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Last Updated: September 22, 2020

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Gemfibrozil - Generic Drug Details

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What are the generic sources for gemfibrozil and what is the scope of freedom to operate?

Gemfibrozil is the generic ingredient in two branded drugs marketed by Mylan, Purepac Pharm, Pfizer Pharms, Apotex, Aurobindo Pharma Ltd, Cadila, Cadila Pharms Ltd, Caribe Holdings, Chartwell Molecules, Hikma Pharms, Impax Pharms, Invagen Pharms, Northstar Hlthcare, Sun Pharm Inds Inc, Teva, Watson Labs, and Yaopharma Co Ltd, and is included in twenty NDAs. Additional information is available in the individual branded drug profile pages.

Twenty-five suppliers are listed for this compound. There is one tentative approval for this compound.

Drug Prices for gemfibrozil

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Drug Sales Revenue Trends for gemfibrozil

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Recent Clinical Trials for gemfibrozil

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SponsorPhase
Seattle Genetics, Inc.Phase 1
CelgenePhase 1
Instituto Nacional de Salud Publica, MexicoPhase 3

See all gemfibrozil clinical trials

Generic filers with tentative approvals for GEMFIBROZIL
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial300MGCAPSULE;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Medical Subject Heading (MeSH) Categories for gemfibrozil

US Patents and Regulatory Information for gemfibrozil

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Yaopharma Co Ltd GEMFIBROZIL gemfibrozil TABLET;ORAL 074615-001 Sep 29, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Watson Labs GEMFIBROZIL gemfibrozil TABLET;ORAL 074442-001 Apr 28, 1995 DISCN No No   Start Trial   Start Trial   Start Trial
Purepac Pharm GEMFIBROZIL gemfibrozil CAPSULE;ORAL 072929-001 Jan 29, 1993 DISCN No No   Start Trial   Start Trial   Start Trial
Sun Pharm Inds Inc GEMFIBROZIL gemfibrozil TABLET;ORAL 079239-001 Dec 29, 2008 DISCN No No   Start Trial   Start Trial   Start Trial
Apotex GEMFIBROZIL gemfibrozil TABLET;ORAL 075034-001 Jul 20, 1998 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 gemfibrozil

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer Pharms LOPID gemfibrozil CAPSULE;ORAL 018422-001 Approved Prior to Jan 1, 1982   Start Trial   Start Trial
Pfizer Pharms LOPID gemfibrozil CAPSULE;ORAL 018422-002 Approved Prior to Jan 1, 1982   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:

McKinsey
Boehringer Ingelheim
Express Scripts
Colorcon
Medtronic
McKesson

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