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Last Updated: August 10, 2020

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FENOFIBRATE Drug Profile

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When do Fenofibrate patents expire, and what generic alternatives are available?

Fenofibrate is a drug marketed by Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Alembic Pharms Ltd, Amneal Pharms Llc, Appco, Aurobindo Pharma Ltd, Austarpharma, Cipla, Graviti Pharms, Hetero Labs Ltd Iii, Impax Labs, Lupin Ltd, Mankind Pharma, Mylan, Mylan Pharms Inc, Orit Labs Llc, Prinston Inc, Rhodes Pharms, Sun Pharm, Valeant Pharms North, Ani Pharms Inc, Apotex, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Invagen Pharms, Novast Labs, and Torrent. and is included in thirty-nine NDAs.

The generic ingredient in FENOFIBRATE is fenofibrate. There are forty-two drug master file entries for this compound. Fifty-five suppliers are listed for this compound. Additional details are available on the fenofibrate profile page.

US ANDA Litigation and Generic Entry Outlook for Fenofibrate

A generic version of FENOFIBRATE was approved as fenofibrate by RHODES PHARMS on May 13th, 2005.

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Drug patent expirations by year for FENOFIBRATE
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

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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
TRICOR TABLET;ORAL fenofibrate 021203
LIPIDIL CAPSULE;ORAL fenofibrate 019304
TRICOR (MICRONIZED) CAPSULE;ORAL fenofibrate 019304

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 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc FENOFIBRATE fenofibrate TABLET;ORAL 202856-002 Dec 7, 2012 AB RX No No   Start Trial   Start Trial   Start Trial
Lupin Ltd FENOFIBRATE fenofibrate TABLET;ORAL 204019-002 Aug 17, 2015 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

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