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



Fomepizole's Family Patents

Family Patents

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Fomepizole Generic API Manufacturers

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, along with the locations of their manufacturing plants worldwide.


1. 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





2. 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





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


Manufacturing Plant Locations
New

Mylan Institutional's manufacturing plants are situated in 1 country - United States. Given below are the details of these plant locations as well as the firm names of Mylan Institutional as present at those locations.

Country City Firm Name
United States
Rockford Mylan Institutional, Inc.





4. 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