BioMarin Announces Kuvan Patent Challenge Settlement

BioMarin Pharmaceutical Inc. announced it has entered into a settlement agreement with Par Pharmaceutical that resolves patent litigation in the United States (U.S.) related to BioMarin's Kuvan (sapropterin dihydrochloride) 100mg oral tablets and powder for oral solution in 100mg packets.

Under the terms of the settlement, BioMarin will grant Par a non-exclusive license to its patents related to Kuvan to allow Par to market a generic version of sapropterin dihydrochloride 100mg tablets and powder for oral solution in 100mg and 500 mg sachets in the U.S. for the indications approved for Kuvan beginning October 1, 2020 or earlier under certain circumstances. Additional details of the agreement remain confidential.

BioMarin continues to vigorously enforce its intellectual property related to Kuvan. BioMarin holds patents in Europe related to Kuvan that are valid until at least 2024.

As required by law, BioMarin and Par will submit the Agreement to the U.S. Federal Trade Commission and the U.S. Department of Justice.