Court grants Teva generic Risperdal exclusivity
NEW YORK (Reuters) - Teva Pharmaceutical Industries Ltd (TEVA.O) said on Friday a U.S. court granted a request that would give the Israeli company 180 days of exclusivity selling a generic version of widely used schizophrenia drug Risperdal.
Johnson & Johnson's (JNJ.N) Risperdal, which is also approved to treat bipolar mania, had U.S. sales of about $2.5 billion in 2007.
Teva, whose shares were up 1.4 percent, expects final approval with exclusivity on June 29.
The exclusivity period is critically important to generic drugmakers' profits as prices typically plunge once other companies start selling their versions of a medicine.
"We project Teva could record around $230 million (in sales) during its exclusivity period," JPMorgan analyst Adam Greene said in a research note, adding that there had been low expectations for a Teva victory in court.
But he cautioned, "generic Risperdal will be a short-lived asset as we expect the market to be very competitive on day 181."
Teva said the U.S. District Court for the District of Columbia granted the request to have the U.S. Food and Drug Administration relist the Risperdal patent in its so-called Orange Book for the purposes of establishing the exclusivity period.
Teva first sought U.S. approval for a version of tablet forms of Risperdal in 2001. It argued it should have the generic market to itself for the first six months as the first to approach the FDA seeking to sell the drug known generically as risperidone.
The first company to file for approval of a generic is usually granted the exclusivity period.
At the time Teva notified the FDA it planned to officially challenge J&J's main Risperdal patent.
Because the FDA later in 2001 informed Teva it had removed Risperdal from its Orange Book of registered patents, it was expected the agency would likely allow all approved generics to launch their products once the patent expires in June.
In its lawsuit, Teva contended the FDA failed to provide legal notice that it was removing the Risperdal patent prior to Teva's challenge.
Teva shares were up 63 cents at $46.75 in late Nasdaq trade.
(Reporting by Bill Berkrot; Editing by Andre Grenon and Braden Reddall)
