At this time, there are patents in place that prevent a company from making a generic Tudorza (aclidinium) product. However, once the first patents expire in June 2016, companies may be allowed to make a generic version of the medication. However, this date could change if new patents or lawsuits are filed.
Tudorza is manufactured by Forest Pharmaceuticals, Inc. It is currently under the protection of patents that prevent any generic Tudorza from being manufactured in the United States.
When Will a Generic Version Be Available?
The first patents for Tudorza are set to expire in June 2016. 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 things such as other patents for new Tudorza uses or lawsuits.
Is Aclidinium a Generic Tudorza?
No -- aclidinium bromide is the active ingredient in Tudorza, 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 September 20, 2012.
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