At this time, companies are not allowed to make a generic Bydureon (extended-release exenatide) product, as the drug is protected by patents. The first patent is set to expire in December 2016 -- this would be the earliest predictable date that a generic version could become available. However, many circumstances could affect when generic versions are actually allowed.
Bydureon is manufactured by Amylin Pharmaceuticals, Inc. Because this drug is protected by patents that have not yet expired, there are no generic versions of Bydureon available in the United States.
When Will a Generic Version Be Available?
Bydureon is expected to be protected from generic competition until at least December 2016, when the first patent is set to expire. This is the earliest predictable date that a generic version could become available.
However, other circumstances could come up to delay or shorten the exclusivity period. This could include such things as lawsuits or patents for new Bydureon uses. In fact, since December 2016 is actually listed for the short-acting version (Byetta®) as well, it is likely that other, later-expiring patents will protect Bydureon beyond 2016, although this is difficult to predict with certainty.
Is Exenatide a Generic Bydureon?
No -- exenatide is the active ingredient in Bydureon, but is not a generic version of it. What can be confusing is that the active ingredient of a 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.
Byetta® contains a short-acting version of Bydureon and is injected twice daily. It is not a generic version of Bydureon.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Bydureon [package insert]. San Diego, CA: Amylin Pharmaceuticals, Inc.;2012 January.
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 March 16, 2012.
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