Fomepizole Patent Expiration

Fomepizole was first introduced by Par Pharmaceutical Inc in its drug Antizol on Dec 4, 1997. 5 different companies have introduced drugs containing Fomepizole.


Fomepizole Patents

Given below is the list of patents protecting Fomepizole, along with the drug name that holds that patent and the company name owning that drug.

Drug Used in Drug Patent Number Drug Patent Title Drug Patent Expiry Drug Owner
Antizol US7553863 Ultrapure 4-methylpyrazole Jun 30, 2027 Par Pharm Inc


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Fomepizole Generics

Several generic applications have been filed for Fomepizole. The first generic version for Fomepizole was by American Regent Inc and was approved on Dec 14, 2007. And the latest generic version is by Gland Pharma Ltd and was approved on Jul 6, 2023.

Given below is the list of companies who have filed for Fomepizole generic.


1. GLAND PHARMA LTD

Gland Pharma Ltd has filed for 1 generic for Fomepizole. Given below are the details of the strengths of this generic introduced by Gland Pharma Ltd.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5GM/1.5ML (1GM/ML) injectable Prescription INJECTION AP Jul 6, 2023


2. NAVINTA LLC

Navinta Llc has filed for 1 generic for Fomepizole. Given below are the details of the strengths of this generic introduced by Navinta Llc.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5GM/1.5ML (1GM/ML) injectable Prescription INJECTION AP Mar 6, 2008


3. MYLAN INSTITUTIONAL

Mylan Institutional Llc has filed for 1 generic for Fomepizole. Given below are the details of the strengths of this generic introduced by Mylan Institutional.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5GM/1.5ML (1GM/ML) injectable Discontinued INJECTION N/A Apr 7, 2009


4. AM REGENT

American Regent Inc has filed for 1 generic for Fomepizole. Given below are the details of the strengths of this generic introduced by Am Regent.

Strength Dosage Form Availability Application Pathway TE code Launch Date
1.5GM/1.5ML (1GM/ML) injectable Prescription INJECTION AP Dec 14, 2007