There are currently no generic Cycloset products available on the market. Although there are other generic bromocriptine products available at this time, these are not equivalent to Cycloset. The first patent for Cycloset has already expired, so it's very likely that other patents continue to protect the drug from generic competition.
Generic Cycloset: An Overview
Cycloset™ (bromocriptine mesylate) is a prescription medication approved to treat type 2 diabetes. It belongs to a group of medications known as ergot alkaloids or dopamine agonists.
Brand-name Cycloset is manufactured by Patheon, Inc. for VeroScience LLC. This medication is protected by patents that prevent any generic versions from being sold in the United States.
When Will a Generic Form of Cycloset Be Available?
The first patent for Cycloset expired in November 2012, yet no generic versions became available. This strongly suggests that other patents, set to expire later, are still providing protection against generic competition. The next Cycloset patent is currently set to expire in October 2014. This is the earliest predictable date that a generic version could become available.
However, there are other circumstances that could come up to extend or shorten the exclusivity period of Cycloset (this could include such things as lawsuits or other patents for specific Cycloset uses). Once Cycloset goes off patent, there may be several companies that will manufacture a generic Cycloset drug.
Is Bromocriptine a Generic Cycloset?
The answer is no. Bromocriptine is the active ingredient in Cycloset but is not a generic version of the drug. Confusingly, bromocriptine has been available as a generic medication for a very long time, but generic bromocriptine is not equivalent to Cycloset. Generic bromocriptine is equivalent to Parlodel®, a medication that is available in different strengths and approved for different uses.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
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 January 24, 2013.
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