Generic Zyflo CR

A patent currently prevents any generic Zyflo CR from being manufactured in the United States. The earliest date that a generic version of Zyflo CR could become available is in December 2010, when the patent expires. However, certain circumstances (such as lawsuits or other patents for specific uses of Zyflo CR) could potentially extend that date beyond 2010.

 

Generic Zyflo CR: An Overview

Zyflo CR™ (zileuton CR) is a prescription medication used to prevent asthma attacks. It belongs to a class of asthma medications called leukotriene synthesis inhibitors.
 
Zyflo CR is made by Critical Therapeutics, Inc. It is currently under the protection of a patent that prevents any generic Zyflo CR from being manufactured in the United States.
 

When Will Generic Zyflo CR Be Available?

The first patent for Zyflo CR is set to expire in December 2010. This is the earliest possible date that a generic version of Zyflo CR could become available. However, there are circumstances that could come up to extend the exclusivity period of Zyflo CR beyond 2010. This could include things such as other patents for specific Zyflo CR uses or lawsuits. Once Zyflo CR goes off patent, there may be several companies that manufacture a generic Zyflo CR product.
 

Is Zileuton a Generic Zyflo CR?

No -- zileuton is the active ingredient in Zyflo CR (and also in short-acting Zyflo), but it is not a generic version of Zyflo CR. What can be confusing is that, oftentimes, the active ingredient of a drug is referred to as the "generic name." The generic name is different than a generic version of a medicine. In order for there to be a generic version of a medicine, the original medicine must have gone off patent and another company (besides the original manufacturer) would make the product.
 
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Written by/reviewed by: Kristi Monson, PharmD; Arthur Schoenstadt, MD
Last reviewed by: Kristi Monson, PharmD;