Endo’s Par Pharmaceutical has kicked off generic competition on a new product in the US after confirming market entry for “the first, and currently the only,” generics to BioMarin’s Kuvan (sapropterin dihydrochloride), in both 100mg tablet formulation and 100mg and 500mg powder for oral solution, before Dr. Reddy's Laboratories Ltd. followed suit on the tablet formulation a little over 24 hours later.
Updated: Reddy's Follows Endo On US Kuvan Launch
Sapropterin Market Worth Roughly $500m
Under the terms of a patent-litigation settlement from April 2017, Endo’s Par subsidiary has launched the first US generic versions of BioMarin’s Kuvan (sapropterin) tablet and powder formulations. Rival ANDA sponsor Dr Reddy’s has followed suit on the tablet formulation.
