Dr. Reddy’s Laboratories has launched a generic version of BioMarin Pharmaceuticals’ Kuvan for the treatment of adults and children with phenylketonuria (PKU) in the U.S.

This generic will be distributed in bottles of 120 tablets, each containing 100 mg of sapropterin dihydrochloride, Kuvan’s active ingredient.

“We are pleased to launch this generic version of sapropterin dihydrochloride tablets, for oral use, illustrating our continued commitment to bring affordable generic medicines to market for patients,” Marc Kikuchi, CEO of North America Generics at Dr. Reddy’s Laboratories, said in a press release.

“At the same time, this product demonstrates that we are actively expanding the breadth of our portfolio with a treatment for a rare disease. We are pleased to provide financial support to patients by offering a co-pay card program for eligible patients, details will be available on our website,” Kikuchi said.

Sapropterin dihydrochloride is an activator of phenylalanine hydroxylase (PAH), the enzyme that is missing in patients with PKU and is needed for the breakdown of the amino acid phenylalanine. (Amino acids are the building blocks of proteins.)

The medication is an artificial version of tetrahydrobiopterin (BH4), a PAH co-activator that normally binds and stimulates PAH to convert phenylalanine into another amino acid called tyrosine. By doing so, sapropterin dihydrochloride helps lower the levels of phenylalanine in the blood.

Importantly, the medication is meant to be used in combination with a phenylalanine-restricted diet, and not as an alternative.

Kuvan, the brand product that contains the same active ingredient, is one of the two approved therapies available to treat PKU patients in the U.S. The medication was approved by the U.S. Food and Drug Administration in 2007 for the treatment of adults and children 1 month and older.

Also developed and marketed by BioMarin, Palynziq (pegvaliase-pqpz) is the second therapy approved to treat adults with the disease. Unlike Kuvan, which is given orally, Palynziq is administered by a subcutaneous (under-the-skin) injection that can be performed at home.

Palynziq also in intended to lower the levels of phenylalanine in the blood, but does so in a different way. Instead of promoting the activity of PAH, it provides patients with an enzyme called pegvaliase that also can break down phenylalanine and act as a substitute for PAH. This form of therapy, known as an enzyme replacement therapy, was approved in the country in 2018.