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Last Updated: October 21, 2021

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FOMEPIZOLE - Generic Drug Details

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What are the generic sources for fomepizole and what is the scope of patent protection?

Fomepizole is the generic ingredient in two branded drugs marketed by Par Pharm Inc, Am Regent, Mylan Institutional, and Navinta Llc, and is included in five 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. Four suppliers are listed for this compound.

Summary for FOMEPIZOLE
Drug Prices for FOMEPIZOLE

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Recent Clinical Trials for FOMEPIZOLE

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

SponsorPhase
University of ArizonaPhase 4
TakedaN/A
Ted Daley, PresidentPhase 1/Phase 2

See all FOMEPIZOLE clinical trials

Pharmacology for FOMEPIZOLE
Drug ClassAntidote

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
Mylan Institutional FOMEPIZOLE fomepizole INJECTABLE;INJECTION 079033-001 Apr 7, 2009 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Am Regent FOMEPIZOLE fomepizole INJECTABLE;INJECTION 078368-001 Dec 14, 2007 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Par Pharm Inc ANTIZOL fomepizole INJECTABLE;INJECTION 020696-001 Dec 4, 1997 DISCN Yes No ⤷  Try it Free ⤷  Try it Free Y Y ⤷  Try it Free
Navinta Llc FOMEPIZOLE fomepizole INJECTABLE;INJECTION 078537-001 Mar 6, 2008 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Mylan Institutional FOMEPIZOLE fomepizole INJECTABLE;INJECTION 078639-001 Mar 3, 2008 AP RX No Yes ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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Serving leading biopharmaceutical companies globally:

Moodys
Merck
Mallinckrodt
Harvard Business School
Johnson and Johnson
Colorcon

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