US appeals court upholds Shire’s patents for Vyvanse drug

Mylan, Amneal Pharmaceuticals, Roxane Laboratories, Actavis and Sandoz had filed abbreviated new drug applications (ANDAs) to market generic versions of Vyvanse.

Following the drug makers’ plan to create generic versions of the drug, Shire filed several lawsuits in 2011 and 2012.

In its latest decision, the Court of Appeals of the Federal Circuit affirmed the District Court’s summary judgment ruling that 18 patent claims from four of the FDA Orange Book-listed patents for Vyvanse are valid.

The patent claims cover Vyvanse’s active ingredient, the lisdexamfetamine dimesylate compound, and a method of using lisdexamfetamine dimesylate for the treatment of ADHD.

Shire interim general counsel Mark Enyedy said: "We are extremely pleased that the Federal Circuit affirmed the District Court’s ruling that the patents are valid, which further confirms that Shire has strong patents protecting Vyvanse."

Earlier this year, the US Food and Drug Administration approved Vyvanse (lisdexamfetamine dimesylate) Capsules (CII) to treat binge-eating disorder (B.E.D.) in adults.

Vyvanse is indicated for ADHD in patients 6 years and above, and for moderate to severe B.E.D. in adults.

Shire said Vyvanse is a federally controlled substance as it can be abused or lead to dependence.

ADHD may be caused in part by an imbalance in chemical messengers that affect behavior. The types of ADHD include predominantly inattentive, predominantly hyperactive/impulsive, and combined type.