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 14^th, 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
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
Horizon Pharma USA, Inc.	Phase 2
Ted Daley, President	Phase 2
Raptor Pharmaceuticals 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.

Patents protecting ANTIZOL

Ultrapure 4-methylpyrazole
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Patent Expiration: ⤷ Sign Up

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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	⤷ Sign Up	⤷ Sign Up	Y	Y		⤷ Sign Up
>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
Mexico	2007013118	PROCESO PARA LA PREPARACION DE 4-METILPIRAZOL ULTRAPURO. (PROCESS FOR THE PREPARATION OF ULTRAPURE 4-METHYLPRAZOLE.)	⤷ Sign Up
South Korea	20080000660	PROCESS FOR THE PREPARATION OF ULTRAPURE 4-METHYLPYRAZOLE	⤷ Sign Up
Canada	2605413	4-METHYLPYRAZOLE ULTRAPUR (PROCESS FOR THE PREPARATION OF ULTRAPURE 4-METHYLPYRAZOLE)	⤷ Sign Up
Japan	2008538560		⤷ Sign Up
>Country	>Patent Number	>Title	>Estimated Expiration