:25
Drug Master File Entries: see list41
Suppliers / Packaging: see list46
Therapeutic Class:Cardiovascular Agents
Formulation / Manufacturing:see details
Drug Prices:see low prices

Pharmacology for Ingredient: fenofibrate

Tentative approvals for FENOFIBRATE

Applicant Application No. Form Dosage
<disabled><disabled>CAPSULE; ORAL43MG
<disabled><disabled>CAPSULE; ORAL130MG
Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Abbvie
TRICOR
fenofibrate
TABLET;ORAL021656-001Nov 5, 2004RXNo7,041,319► subscribeY ► subscribe
Mylan Pharms Inc
FENOFIBRATE
fenofibrate
TABLET;ORAL202856-002Dec 7, 2012RXNo► subscribe► subscribe
Impax Labs
FENOFIBRATE (MICRONIZED)
fenofibrate
CAPSULE;ORAL075868-001Oct 27, 2003RXNo► 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;ORAL021656-001Nov 5, 20045,145,684► subscribe
Lupin Atlantis
ANTARA (MICRONIZED)
fenofibrate
CAPSULE;ORAL021695-002Nov 30, 20044,800,079► 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
6,534,088 Fibrate-statin combinations with reduced fed-fasted effects► subscribe
7,288,267Bioadhesive nanoparticulate compositions having cationic surface stabilizers► 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
World Intellectual Property Organization (WIPO)2006037344► subscribe
New Zealand587658► subscribe
Australia2003301807► 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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