Although all of the patents for Nilandron (nilutamide) have expired, no company has chosen to make a generic version of the drug. It is unclear as to why a generic Nilandron product is not yet available or when a generic version might be manufactured. However, the demand for this medication is small, so making a generic product may not be profitable.
Can I Buy Generic Nilandron?
Nilandron® (nilutamide) is a prescription medication used after surgery in men with metastatic prostate cancer (prostate cancer that has spread to other areas of the body). The medication helps ease cancer symptoms, but is not a cure for prostate cancer. Nilandron belongs to a class of medications known as antiandrogens.
Nilandron is manufactured by sanofi-aventis U.S., LLC. It is no longer protected by patents. However, it is currently not available as a generic.
When Will a Generic Version Be Available?
No company currently makes a generic Nilandron medication. It is unclear why a generic version is not available at this time. The demand for this medication may be too small for it to be profitable to make a generic version. Because it is unknown why a generic version is not yet available, it is impossible to predict when, or if, a manufacturer will choose to make a generic Nilandron product.
Is Nilutamide a Generic Nilandron?
No -- nilutamide is the active ingredient in Nilandron, but it 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 of a medicine, 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 June 7, 2011.
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