A patent currently prohibits any generic Byetta from being manufactured and sold. However, there are companies claiming to sell a "generic Byetta," but be advised that these medications are fake, substandard, and potentially dangerous. The earliest date that a generic version of Byetta could become available is in 2016, when Byetta's first patent expires.
Generic for Byetta: An Overview
Byetta® (exenatide) is a prescription medication that has been licensed as a type 2 diabetes treatment. The drug is an incretin mimetic, which means that it mimics the actions of the incretin hormones in the body. As an incretin mimetic, Byetta increases insulin production in response to meals and decreases the amount of glucose (sugar) that the liver produces. Byetta also slows the emptying of food from the stomach, which decreases the amount of food that people eat.
Byetta is manufactured by Amylin Pharmaceuticals, Inc. It is currently under the protection of a patent that prevents any generic Byetta from being manufactured in the United States. Yet, if you search the Internet for "generic Byetta," you may find a number of companies selling it. The fact is that these medicines are fake, substandard, and potentially dangerous. There may be generic Byetta available from another country, but there is really no way of knowing if you are getting genuine Byetta or not. You should not buy any generic Byetta until there is an approved generic available.
When Will Generic Byetta Be Available?
The first patent for Byetta currently expires in December 2016. This is the earliest possible date that a generic version of Byetta could become available. However, there are other circumstances that could come up to extend the exclusivity period of Byetta beyond 2016. This could include things such as other patents for specific Byetta uses or lawsuits. Once Byetta goes off patent, there may be several companies that manufacture a generic Byetta drug.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Byetta [package insert]. San Diego, CA: Amylin Pharmaceuticals, Inc.;2009 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 September 15, 2011.
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