Four Generics of Shire’s ADHD Drug Intuniv Flood U.S. Market

June 15, 2015

Shire’s blockbuster attention deficit hyperactivity disorder drug Intuniv is facing competition as four generic versions of the therapy hit the U.S. market.

Sandoz, Mylan, Teva and Par Pharmaceuticals began launching copies of Intuniv (guanfacine hydrochloride) in extended-release 1 mg, 2 mg, 3 mg and 4 mg strength tablets following FDA approval of their ANDAs.

Shire’s patent for Intuniv doesn’t expire until September. However, an April 2013 patent litigation agreement with Actavis allowed the Irish drugmaker to launch a generic version of the drug in December 2014, with 180 days of marketing exclusivity. Now that the exclusivity period is over, other generics makers are free to sell their own versions.

According to IMS Health, U.S. sales for branded Intuniv totaled about $800 million for the fiscal year ending March 31. — Kellen Owings