Although the first patents for rosiglitazone and glimepiride (Avandaryl) have expired, no generic versions are available at this time. However, the drug's next patent is set to expire in October 2015. It's possible that a generic version could be introduced after this date, barring any lawsuits or other patents for specific uses of the drug.
Generic Rosiglitazone and Glimepiride: An Overview
In September 2010, the U.S. Food and Drug Administration (FDA) announced that it was severely restricting the use of rosiglitazone and glimepiride, due to the risk of "cardiovascular events" such as heart attacks and strokes. Only individuals who could not control their diabetes on other medications (or those who were already taking the medication and doing well) would be able to take rosiglitazone and glimepiride.
However, in November 2013, the FDA announced that a careful analysis of the research suggests that there is not, in fact, any increased risk, compared to treatment with standard diabetes medications and that the use of this medication will no longer be restricted.
Rosiglitazone and glimepiride is manufactured by GlaxoSmithKline. It is currently under the protection of a patent that prevents any generic versions from being manufactured in the United States. Yet, if you search the Internet for "generic rosiglitazone and glimepiride," 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 rosiglitazone and glimepiride available from another country, but there is really no way of knowing if you are getting the genuine drug or not. You should not buy any generic rosiglitazone and glimepiride until there is an approved generic available.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Last reviewed by: KristiMonson, PharmD;
List of references (click here):
Avandaryl [package insert]. Research Triangle Park, NC: GlaxoSmithKline;2011 February.
Food and Drug Administration, Center for Drug Evaluation and Research. FDA Drug Safety Communication: FDA requires removal of some prescribing and dispensing restrictions for rosiglitazone-containing diabetes medicines (November 25, 2013). FDA Web site. Available at: http://www.fda.gov/Drugs/DrugSafety/ucm376389.htm. Accessed December 20, 2013.
Food and Drug Administration, Center for Drug Evaluation and Research. Avandia (rosiglitazone): REMS - risk of cardiovascular events (9/23/2010). FDA Web site. Available at: http://www.fda.gov/Safety/MedWatch/SafetyInformation/SafetyAlertsforHumanMedicalProducts/ucm226994.htm. Accessed October 1, 2010.
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 April 10, 2012.
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