BioMarin Pharmaceutical has announced that it has entered into a settlement agreement with Dr Reddy's Laboratories (Dr Reddy's) that resolves patent litigation in the United States (US) related to BioMarin's Kuvan (sapropterin dihydrochloride) 100mg oral tablets.

Under the terms of the settlement, BioMarin will grant Dr Reddy's a non-exclusive license to its patents related to Kuvan to allow the company to market a generic version of sapropterin dihydrochloride 100mg tablets in the US for the indications approved for Kuvan beginning at a confidential date in the future, but which is more than five years from today, or earlier under certain circumstances. Additional details of the agreement remain confidential.

"This settlement agreement recognizes the strength of the intellectual property related to Kuvan and helps to ensure that patients who depend on Kuvan to manage their phenylketonuria (PKU) will continue to receive the medication and the range of support services offered to patients for years to come," said Mr Jeff Ajer, executive vice-president and chief commercial officer of BioMarin. "This settlement is beneficial to patients, clinicians, BioMarin and our shareholders, as it removes the cost, distraction nd uncertainty associated with this litigation."

BioMarin continues to vigorously enforce its intellectual property related to Kuvan. This includes continuing its suit against Par Pharmaceutical which is not affected by this settlement. As required by law, BioMarin and Dr Reddy will submit the Agreement to the US Federal Trade Commission and the US.