Expects to be only generic entitled to 180-day exclusivity period.
Natco Pharma announced that its marketing partner in the USA, Breckenridge Pharmaceutical, Inc. (BPI), has filed an Abbreviated New Drug Application (ANDA) for Everolimus 0.25mg, 0.5mg, and 0.75mg Tablets.Natco and BPI believe that its Paragraph IV ANDA was filed on the First-to-File date and expects to be the only generic that is entitled to the 180-day exclusivity period.
Novartis AG sells Everolimus 0.25mg, 0.5mg, and 0.75mg Tablets under Brand name Zortress in the USA market. Zortress is used to prevent organ rejection after a kidney or liver transplant. Zortress generated sales of $43.5 million for the twelve-month period ending July 2014, based on industry sales data.
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