A patent currently prevents any generic Vyvanse from being manufactured in the United States. The earliest date that a generic version of Vyvanse could be available is in June 2023, when the first patent protecting the medication expires. However, there are other circumstances that could come up to push that date past 2023, such as lawsuits or other patents for specific uses of Vyvanse.
Generic Vyvanse: An Overview
Vyvanse™ (lisdexamfetamine dimesylate) is a prescription medication that is approved for treating attention deficit hyperactivity disorder (ADHD) in adults, adolescents, and children age 6 to 12 years old. It belongs to a group of medications known as amphetamines.
Vyvanse is manufactured by Shire US. Vyvanse is currently protected by a patent that prevents any generic Vyvanse from being manufactured in the United States.
When Will There Be a Generic Vyvanse?
The first patent for Vyvanse currently expires in June 2023. This is the earliest date that a generic version of Vyvanse could become available. However, there are other circumstances that could come up to extend the exclusivity period of Vyvanse beyond 2023. This could include things such as other patents for specific Vyvanse uses or lawsuits. Once Vyvanse goes off patent, there may be several companies that manufacture a generic Vyvanse drug.
Is Lisdexamfetamine a Generic Vyvanse?
The answer is no. Lisdexamfetamine is the active ingredient in Vyvanse, but it is not a generic version of Vyvanse. What can be confusing is that, oftentimes, the active ingredient of a drug is referred to as the "generic name." The generic name is different than 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) would 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 July 13, 2007.
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