At this time, there is no generic lisdexamfetamine available in the United States because the drug is protected by a patent. The earliest date that a generic version of the drug could become available is when the patent expires in June 2023. However, this date could be pushed back even further due to lawsuits or other patents for specific uses of lisdexamfetamine.
Generic Lisdexamfetamine: An Overview
Lisdexamfetamine dimesylate (Vyvanse™) is a prescription medication that is approved for treating attention deficit hyperactivity disorder (ADHD) in children age 6 to 12 years old, adolescents, and adults. It belongs to a group of medications known as amphetamines.
Lisdexamfetamine is manufactured by Shire US. Lisdexamfetamine is currently protected by a patent that prevents any generic lisdexamfetamine from being manufactured in the United States.
When Will There Be a Generic Lisdexamfetamine?
The first patent for lisdexamfetamine currently expires in June 2023. This is the earliest date that a generic version of lisdexamfetamine could become available. However, there are other circumstances that could come up to extend the exclusivity period of lisdexamfetamine beyond 2023. This could include things such as other patents for specific lisdexamfetamine uses or lawsuits. Once lisdexamfetamine goes off patent, there may be several companies that manufacture a generic lisdexamfetamine drug.
Is Lisdexamfetamine a Generic Lisdexamfetamine?
No, it isn't. 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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