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Last Updated: May 18, 2024

ANTIZOL Drug Patent Profile


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Which patents cover Antizol, and when can generic versions of Antizol launch?

Antizol is a drug marketed by Par Pharm Inc and is included in one NDA. There is one patent protecting this drug and two Paragraph IV challenges.

This drug has nine patent family members in eight countries.

The generic ingredient in ANTIZOL is fomepizole. There are five drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the fomepizole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Antizol

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

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Summary for ANTIZOL
International Patents:9
US Patents:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 163
Clinical Trials: 2
Patent Applications: 1,735
Formulation / Manufacturing:see details
What excipients (inactive ingredients) are in ANTIZOL?ANTIZOL excipients list
DailyMed Link:ANTIZOL at DailyMed
Drug patent expirations by year for ANTIZOL
Recent Clinical Trials for ANTIZOL

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

SponsorPhase
Ted Daley, PresidentPhase 2
Raptor Pharmaceuticals Inc.Phase 2
Horizon Pharma USA, Inc.Phase 2

See all ANTIZOL clinical trials

Anatomical Therapeutic Chemical (ATC) Classes for ANTIZOL
Paragraph IV (Patent) Challenges for ANTIZOL
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 ANTIZOL

ANTIZOL is protected by one US patents.

Patents protecting ANTIZOL

Ultrapure 4-methylpyrazole
Patent Number: ⤷  Try a Trial
Patent Expiration: ⤷  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
Par Pharm Inc ANTIZOL fomepizole INJECTABLE;INJECTION 020696-001 Dec 4, 1997 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial Y Y ⤷  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

International Patents for ANTIZOL

See the table below for patents covering ANTIZOL around the world.

Country Patent Number Title Estimated Expiration
European Patent Office 1948613 PROCEDE POUR LA PREPARATION DE LA 4-METHYLPYRAZOLE ULTRAPURE (PROCESS FOT THE PREPARATION OF ULTRAPURE 4-METHYLPYRAZOLE) ⤷  Try a Trial
Canada 2605413 4-METHYLPYRAZOLE ULTRAPUR (PROCESS FOR THE PREPARATION OF ULTRAPURE 4-METHYLPYRAZOLE) ⤷  Try a Trial
Mexico 2007013118 PROCESO PARA LA PREPARACION DE 4-METILPIRAZOL ULTRAPURO. (PROCESS FOR THE PREPARATION OF ULTRAPURE 4-METHYLPRAZOLE.) ⤷  Try a Trial
World Intellectual Property Organization (WIPO) 2006115626 ⤷  Try a Trial
>Country >Patent Number >Title >Estimated Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.