A patent and exclusivity rights currently prevent a generic Caprelsa (vandetanib) from being manufactured in the United States. The first patent is expected to expire in September 2017, 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 Caprelsa?
Caprelsa® (vandetanib) is a prescription medication used to treat a certain type of thyroid cancer. Specifically, Caprelsa is used for advanced medullary thyroid cancer that has spread to other areas of the body and cannot be removed by surgery.
This medication is made by IPR Pharmaceuticals, Inc., for AstraZeneca Pharmaceuticals LP. It is currently under the protection of a patent and exclusivity rights that prevent any generic Caprelsa from being made in the United States.
When Will a Generic Version Be Available?
The first patent for Caprelsa expires in September 2017. This is the earliest predictable date that a generic version could become available. However, other circumstances could come up to extend or shorten the exclusivity period, including such things as lawsuits or other patents for specific Caprelsa uses. Once the medication goes off-patent, several companies may choose to manufacture a generic version.
Is Vandetanib a Generic Caprelsa?
No -- vandetanib is the active ingredient in Caprelsa, but is 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):
Caprelsa [package insert]. Wilmington, DE: AstraZeneca Pharmaceuticals LP;2011 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 25, 2011.
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