When will generic Intuniv (guanfacine ER) become available? The expected date is December 2014. The first patent for Intuniv actually expires in September 2015, but this earlier introduction of a generic version is due to the result of a legal settlement between Actavis and the manufacturer of Intuniv.
Intuniv is made by Shire Pharmaceuticals, Inc. It is currently under the protection of a patent that prevents any generic versions from being manufactured in the United States.
When Will a Generic Version of Intuniv Be Available?
The first patent for Intuniv currently expires in September 2015. However, a generic version is expected earlier, in December 2014, as the result of a settlement agreement between Shire (the manufacturer of Intuniv) and Actavis (a generic manufacturer). This is the earliest predictable date that a generic version of Intuniv could become available.
However, other circumstances could come up to extend or shorten this exclusivity period. This could include such things as lawsuits, settlements, or patents for other Intuniv uses.
Is Guanfacine ER a Generic Intuniv?
No -- guanfacine ER is the active ingredient in Intuniv, 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.
Short-acting guanfacine (Tenex®) is not the same as Intuniv and is not approved to treat ADHD.
Written by/reviewed by: Kristi Monson, PharmD;Arthur Schoenstadt, MD
Drug Store News. Actavis to launch generic ADHD drug in December 2014 (April 25, 2013). DSN Web site. Available at: http://drugstorenews.com/article/actavis-launch-generic-adhd-drug-december-2014. Accessed August 1, 2013.
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 October 30, 2009.
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