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Last Updated: October 11, 2024

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 Natco, Purepac Pharm, Pfizer Pharms, Apotex, Ascent Pharms Inc, Aurobindo Pharma Ltd, Cadila, Cadila Pharms Ltd, Caribe Holdings, Chartwell Molecules, Chartwell Rx, Hikma Pharms, Impax Pharms, Invagen Pharms, Northstar Hlthcare, Norvium Bioscience, Sun Pharm Inds Inc, Teva, and Watson Labs, and is included in twenty-one NDAs. Additional information is available in the individual branded drug profile pages.

Thirty-four 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
St. Louis UniversityEarly Phase 1
Polaryx Therapeutics, Inc.Phase 3
Bristol-Myers SquibbPhase 1

See all gemfibrozil clinical trials

Generic filers with tentative approvals for GEMFIBROZIL
Applicant Application No. Strength Dosage Form
⤷  Sign Up⤷  Sign Up300MGCAPSULE;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
Anatomical Therapeutic Chemical (ATC) Classes 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
Impax Pharms GEMFIBROZIL gemfibrozil TABLET;ORAL 078207-001 Jun 1, 2007 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Invagen Pharms GEMFIBROZIL gemfibrozil TABLET;ORAL 077836-001 Jul 27, 2006 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Apotex GEMFIBROZIL gemfibrozil TABLET;ORAL 075034-001 Jul 20, 1998 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Cadila GEMFIBROZIL gemfibrozil TABLET;ORAL 204189-001 Aug 28, 2018 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Pfizer Pharms LOPID gemfibrozil CAPSULE;ORAL 018422-002 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Chartwell Molecules GEMFIBROZIL gemfibrozil TABLET;ORAL 074270-001 Sep 27, 1993 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Northstar Hlthcare GEMFIBROZIL gemfibrozil TABLET;ORAL 079072-001 Sep 13, 2010 AB RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>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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