Lisdexamfetamine dimesylate – USA

Lisdexamfetamine dimesylate – USA

On August 30, 2016, U.S. District Court for the District of New Jersey entered a Final Judgment ending a Hatch-Waxman patent infringement lawsuit and protecting innovator pharmaceutical company Shire’s blockbuster drug Vyvanse┬« (lisdexamfetamine dimesylate), which had net sales of over $1.7 billion in 2015.

The Final Judgment follows one of the few instances in a pharmaceutical case where the Federal Circuit has issued an opinion affirming summary judgment of no invalidity. The Federal Circuit here affirmed the District Court, which also found that the claims are infringed and not invalid for anticipation. The ANDA-filers were Actavis, Amneal, Mylan, Roxane, and Sandoz.

The Final Judgment includes injunctions preventing the ANDA-filers from launching generic versions of Vyvanse® until the full term the patents, which expire in 2023.

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