Patents and exclusivity rights currently prevent a generic Sprycel (dasatinib) from being manufactured in the United States. The first patent is expected to expire in April 2020, which would be the earliest date that a generic version might become available. However, certain circumstances, such as lawsuits or other patents for new uses of the drug, could delay this date.
Sprycel is made by Bristol-Myers Squibb Company. 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 is set to expire in April 2020. This is the earliest predictable date that a generic version could become available.
However, other circumstances could come up to extend or shorten this exclusivity period. This could include such things as lawsuits or other patents for specific Sprycel uses. Once the drug goes off-patent, there may be several companies that manufacture a generic Sprycel drug.
Is Dasatinib a Generic Sprycel?
Dasatinib is the active ingredient in Sprycel, 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 October 14, 2011.
eMedTV serves only as an informational resource. This site does not dispense medical advice or advice of any kind.
Site users seeking medical advice about their specific situation should consult with their own physician. Click