Brand-name Tarceva (erlotinib) is currently protected from generic competition. The first patent for the drug is set to expire in November 2018; this would be the earliest predictable date a generic version could become available, provided there are no lawsuits or other circumstances to extend or shorten the exclusivity period.
Tarceva is made Schwarz Pharma Manufacturing for OSI Pharmaceuticals, Inc. It is distributed by Genentech USA, Inc. It is currently under the protection of patents and exclusivity rights that prevent any generic Tarceva from being manufactured in the United States.
When Will a Generic Version Be Available?
The first patent for Tarceva will expire in November 2018. 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, such as lawsuits or other patents for specific Tarceva uses. Once the patent expires, several companies may start manufacturing a generic Tarceva drug.
Is Erlotinib a Generic Tarceva?
No, erlotinib is the active ingredient in Tarceva, but is not a generic version of it. What can be confusing is that, oftentimes, the active ingredient of any 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, 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):
Tarceva [package insert]. Farmingdale, NY: OSI Pharmaceuticals, LLC;2013 May.
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 22, 2011.
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