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Last Updated: August 5, 2021

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FENOFIBRATE Drug Patent 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 Labs, Alembic Pharms Ltd, Amneal, Aurobindo Pharma Ltd, Austarpharma, Cipla, Dr Reddys, Graviti Pharms, Hetero Labs Ltd Iii, Impax Labs, Lupin Ltd, Mankind Pharma, Mylan, Mylan Pharms Inc, Prinston Inc, Rhodes Pharms, Sun Pharm, Valeant Pharms North, Ani Pharms, Apotex, Dr Reddys Labs Sa, Glenmark Pharms Ltd, Invagen Pharms, Novast Labs, and Torrent. and is included in forty-one NDAs.

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

DrugPatentWatch® 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

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

SponsorPhase
The Lowy Medical Research Institute LimitedPhase 2
Laboratorios Silanes S.A. de C.V.Phase 3
Shaheed Zulfiqar Ali Bhutto Medical UniversityN/A

See all FENOFIBRATE clinical trials

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
Dr Reddys Labs Sa FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 090859-002 Mar 1, 2012 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan FENOFIBRATE fenofibrate TABLET;ORAL 076520-003 Oct 25, 2007 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Impax Labs FENOFIBRATE fenofibrate TABLET;ORAL 076509-002 Mar 26, 2008 AB RX No Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Pharms Inc FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 202676-003 Oct 23, 2012 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Rhodes Pharms FENOFIBRATE fenofibrate TABLET;ORAL 076433-002 May 13, 2005 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Alembic Pharms Ltd FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 213842-001 Oct 19, 2020 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Colorcon
Medtronic
Dow
Merck
Boehringer Ingelheim

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