Exelixis, Inc. (EXEL) announced Monday that it has entered into a Settlement and License Agreement with Cipla Ltd. and Cipla USA, Inc. to resolve two patent litigations brought by Exelixis in response to Cipla's Abbreviated New Drug Application (ANDA) seeking approval to market generic versions of CABOMETYX (cabozantinib) tablets prior to the expiration of the applicable patents.
The first case, filed on March 16, 2023, relates to Cipla's ANDA for 60 mg cabozantinib dosage strength. The second case, filed on May 9, 2024, relates to a recent amendment to Cipla's ANDA, for the primary purpose of seeking additional approval for 20 mg and 40 mg cabozantinib dosage strengths.
Pursuant to the terms of the Agreement, Exelixis will grant Cipla a license to market generic versions 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 Cipla regarding CABOMETYX patents pending in the U.S. District Court for the District of Delaware.
The agreement is confidential and subject to review by the U.S. Federal Trade Commission (FTC) and the U.S. Department of Justice. The lawsuits will be dismissed after a period of time to allow for FTC review.
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