There is currently a patent in place that prevents any generic Tykerb products from being manufactured in the United States. When the patent expires in July 2017, a number of drug companies may begin manufacturing a generic version of the medicine. However, circumstances could arise to delay the production of generic Tykerb, such as lawsuits or other patents for specific Tykerb uses.
Tykerb is manufactured by GlaxoSmithKline. It is currently under the protection of a patent that prevents any generic Tykerb from being manufactured in the United States.
When Will Generic Tykerb Be Available?
Pfizer holds the exclusive rights to market Tykerb until at least July 2017. This is the earliest possible date that a generic version of the drug could become available. However, circumstances could extend this exclusivity period beyond 2017. This could include such things as other patents for specific Tykerb uses or lawsuits. Once the patent expires, several companies could begin to manufacture a generic version of Tykerb.
Is Lapatinib a Generic Tykerb?
No -- lapatinib is the active ingredient in Tykerb, but is not a generic version of it. What can be confusing is that oftentimes, the active ingredient of a drug is 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
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Tykerb [package insert]. Research Triangle Park, NC: GlaxoSmithKline;2013 October.
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 July 18, 2007.
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