Shire receives notice of patent challenge from Teva over its ADHD drug Intuniv

UK drugmaker Shire says that it has received a Paragraph IV Notice Letter from Israeli-owned Teva Pharmaceuticals USA advising that the latter had filed an Abbreviated New Drug Application with the US Food and Drug Administration for a generic version of Shire's attention deficit hyperactivity disorder (ADHD) drug Intuniv (guanfacine HCl). Extended release tablets 1mg, 2mg, 3mg, and 4mg.

Shire, now headquartered in Dublin, Ireland, for tax reasons, says that Intuniv is protected by three FDA Orange Book listed patents: US Patent No 5,854,290, Use of Guanfacine in the Treatment of Behavioral Disorders; US Patent No 6,287,599 ("the '599 patent") and US Patent No 6,811,794 ("the '794 patent") both titled Sustained Release Pharmaceutical Dosage Forms with Minimized pH Dependent Dissolution Profiles. The three patents expire in 2015, 2020 and 2022, respectfully, the firm pointed out.

Shire is currently reviewing the details of Teva's Paragraph IV Notice Letter which was only directed to the '599 and '794 patents.