USPTO Grants Patent Covering Approved Administration Of Kuvan With Food

The US Patent and Trademark Office (USPTO) has issued a patent to BioMarin Pharmaceutical (BioMarin) covering the approved administration of Kuvan (sapropterin dihydrochloride) with food for the treatment of phenylketonuria (PKU). The patent expires in 2024.

Kuvan (sapropterin dihydrochloride) 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.

Jean-Jacques Bienaime, CEO of BioMarin, said: “We believe that the food effect patent, based on the discovery that food increases the bioavailability of Kuvan, along with our patents for once daily dosing and stable tablet formulation, will create significant barriers to therapeutically equivalent generic competition from entering the market for approximately ten years beyond orphan drug exclusivity.

“We remain committed to serving the PKU community with initiatives such as implementation of an outcomes study in the second quarter of next year and the ongoing development of a blood Phe monitor. We also look forward to results from various investigator-sponsored trials that, if positive, will strengthen the value proposition for the use of Kuvan.”