Although it is possible for a company to make a generic CeeNU (lomustine) product, no manufacturers have chosen to do so at this time. There are no longer any patents preventing this; however, it may not be profitable for a company to make a generic version because the demand for the drug may be too small.
CeeNU is made by Bristol-Myers Squibb Company. This medication was approved by the U.S. Food and Drug Administration (FDA) prior to 1982, making it an older medication. Although it is no longer protected by patents that would prevent generic competition in the United States, CeeNU is not available in generic form.
When Will a Generic Version Be Available?
As mentioned earlier, CeeNU is not protected by patents. Therefore, a manufacturer could make a generic version of it. However, at this time, no manufacturer has chosen to do so.
It is not entirely clear why a generic version of this drug is not being made. It could be that the demand for the medicine is too small for a manufacturer to profit from making a generic version. Because it is unclear why a manufacturer has not chosen to make generic form of CeeNU, it is difficult to predict when, or even if, a generic version will become available.
Is Lomustine a Generic CeeNU?
No -- lomustine is the active ingredient in CeeNU, but is not a generic version of it. What can be confusing is that the active ingredient of a drug is often 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 August 9, 2012.
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