Endo’s Par subsidiary is unleashing sapropterin dihydrochloride tablets in a dosage strength of 100 mg, and powder for oral solution, in dosage strengths of 100 mg and 500 mg.
The product is the generic of BioMarin’s Kuvan.
Par's sapropterin dihydrochloride tablets and powder for oral solution are the generic version of Kuvan tablets and powder for oral solution. They are the first, and currently the only, generic versions available, according to the company.
"We are excited to launch sapropterin tablets and powder for oral solution, expanding our product portfolio into the cofactor therapeutic class. This new product offering will allow patients a more cost effective alternative than what is currently available in the market," said Domenic Ciarico, executive vice president and chief commercial officer Endo sterile and generics.
Kuvan tablet and powder for oral solution had a market value of approximately $489 million for the 12 months ended June 30, 2020, according to BioMarin.