At this time, companies are not allowed to make generic versions of Folotyn (pralatrexate), as this drug is protected by patents and exclusivity rights that have not yet expired. The earliest estimated date when a generic version might become available is after the first patent expires in July 2017. However, lawsuits, new patents, or other circumstances may change this date.
Can I Buy Generic Folotyn?
Folotyn® (pralatrexate) is a prescription medication approved to treat peripheral T-cell lymphoma, a cancer that begins in the blood cells of the immune system.
Folotyn is made by Allos Therapeutics, Inc. It is not available in generic form because it is currently protected from generic competition by patents and exclusivity rights that have not yet expired.
When Will a Generic Version Be Available?
The first patent for Folotyn is set to expire in July 2017, which is the earliest predictable date that a generic version could become available. However, this could change, depending on many factors, such as lawsuits or additional patents for new Folotyn uses. Once the drug goes off-patent, there may be several companies that manufacture a generic Folotyn product.
Is Pralatrexate a Generic Folotyn?
No -- pralatrexate is the active ingredient in Folotyn, 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. FDA approved drug products. FDA Web site. Available at: http://www.accessdata.fda.gov/scripts/cder/drugsatfda/. Accessed February 9, 2012.
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