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Last Updated: July 11, 2020

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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 Atlantis, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Ani Pharms Inc, Apotex, Austarpharma, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Impax Labs, Invagen Pharms, Mylan Pharms Inc, Novast Labs, Rhodes Pharms, Torrent, Abbvie, Cipher Pharms Inc, Alembic Pharms Ltd, Amneal Pharms Llc, Appco, Aurobindo Pharma Ltd, Cipla, Graviti Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Mylan, Orit Labs Llc, Prinston Inc, Sun Pharm, Valeant Pharms North, Salix, Abbvie Inc, and Skyepharma Ag, and is included in forty-five NDAs. There are twelve patents protecting this compound and three Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Fenofibrate has three hundred and twenty-eight patent family members in forty-six countries.

There are forty-two drug master file entries for fenofibrate. Fifty-four 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

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SponsorPhase
National Medical Research Council (NMRC), SingaporePhase 3
Singapore General HospitalPhase 3
Medical University of South CarolinaPhase 4

See all fenofibrate clinical trials

Generic filers with tentative approvals for FENOFIBRATE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial130MGCAPSULE; ORAL
  Start Trial  Start 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 NDA Submissiondate
FENOGLIDE TABLET;ORAL fenofibrate 022118 2010-03-17
ANTARA (MICRONIZED) CAPSULE;ORAL fenofibrate 021695 2008-09-15
TRICOR TABLET;ORAL fenofibrate 021656 2008-07-01
TRICOR TABLET;ORAL fenofibrate 021656 2007-10-19
LIPIDIL CAPSULE;ORAL fenofibrate 019304
TRICOR (MICRONIZED) CAPSULE;ORAL fenofibrate 019304
TRICOR TABLET;ORAL fenofibrate 021203

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
Graviti Pharms FENOFIBRATE fenofibrate TABLET;ORAL 210606-002 Aug 17, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Aurobindo Pharma Ltd FENOFIBRATE fenofibrate TABLET;ORAL 205118-001 May 5, 2016 AB RX No No   Start Trial   Start Trial   Start Trial
Invagen Pharms FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 207378-001 Mar 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Ani Pharms Inc FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 209504-002 Apr 30, 2018 AB RX No No   Start Trial   Start Trial   Start Trial
Ajanta Pharma Ltd FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 210705-001 Sep 10, 2018 AB RX No No   Start Trial   Start Trial   Start 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 Inc TRICOR fenofibrate TABLET;ORAL 021203-001 Sep 4, 2001   Start Trial   Start Trial
Abbvie TRICOR fenofibrate TABLET;ORAL 021656-001 Nov 5, 2004   Start Trial   Start Trial
Abbvie Inc TRICOR fenofibrate TABLET;ORAL 021203-003 Sep 4, 2001   Start Trial   Start Trial
Abbvie Inc TRICOR fenofibrate TABLET;ORAL 021203-003 Sep 4, 2001   Start Trial   Start Trial
Abbvie Inc TRICOR fenofibrate TABLET;ORAL 021203-001 Sep 4, 2001   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

AstraZeneca
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.