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NEW YORK, March 4 (Reuters) - Teva Pharmaceutical Industries Ltd TEVA.OTEVA.TA said on Tuesday it filed a lawsuit against the U.S. Food and Drug Administration seeking 180-day exclusivity for the Israeli company's generic form of Johnson and Johnson's JNJ.N Risperdal schizophrenia drug.
Risperdal, which has global annual sales of about $3.5 billion, is expected to lose its U.S. patent protection in late June and face immediate competition from one or more generic drugmakers.
Teva, which in 2001 sought U.S. approval for its copycat tablet forms of Risperdal, claims it should have the generic market to itself for the first six months because it was the first generic drugmaker to approach the FDA.
In seeking approval for its product at the time, Teva notified the FDA that it planned to officially challenge J&J’s main Risperdal patent.
But because the FDA later in 2001 informed Teva it had removed Risperdal from its Orange Book of registered patents, analysts have said the agency will likely allow all approved generics to launch their products in June.
Teva said on Tuesday its lawsuit asks for a relisting of the patent, contending the FDA failed to provide legal notice it was removing the Risperdal patent prior to Teva’s challenge. (Reporting by Ransdell Pierson; additional reporting by Varsha Tickoo in Bangalore; editing by Andre Grenon)
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