Exelixis Inc.

06/21/2021 | Press release | Distributed by Public on 06/21/2021 15:15

Material Event (Form 8-K)

Other Events.
In May 2021, Exelixis, Inc. ('Exelixis') received notice letters from Teva Pharmaceuticals USA, Inc. and Teva Pharmaceuticals Development, Inc. (collectively, 'Teva') regarding an Abbreviated New Drug Application ('ANDA') Teva submitted to the U.S. Food and Drug Administration('FDA'), requesting approval to market a generic version of CABOMETYX® tablets. Teva's notice letters included Paragraph IV certifications with respect to our U.S. Patent Nos. 9,724,342 (formulations), 10,034,873 (methods of treatment) and 10,039,757 (methods of treatment), which are listed in the Approved Drug Products with Therapeutic Equivalence Evaluations, also referred to as the Orange Book, and expire in 2033, 2031 and 2031, respectively. Teva's notice letters did not provide notice of a Paragraph IV certification against any additional CABOMETYX patents.
On June 17, 2021, Exelixis filed a complaint in the United States District Court for the District of Delaware for patent infringement against Teva, along with Teva Pharmaceutical Industries Limited, asserting U.S. Patent Nos. 9,724,342 (formulations), 10,034,873 (methods of treatment) and 10,039,757 (methods of treatment) arising from Teva's ANDA filing with the FDA. Exelixis is seeking, among other relief, an order that the effective date of any FDA approval of Teva's ANDA be no earlier than the expiration of all of U.S. Patent Nos. 9,724,342, 10,034,873 and 10,039,757, the latest of which expires on July 9, 2033,and equitable relief enjoining Teva from infringing these patents.