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Msg  29736 of 30257  at  3/22/2023 6:07:31 PM  by

Pacific


Form 8-K Cipla

https://www.sec.gov/ix?doc=/Archives/edgar/data/939767/000093976723000035/exel-20230316.htm

Item 8.01 Other Events

On March 16, 2023, Exelixis, Inc. (Exelixis) filed a complaint in the United States District Court for the District of Delaware against Cipla, Ltd. and Cipla USA, Inc. (individually and collectively referred to as Cipla), asserting infringement of U.S. Patents No. 8,877,776, 11,091,439, 11,091,440, 11,098,015 and 11,298,349 arising from Cipla’s filing of an Abbreviated New Drug Application (ANDA) with the U.S. Food and Drug Administration (FDA) for a generic version of CABOMETYX® (cabozantinib) tablets (20 mg / 40 mg / 60 mg). Cipla requests approval to market a generic version of CABOMETYX® tablets prior to expiration of U.S. Patents No. 8,877,776, 11,091,439, 11,091,440, 11,098,015 and 11,298,349. Exelixis is seeking, among other remedies, equitable relief enjoining Cipla from infringing these patents, as well as an order that the effective date of any FDA approval of Cipla’s ANDA would be a date no earlier than the expiration of the patents identified in the complaint, the latest of which expires on February 10, 2032. Cipla has not challenged U.S. Patent No. 7,759,473, which includes claims directed to the compound cabozantinib or a pharmaceutically acceptable salt thereof, and expires on August 14, 2026.


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