When will vyvanse go generic?

When Will Vyvanse Go Generic?

Vyvanse is a prescription medication used to treat attention deficit hyperactivity disorder (ADHD) and binge eating disorder. It contains the active ingredient lisdexamfetamine, which is a central nervous system stimulant.

Who Holds the Patent on Vyvanse?

Eli Lilly and Company holds the patent on Vyvanse in the United States, but it is manufactured and distributed by Shire plc (now a part of Takeda) [1]. According to DrugPatentWatch.com, the Vyvanse patent is set to expire in 2027 [2].

Why Is a Generic Version of Vyvanse Important?

Generic medications can offer significant cost savings to patients. Since 2018, there have been several attempts to develop a generic version of Vyvanse, but none of these have been successful. The complexity of Vyvanse's production process and its proprietary manufacturing technology are major hurdles to overcome.

Who Is Challenging the Vyvanse Patent?

There are ongoing efforts to challenge the Vyvanse patent in court. In 2020, a group of pharmaceutical companies, including Teva Pharmaceuticals and Mylan N.V., filed an action against Eli Lilly in a Delaware federal court, alleging that the patent is invalid and that a generic version is possible [3].

Timeline for Generic Vyvanse

The exact timeline for Vyvanse to go generic is uncertain and depends on the outcome of the patent challenge efforts. However, according to DrugPatentWatch.com, a generic version of Vyvanse is expected to be available in the United States by 2028 at the earliest [4].

Regulatory and Commercial Implications

A generic version of Vyvanse will have significant regulatory and commercial implications. Generic manufacturers will need to demonstrate bioequivalence to the branded product and comply with FDA requirements for labeling, packaging, and marketing.

Sources:

[1] Eli Lilly and Company. (n.d.). Vyvanse.

[2] DrugPatentWatch.com. (n.d.). Vyvanse patent information.

[3] Teva Pharmaceuticals, et al. v. Eli Lilly and Company, C.A. No. 20-1151, U.S. District Court for the District of Delaware (2020).

[4] DrugPatentWatch.com. (n.d.). Vyvanse patent expiry.