BioMarin Pharmaceutical Inc. recently agreed to a settlement with Par Pharmaceuticals surrounding Kuvan (sapropterin dihydrochloride) in which BioMarin will retain exclusive rights to the drug until Oct. 1, 2020.
BioMarin maintained its continued enforcement of its intellectual property for the drug in 100 mg oral tablets and powder for oral solution in 100 mg packets, according to a press release. The company’s European patents for the drug will remain valid until 2024.
Through the settlement, Par will receive a non-exclusive license to BioMarin’s patents on Kuvan on Oct. 1, 2020, but details of the agreement that are being kept confidential could potentially lead to an earlier date. Using the license, Par will be able to market a generic sapropterin dihydrochloride drug in 100 mg tablets and powder for oral solution in 100 mg and 500 mg sachets in the United States.
The agreement between the two companies is subject to approval with the U.S. Federal Trade Commission and the U.S. Department of Justice.