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Last Updated: March 19, 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, Youngtech Pharms Inc, 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-two NDAs. There are six patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fenofibrate has thirty-one patent family members in twelve 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
Manal Ali Mahrous Hamouda Faculty of Pharmacy, Menufia UniversityPhase 2
Fedaa Abd El-monem Kamal El-deen Kotkata Faculty of Pharmacy, Tanta UniversityPhase 2
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 Trial130MGCAPSULE; ORAL
⤷  Try a Trial⤷  Try a Trial43MGCAPSULE; 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
Abbvie TRICOR (MICRONIZED) fenofibrate CAPSULE;ORAL 019304-003 Jun 30, 1999 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Hetero Labs Ltd Iii FENOFIBRATE fenofibrate TABLET;ORAL 204598-001 Jul 12, 2016 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Rhodes Pharms FENOFIBRATE fenofibrate TABLET;ORAL 076433-002 May 13, 2005 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Lupin Ltd FENOFIBRATE fenofibrate TABLET;ORAL 090856-001 Dec 23, 2011 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Salix FENOGLIDE fenofibrate TABLET;ORAL 022118-001 Aug 10, 2007 AB RX Yes No ⤷  Try a Trial ⤷  Try a Trial Y ⤷  Try a Trial
Mylan FENOFIBRATE fenofibrate TABLET;ORAL 076520-003 Oct 25, 2007 AB RX No 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 021656-002 Nov 5, 2004 ⤷  Try a Trial ⤷  Try a Trial
Abbvie TRICOR fenofibrate TABLET;ORAL 021203-003 Sep 4, 2001 ⤷  Try a Trial ⤷  Try a Trial
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-003 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
Abbvie TRICOR fenofibrate TABLET;ORAL 021656-002 Nov 5, 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
Russian Federation 2343905 ТВЕРДЫЕ ДОЗИРОВАННЫЕ ФОРМЫ, ВКЛЮЧАЮЩИЕ ФИБРАТ И СТАТИН (SOLID DOSED OUT FORMS INCLUDING FIBRAT AND STATIN) ⤷  Try a Trial
China 1867321 A solid dosage form comprising a fibrate ⤷  Try a Trial
China 100551363 ⤷  Try a Trial
Japan 2007508249 ⤷  Try a Trial
Canada 2582405 COMPOSITIONS PHARMACEUTIQUES CONTENANT DU FENOFIBRATE ET DE L'ATORVASTATINE (PHARMACEUTICAL COMPOSITIONS COMPRISING FENOFIBRATE AND ATORVASTATIN) ⤷  Try a Trial
China 1874758 Compositions comprising fenofibrate and pravastatin ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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