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Last Updated: December 8, 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, Chartwell, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Norvium Bioscience, Novast Labs, Reyoung, Rhodes Pharms, Rising, Torrent, Abbvie, Cipher Pharms Inc, Amneal, Aurobindo Pharma, Austarpharma, Chartwell Rx, Cipla, Creekwood Pharms, Dr Reddys, Hetero Labs Ltd Iii, Lupin Ltd, Mankind Pharma, Mylan, Mylan Pharms Inc, Prinston Inc, Sun Pharm, Valeant Pharms North, Yichang Humanwell, Salix, and Skyepharma Ag, and is included in fifty-three 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-four 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
Lindsay Ferguson, MDPhase 1
Tanta UniversityPhase 4
Han YingPhase 2/Phase 3

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
Mankind Pharma FENOFIBRATE fenofibrate TABLET;ORAL 213864-001 Jun 12, 2020 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Yichang Humanwell FENOFIBRATE fenofibrate TABLET;ORAL 218548-002 Apr 24, 2024 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cipher Pharms Inc LIPOFEN fenofibrate CAPSULE;ORAL 021612-002 Jan 11, 2006 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm FENOFIBRATE fenofibrate TABLET;ORAL 200884-002 Sep 7, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Sun Pharm FENOFIBRATE fenofibrate TABLET;ORAL 200884-001 Sep 7, 2017 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Torrent FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 210782-003 Jun 26, 2018 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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
Salix FENOGLIDE fenofibrate TABLET;ORAL 022118-002 Aug 10, 2007 ⤷  Sign Up ⤷  Sign Up
Skyepharma Ag TRIGLIDE fenofibrate TABLET;ORAL 021350-002 May 7, 2005 ⤷  Sign Up ⤷  Sign Up
Abbvie TRICOR fenofibrate TABLET;ORAL 021203-003 Sep 4, 2001 ⤷  Sign Up ⤷  Sign Up
Cipher Pharms Inc LIPOFEN fenofibrate CAPSULE;ORAL 021612-002 Jan 11, 2006 ⤷  Sign Up ⤷  Sign Up
Abbvie TRICOR (MICRONIZED) fenofibrate CAPSULE;ORAL 019304-004 Jun 30, 1999 ⤷  Sign Up ⤷  Sign Up
Skyepharma Ag TRIGLIDE fenofibrate TABLET;ORAL 021350-001 May 7, 2005 ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for fenofibrate

Country Patent Number Title Estimated Expiration
World Intellectual Property Organization (WIPO) 2006037344 ⤷  Sign Up
World Intellectual Property Organization (WIPO) 2006037347 ⤷  Sign Up
Canada 2582405 COMPOSITIONS PHARMACEUTIQUES CONTENANT DU FENOFIBRATE ET DE L'ATORVASTATINE (PHARMACEUTICAL COMPOSITIONS COMPRISING FENOFIBRATE AND ATORVASTATIN) ⤷  Sign Up
China 1867321 A solid dosage form comprising a fibrate ⤷  Sign Up
Japan 2007508249 ⤷  Sign Up
Canada 2541382 FORME POSOLOGIQUE SOLIDE COMPRENANT UNE FIBRATE ET UNE STATINE (A SOLID DOSAGE FORM COMPRISING A FIBRATE AND A STATIN) ⤷  Sign Up
>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.