Fomepizole - Generic Drug Details

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What are the generic drug sources for fomepizole and what is the scope of freedom to operate?

Fomepizole is the generic ingredient in two branded drugs marketed by Par Pharm Inc, Am Regent, Gland Pharma Ltd, Mylan Institutional, and Navinta Llc, and is included in six NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Fomepizole has nine patent family members in eight countries.

There are five drug master file entries for fomepizole. Six suppliers are listed for this compound.

Summary for fomepizole

International Patents:	9
US Patents:	1
Tradenames:	2
Applicants:	5
NDAs:	6
Drug Master File Entries:	5
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	163
Clinical Trials:	5
Patent Applications:	3,087
Drug Prices:	Drug price trends for fomepizole
What excipients (inactive ingredients) are in fomepizole?	fomepizole excipients list
DailyMed Link:	fomepizole at DailyMed

See drug prices for fomepizole

Recent Clinical Trials for fomepizole

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

Sponsor	Phase
Richard Dart, MD, PhD	Phase 2
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division	Phase 2
University of Arizona	Early Phase 1

See all fomepizole clinical trials

Pharmacology for fomepizole

Drug Class	Antidote

Anatomical Therapeutic Chemical (ATC) Classes for fomepizole

V03AB	Antidotes
V03A	ALL OTHER THERAPEUTIC PRODUCTS
V03	ALL OTHER THERAPEUTIC PRODUCTS
V	Various

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

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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
Navinta Llc	FOMEPIZOLE	fomepizole	INJECTABLE;INJECTION	078537-001	Mar 6, 2008	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Am Regent	FOMEPIZOLE	fomepizole	INJECTABLE;INJECTION	078368-001	Dec 14, 2007	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Gland Pharma Ltd	FOMEPIZOLE	fomepizole	INJECTABLE;INJECTION	216791-001	Jul 6, 2023	AP	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Mylan Institutional	FOMEPIZOLE	fomepizole	INJECTABLE;INJECTION	079033-001	Apr 7, 2009		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
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 fomepizole

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Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2006115626		⤷ Sign Up
Mexico	2007013118	PROCESO PARA LA PREPARACION DE 4-METILPIRAZOL ULTRAPURO. (PROCESS FOR THE PREPARATION OF ULTRAPURE 4-METHYLPRAZOLE.)	⤷ Sign Up
Japan	2008538560		⤷ 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
>Country	>Patent Number	>Title	>Estimated Expiration

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