There are currently no generic versions of Zyflo CR (zileuton CR) available in the United States. All of the patents have expired, so it's unclear why this is the case. For your safety, do not buy anything claiming to be a "generic" version of Zyflo CR until an approved version is available.
Zyflo CR is made by Critical Therapeutics, Inc. At this time, there are no generic versions of Zyflo CR approved for sale in the United States.
When Will Generic Zyflo CR Be Available?
All the listed patents for Zyflo CR expired in December 2010, June 2012, and September 2013. Yet, no generic versions are available, for unclear reasons.
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 from a generic version of a medicine. In order for there to be a generic version, the original medicine must have gone off patent and another company besides the original manufacturer must make the product.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Food and Drug Administration, Center for Drug Evaluation and Research. Electronic orange book: approved drug products with therapeutic equivalence evaluations. FDA Web site. Available at: http://www.fda.gov/cder/ob/. Accessed December 3, 2013.
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