A patent and exclusivity rights currently prevent a generic SUTENT (sunitinib) from being manufactured in the United States. The first patent is expected to expire in February 2021, 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.
Can I Buy Generic SUTENT?
SUTENT® (sunitinib) is a prescription medication approved for the treatment of certain types of cancer. It belongs to a group of medicines called tyrosine kinase inhibitors. This medication helps slow the growth of cancer cells.
SUTENT is made by Pfizer Italia S.r.l. and distributed by Pfizer Labs. It is currently under the protection of a patent and exclusivity rights that prevent any generic SUTENT from being manufactured in the United States.
When Will Generic SUTENT Be Available?
The first patent for SUTENT currently expires in February 2021. 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 includes such things as lawsuits or other patents for specific SUTENT uses. Once the patent expires, there may be several companies that manufacture a generic SUTENT drug.
Is Sunitinib a Generic SUTENT?
No, sunitinib is the active ingredient in SUTENT, not a generic version of it. What can be confusing is that the active ingredient of any 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
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
SUTENT [package insert]. Research Triangle Park, NC: GlaxoSmithKline;2010 April.
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 9, 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