Last Updated: November 9, 2026

ANTIZOL Drug Patent Profile

Name: ANTIZOL Drug Patent, Exclusivity, and Generic Launch Dataset
Creator: DrugPatentWatch
License: https://www.drugpatentwatch.com/terms.php

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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.

The generic ingredient in ANTIZOL is fomepizole. There is one drug master file entry 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 14^th, 2007.

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Summary for ANTIZOL

US Patents:	1
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	103
Clinical Trials:	2
Patent Applications:	3,563
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

Sponsor	Phase
Ted Daley, President	Phase 2
Raptor Pharmaceuticals Inc.	Phase 2
Horizon Pharma USA, Inc.	Phase 2

See all ANTIZOL clinical trials

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.

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Glossary

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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	⤷ Start Trial	⤷ Start Trial	Y	Y		⤷ Start 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.

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Country	Patent Number	Title	Estimated Expiration
Australia	2006240490	Process for the preparation of ultrapure 4-methylprazole	⤷ Start Trial
Canada	2605413	4-METHYLPYRAZOLE ULTRAPUR (PROCESS FOR THE PREPARATION OF ULTRAPURE 4-METHYLPYRAZOLE)	⤷ Start Trial
China	101163679	Method of preparing ultrapure 4-methylpyrazole	⤷ Start Trial
European Patent Office	1948613	PROCEDE POUR LA PREPARATION DE LA 4-METHYLPYRAZOLE ULTRAPURE (PROCESS FOT THE PREPARATION OF ULTRAPURE 4-METHYLPYRAZOLE)	⤷ Start Trial
Japan	2008538560		⤷ Start Trial
Japan	5378788		⤷ Start Trial
South Korea	20080000660	PROCESS FOR THE PREPARATION OF ULTRAPURE 4-METHYLPYRAZOLE	⤷ Start 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. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. 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.