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Last Updated: May 26, 2022

Fenofibrate - Generic Drug Details


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

Fenofibrate is the generic ingredient in nine branded drugs marketed by Lupin, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Alembic Pharms Ltd, Ani Pharms, Apotex, Aurobindo Pharma Ltd, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Mylan Pharms Inc, Novast Labs, Reyoung, Rhodes Pharms, Rising, Torrent, Abbvie, Cipher Pharms Inc, Adaptis, Alembic Labs, Amneal, Austarpharma, Cipla, Dr Reddys, Graviti Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Mankind Pharma, Mylan, Prinston Inc, Sun Pharm, Valeant Pharms North, Salix, Abbvie Inc, and Skyepharma Ag, and is included in forty-nine NDAs. There are eight patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fenofibrate has one hundred and ninety-five patent family members in thirty countries.

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

Drug Prices for fenofibrate

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Drug Sales Revenue Trends for fenofibrate

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Recent Clinical Trials for fenofibrate

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Seoul National University Bundang HospitalPhase 4
University of MichiganPhase 2
Alessandro DoriaPhase 2

See all fenofibrate clinical trials

Pharmacology for fenofibrate
Medical Subject Heading (MeSH) Categories for fenofibrate
Anatomical Therapeutic Chemical (ATC) Classes for fenofibrate
Paragraph IV (Patent) Challenges for FENOFIBRATE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
FENOGLIDE Tablets fenofibrate 40 mg and 120 mg 022118 1 2010-03-17
ANTARA (MICRONIZED) Capsules fenofibrate 43 mg and 130 mg 021695 1 2008-09-15
TRICOR Tablets fenofibrate 48 mg 021656 1 2008-07-01
TRICOR Tablets fenofibrate 145 mg 021656 1 2007-10-19

US Patents and Regulatory Information for fenofibrate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Dr Reddys Labs Sa FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 090859-002 Mar 1, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Ani Pharms FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 209504-001 Apr 30, 2018 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys Labs Sa FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 090859-001 Mar 1, 2012 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-002 Nov 30, 2004 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Apotex FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 202252-001 Jul 26, 2013 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for fenofibrate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Abbvie TRICOR fenofibrate TABLET;ORAL 021656-002 Nov 5, 2004 See Plans and Pricing See Plans and Pricing
Abbvie Inc TRICOR fenofibrate TABLET;ORAL 021203-003 Sep 4, 2001 See Plans and Pricing See Plans and Pricing
Abbvie Inc TRICOR fenofibrate TABLET;ORAL 021203-001 Sep 4, 2001 See Plans and Pricing See Plans and Pricing
Skyepharma Ag TRIGLIDE fenofibrate TABLET;ORAL 021350-002 May 7, 2005 See Plans and Pricing See Plans and Pricing
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-003 Nov 30, 2004 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for fenofibrate

Country Patent Number Title Estimated Expiration
Taiwan 201006466 Fenofibrate dosage forms See Plans and Pricing
Australia 2003230691 NANOPARTICULATE COMPOSITIONS OF ANGIOGENESIS INHIBITORS See Plans and Pricing
Australia 2008264174 Nanoparticulate fibrate formulations See Plans and Pricing
Argentina 111501 COMPOSICIÓN FARMACÉUTICA DE FENOFIBRATO Y MÉTODO PARA PREPARARLA See Plans and Pricing
European Patent Office 1680091 FORME DE DOSE SOLIDE COMPRENANT UN FIBRATE (A SOLID DOSAGE FORM COMPRISING A FIBRATE) See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

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Medtronic
McKesson
Harvard Business School
Boehringer Ingelheim
Express Scripts

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 verification 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.