Updated: Reddy's Follows Endo On US Kuvan Launch

Sapropterin Market Worth Roughly $500m

 
• By Dean Rudge
  
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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.

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Both Endo and Reddy's have now launched generic Kuvan tablets following patent-litigation settlements • Source: Shutterstock

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.

Par’s and Reddy’s market entries, which follow separate settlement agreements resolving US patent litigation, come years ahead of the expiry...

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