Exelixis announced that it has entered into a Settlement and License Agreement with Teva Pharmaceuticals Development, Inc. and Teva Pharmaceuticals USA, Inc. (collectively Teva). This settlement resolves patent litigation brought by Exelixis in response to Teva’s Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of CABOMETYX® (cabozantinib) tablets prior to the expiration of the applicable patents.
Pursuant to the terms of the agreement, Exelixis will grant Teva a license to market its generic version of CABOMETYX in the United States beginning on January 1, 2031, if approved by the U.S. Food and Drug Administration and subject to conditions and exceptions common to agreements of this type.
Additionally, in accordance with the Agreement, the parties will terminate all ongoing Hatch-Waxman litigation between Exelixis and Teva regarding CABOMETYX patents pending in the U.S. District Court for the District of Delaware.