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Last Updated: November 2, 2024

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
Drug Prices for fomepizole

See drug prices for fomepizole

Recent Clinical Trials for fomepizole

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

SponsorPhase
Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare DivisionPhase 2
Richard Dart, MD, PhDPhase 2
University of ArizonaEarly Phase 1

See all fomepizole clinical trials

Pharmacology for fomepizole
Drug ClassAntidote
Anatomical Therapeutic Chemical (ATC) Classes for fomepizole
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

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Am Regent FOMEPIZOLE fomepizole INJECTABLE;INJECTION 078368-001 Dec 14, 2007 AP RX No No ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
Navinta Llc FOMEPIZOLE fomepizole INJECTABLE;INJECTION 078537-001 Mar 6, 2008 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
>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

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
>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.