US Patent and Trademark Office has allowed claims covering the approved administration of BioMarin’s Kuvan (sapropterin dihydrochloride) with food, based on the discovery that food increases the bioavailability of Kuvan. The company expects that the patent, which expires in 2024, will officially issue later this year.
Jean-Jacques Bienaime, chief executive officer of BioMarin, said: “This food effect patent, along with the patents issued for once daily dosing and stable tablet formulation, continues to strengthen our proprietary position on Kuvan and provides protection that extends approximately ten years beyond orphan drug exclusivity. We believe these patents will create significant barriers to therapeutically equivalent generic competition prior to their expiration.”
Kuvan tablets are indicated in the US to reduce blood phenylalanine (Phe) levels in patients with hyperphenylalaninemia (HPA) due to tetrahydrobiopterin- (BH4-) responsive phenylketonuria (PKU). Kuvan is to be used in conjunction with a Phe-restricted diet. The active ingredient in Kuvan, sapropterin dihydrochloride, is the synthetic form of 6R-BH4 (tetrahydrobiopterin), a naturally occurring enzyme cofactor that works in conjunction with phenylalanine hydroxylase (PAH) to metabolize Phe.
Kuvan has received orphan drug designation from both the FDA and the EMEA. Kuvan has received seven years of orphan exclusivity in the US and ten years of market exclusivity in the EU.