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Last Updated: April 19, 2021

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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, Sun Pharm Inds Ltd, Ajanta Pharma Ltd, Alembic Pharms 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 Labs, Amneal, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Graviti Pharms, Hetero Labs Ltd Iii, Lupin Ltd, Mankind Pharma, Mylan, Prinston Inc, Sun Pharm, Valeant Pharms North, Salix, Abbvie Inc, and Skyepharma Ag, and is included in forty-seven 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 thirty 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

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

SponsorPhase
National Institutes of Health (NIH)Phase 3
Roche Pharma AGPhase 3
Juvenile Diabetes Research FoundationPhase 3

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
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
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-005 Oct 18, 2013 RX Yes Yes   Start Trial   Start Trial   Start Trial
Invagen Pharms FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 207378-002 Mar 28, 2017 AB RX No No   Start Trial   Start Trial   Start Trial
Abbvie Inc TRICOR fenofibrate TABLET;ORAL 021203-001 Sep 4, 2001 DISCN Yes No   Start Trial   Start Trial   Start Trial
Alembic Pharms Ltd FENOFIBRATE fenofibrate TABLET;ORAL 210476-001 Aug 9, 2019 AB RX No No   Start Trial   Start Trial   Start Trial
Mylan Pharms Inc FENOFIBRATE (MICRONIZED) fenofibrate CAPSULE;ORAL 202579-001 Jan 10, 2013 DISCN No No   Start Trial   Start Trial   Start Trial
Mylan FENOFIBRATE fenofibrate TABLET;ORAL 076520-003 Oct 25, 2007 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
Lupin ANTARA (MICRONIZED) fenofibrate CAPSULE;ORAL 021695-001 Nov 30, 2004   Start Trial   Start Trial
Abbvie TRICOR fenofibrate TABLET;ORAL 021656-002 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 021203-001 Sep 4, 2001   Start Trial   Start Trial
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
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Express Scripts

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