Teva Granted Final Approval of Risperidone ANDA; Launches with 180-Day Exclusivity

Jul. 2.08 | About: Teva Pharmaceutical (TEVA)

On Monday, Teva (NYSE:TEVA) announced that the FDA granted final approval to its ANDA for generic Risperdal (risperidone) tablets.  It also announced that it was awarded 180-day exclusivity as the first paragraph IV filer for risperidone, and that it immediately commenced a commercial launch.  The FDA confirmed the final approval in a press release.  Risperdal is a schizophrenia drug marketed by Janssen, a unit of Johnson & Johnson (NYSE:JNJ), with annual U.S. sales of $2.8 billion.

FDA's decision to grant 180-day exclusivity to Teva follows an April 11, 2008, order of the U.S. District Court for the District of Columbia, granting Teva's request to require FDA to relist Janssen's U.S. Patent No. 5,158,952 in the Orange Book and enjoin FDA from approving any other risperidone ANDAs until Teva's 180-day exclusivity period expires.

Teva was the first ANDA applicant to file a paragraph IV certification on the '952 patent, but FDA delisted the patent in 2001, in response to a request from Janssen.  FDA argued to the district court that the '952 patent was delisted before Teva filed its ANDA.  Teva argued that the delisting "did not become effective until January 2002, when the official Orange Book reflected the delisting of that patent."

FDA has appealed the district court's decision to the U.S. Court of Appeals for the D.C. Circuit, and oral argument is scheduled for September 12, 2008.  Meanwhile, according to the FDA website, risperidone ANDAs filed by Mylan (NASDAQ:MYL) and Pliva [a subsidiary of Barr Labs (BRL)] have tentative approval.  Thus, if the D.C. Circuit reverses the district court, Teva's 180-day exclusivity period would be cut short.