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Last Updated: May 26, 2022

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 one Paragraph IV challenge.

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. Four 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: 153
Clinical Trials: 2
Patent Applications: 2,037
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
Horizon Pharma USA, Inc.Phase 2
Ted Daley, PresidentPhase 2
Raptor Pharmaceuticals 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

US Patents and Regulatory Information for ANTIZOL

ANTIZOL is protected by one US patents.

Patents protecting ANTIZOL

Ultrapure 4-methylpyrazole
Patent Number: See Plans and Pricing
Patent Expiration: See Plans and Pricing

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 See Plans and Pricing See Plans and Pricing Y Y See Plans and Pricing
>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
China 101163679 Method of preparing ultrapure 4-methylpyrazole See Plans and Pricing
European Patent Office 1948613 PROCEDE POUR LA PREPARATION DE LA 4-METHYLPYRAZOLE ULTRAPURE (PROCESS FOT THE PREPARATION OF ULTRAPURE 4-METHYLPYRAZOLE) See Plans and Pricing
World Intellectual Property Organization (WIPO) 2006115626 See Plans and Pricing
Australia 2006240490 Process for the preparation of ultrapure 4-methylprazole See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Mallinckrodt
Express Scripts
Colorcon
Merck
McKinsey
AstraZeneca

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.