Although the first patents for Gabitril (tiagabine hydrochloride) have expired, no generic versions are available at this time. However, the drug's next patent is set to expire in April 2016. 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.
Gabitril is manufactured by Cephalon, Inc. This epilepsy medication is currently under the protection of a patent that prevents any generic Gabitril from being manufactured in the United States.
When Will Generic Gabitril Be Available?
The first patents for Gabitril expired in September 2011 and March 2012, yet no generic versions are available. This suggests that later-expiring patents are still protecting the drug from generic competition. The next Gabitril patent will expire in April 2016.
At this point, this is the earliest possible date that a generic version of the drug could become available. However, circumstances could extend this exclusivity period beyond 2016. This could include such things as lawsuits or other patents for specific Gabitril uses. Once the patent expires, several companies will likely begin manufacturing generic Gabitril.
Is Tiagabine a Generic Gabitril?
No -- tiagabine is the active ingredient in Gabitril, but is not a generic version of it. What can be confusing is that, oftentimes, the active ingredient of any drug is 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 of a medicine, 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 April 10, 2012.
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