BioMarin Pharmaceutical Inc announced that the United States Patent Office has issued patents covering stable tablet formulation and the approved once daily dosing regimen for Kuvan (sapropterin dihydrochloride) for the treatment of phenylketonuria (PKU). The patent for stable tablet formulation expires in 2025, and the patent for the once daily dosing regimen expires in 2024.

"We believe the issuance of these two patents is significant in strengthening our proprietary position on Kuvan," said Jean-Jacques Bienaime, chief executive officer of BioMarin. "These patents provide coverage for Kuvan's formulation and approved dosing regimen that extends approximately ten years beyond orphan drug protection and we believe will prevent therapeutically equivalent competition from entering the market."

Kuvan (sapropterin dihydrochloride) Tablets are indicated in the United States to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria (PKU).

PKU, a genetic disorder affecting approximately 50,000 diagnosed patients in the developed world, is caused by a deficiency of the enzyme phenylalanine hydroxylase.

BioMarin develops and commercializes innovative biopharmaceuticals for serious diseases and medical conditions.