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Last Updated: February 22, 2024

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, 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, Amneal, Aurobindo Pharma, Austarpharma, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Graviti Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Mankind Pharma, Mylan, Prinston Inc, Sun Pharm, Valeant Pharms North, Salix, and Skyepharma Ag, and is included in fifty-one 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-one 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

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Recent Clinical Trials for FENOFIBRATE

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

SponsorPhase
Eman Ibrahim Elberri, Faculty of Pharmacy, Tanta UniversityPhase 2
Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia UniversityPhase 2
Fedaa Abd El-monem Kamal El-deen Kotkata Faculty of Pharmacy, Tanta UniversityPhase 2

See all FENOFIBRATE clinical trials

Generic filers with tentative approvals for FENOFIBRATE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial43MGCAPSULE; ORAL
⤷  Try a Trial⤷  Try a Trial130MGCAPSULE; 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
Impax Labs FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 075868-002 Oct 27, 2003 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Reyoung FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 207805-001 Nov 16, 2017 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Austarpharma FENOFIBRATE fenofibrate TABLET;ORAL 208476-002 Feb 10, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-002 Nov 30, 2004 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cipher Pharms Inc LIPOFEN fenofibrate CAPSULE;ORAL 021612-002 Jan 11, 2006 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Abbvie TRICOR fenofibrate TABLET;ORAL 021656-001 Nov 5, 2004 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
>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 021203-003 Sep 4, 2001 ⤷  Try a Trial ⤷  Try a Trial
Skyepharma Ag TRIGLIDE fenofibrate TABLET;ORAL 021350-001 May 7, 2005 ⤷  Try a Trial ⤷  Try a Trial
Abbvie TRICOR (MICRONIZED) fenofibrate CAPSULE;ORAL 019304-003 Jun 30, 1999 ⤷  Try a Trial ⤷  Try a Trial
Abbvie TRICOR fenofibrate TABLET;ORAL 021656-001 Nov 5, 2004 ⤷  Try a Trial ⤷  Try a Trial
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-001 Nov 30, 2004 ⤷  Try a Trial ⤷  Try a Trial
Abbvie TRICOR fenofibrate TABLET;ORAL 021203-001 Sep 4, 2001 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for FENOFIBRATE

Country Patent Number Title Estimated Expiration
Australia 9501701 Solid dose nanoparticulate compositions ⤷  Try a Trial
Japan 2011514360 ⤷  Try a Trial
Switzerland 707330 Composizioni farmaceutiche a dose ridotta di fenofibrato. ⤷  Try a Trial
Canada 2416109 COMPOSITIONS NANOPARTICULAIRES A DOSES SOLIDES (SOLID DOSE NANOPARTICULATE COMPOSITIONS) ⤷  Try a Trial
Argentina 111501 COMPOSICIÓN FARMACÉUTICA DE FENOFIBRATO Y MÉTODO PARA PREPARARLA ⤷  Try a Trial
Canada 2492488 COMPOSITIONS POUR DOSES LIQUIDES D'AGENTS ACTIFS NANOPARTICULAIRES STABLES (LIQUID DOSAGE COMPOSITIONS OF STABLE NANOPARTICULATE ACTIVE AGENTS) ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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