BioMarin Pharmaceutical said it entered into a settlement agreement with Par Pharmaceutical that resolves patent litigation in the United States related to BioMarin’s Kuvan (sapropterin dihydrochloride) 100mg oral tablets and powder for oral solution in 100mg packets.
Kuvan is a drug used to treat people with the rare genetic disorder PKU.
BioMarin said it 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 US for the indications approved for Kuvan beginning October 1, 2020 or earlier under certain circumstances.
Additional details of the agreement remain confidential.
BioMarin said it holds patents in Europe related to Kuvan that are valid until at least 2024.
BioMarin and Par will submit the agreement to the US Federal Trade Commission and the US Department of Justice.