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Last Updated: June 27, 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-two suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for FENOFIBRATE

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Drug Sales Revenue Trends for FENOFIBRATE

See drug sales revenues for FENOFIBRATE

Recent Clinical Trials for FENOFIBRATE

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

SponsorPhase
Seoul National University Bundang HospitalPhase 4
University of MinnesotaPhase 2
University of MichiganPhase 2

See all FENOFIBRATE clinical trials

Generic filers with tentative approvals for FENOFIBRATE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing130MGCAPSULE; ORAL
See Plans and PricingSee Plans and Pricing43MGCAPSULE; ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for FENOFIBRATE
Medical Subject Heading (MeSH) Categories 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
Mylan FENOFIBRATE fenofibrate TABLET;ORAL 076520-003 Oct 25, 2007 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Dr Reddys FENOFIBRATE fenofibrate TABLET;ORAL 210670-001 Sep 6, 2019 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Graviti Pharms FENOFIBRATE fenofibrate TABLET;ORAL 211122-002 Mar 18, 2020 AB RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Invagen Pharms FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 207378-001 Mar 28, 2017 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 (MICRONIZED) fenofibrate CAPSULE;ORAL 019304-003 Jun 30, 1999 See Plans and Pricing See Plans and Pricing
Abbvie TRICOR (MICRONIZED) fenofibrate CAPSULE;ORAL 019304-004 Jun 30, 1999 See Plans and Pricing See Plans and Pricing
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-002 Nov 30, 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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FENOFIBRATE

Country Patent Number Title Estimated Expiration
Argentina 072134 COMPOSICIONES DE NANOPARTICULAS DE INHIBIDORES DE ANGIOGENESIS See Plans and Pricing
Japan 4842514 See Plans and Pricing
European Patent Office 1471887 COMPOSITIONS NANOPARTICULAIRES A STABILISATEUR SUPERFICIEL DE LYSOZYME (NANOPARTICULATE COMPOSITIONS HAVING LYSOZYME AS A SURFACE STABILIZER) See Plans and Pricing
Denmark 2263652 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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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 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.