Teva files lawsuit against FDA for generic Risperdal exclusivity

WASHINGTON Teva Pharmaceutical Industries announced that it filed a lawsuit against the Food and Drug Administration to seek an order for the FDA to grant the company an 180-day exclusivity for its generic version of Risperdal.

Risperdal is used for the treatment of schizophrenia and, according to published reports, shows annual sales of $3.5 billion. Teva is ordering through the lawsuit that the FDA re-list in the Orange Book US Patent No. 5,158,952, in which it submitted its generic version known as risperidone in 2001.

The denial of Teva’s Citizen’s Petition to re-list the patent by the FDA was seen as unlawful by Teva, and since it was the first to challenge the patent for the drug in 2001, the company felt that it should inherit the 180-day exclusivity period for its genetic version. However, the FDA disputes that since it removed the patent from the orange book in 2001, the submission also fell, and, in effect, its request was not valid.