At this time, Edarbi (azilsartan) is not available in generic form, despite the fact that the first patents for the drug has expired. Although azilsartan is considered the generic name for Edarbi, it is not a generic version of the drug.
Edarbi is made by Takeda Pharmaceuticals America, Inc. It is currently under the protection of a patent that prevents any generic Edarbi from being manufactured in the United States.
When Will a Generic Version Be Available?
The first patents for Edarbi expired in June 2012 and December 2013. Yet, no generics are available. This suggests that at least one later-expiring patent is still protecting the drug from generic competition. The next patent for Edarbi is set to expire in June 2014. 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. This could include such things as lawsuits or other patents for specific Edarbi uses. Once the patent expires, there may be several companies that manufacture a generic Edarbi drug.
Is Azilsartan a Generic Version of Edarbi?
No -- azilsartan is the active ingredient in Edarbi, 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.
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 February 7, 2014.
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