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news.Teva Pharmaceutical Industries has filed a lawsuit against the FDA seeking 180-day exclusivity for the generic version of Janssen Pharmaceutical's Risperdal tablets.
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Teva argued that the FDA’s denial of Teva’s Citizen’s petition, seeking the relisting of US patent and restoration of Teva’s 180-day exclusivity for its pending abbreviated new drug application for risperidone tablets, was unlawful, as Teva disputes that the agency provided legal notice that the patent had been delisted prior to the company’s submission of a Paragraph IV certification to that patent.
Teva claims that it should have the generic market to itself for the first six months because it was the first generic drugmaker to approach the FDA.