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Last Updated: March 19, 2024

FOMEPIZOLE Drug Patent Profile


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DrugPatentWatch® Litigation and Generic Entry Outlook for Fomepizole

A generic version of FOMEPIZOLE was approved as fomepizole by AM REGENT on December 14th, 2007.

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Drug patent expirations by year for FOMEPIZOLE
Drug Prices for FOMEPIZOLE

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Recent Clinical Trials for FOMEPIZOLE

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SponsorPhase
Richard Dart, MD, PhDPhase 2
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionPhase 2
University of ArizonaEarly Phase 1

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Pharmacology for FOMEPIZOLE
Drug ClassAntidote
Anatomical Therapeutic Chemical (ATC) Classes for FOMEPIZOLE
Paragraph IV (Patent) Challenges for FOMEPIZOLE
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
ANTIZOL Injection fomepizole 1.5 g/1.5 mL 020696 1 2021-11-01
ANTIZOL Injection fomepizole 1.5 g/1.5 mL 020696 1 2014-04-14

US Patents and Regulatory Information for FOMEPIZOLE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Regent FOMEPIZOLE fomepizole INJECTABLE;INJECTION 078368-001 Dec 14, 2007 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Institutional FOMEPIZOLE fomepizole INJECTABLE;INJECTION 078639-001 Mar 3, 2008 AP RX No Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Gland Pharma Ltd FOMEPIZOLE fomepizole INJECTABLE;INJECTION 216791-001 Jul 6, 2023 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Mylan Institutional FOMEPIZOLE fomepizole INJECTABLE;INJECTION 079033-001 Apr 7, 2009 DISCN No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Navinta Llc FOMEPIZOLE fomepizole INJECTABLE;INJECTION 078537-001 Mar 6, 2008 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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