Dr.Reddy lab launches a generic version of Kuvan(sapropterin dihydrochloride) used in treatment of Phenylketonuria.
Phenylketonuria(PKU) is an inherited disorder of amino acid(phenylalanine) metabolism with frequency of 1:10,000. Most newborns in the US, Europe and Australia are screened to diagnose early and treatment to be continued for life long.
Kuvan(sapropterin dihydrochloride) used in conjunction with Phenylalanine restricted diet in patients with PKU. BioMarin got US FDA approval for Kuvan in 2007 which is the first specific drug therapy for PKU.
Global sales of Kuvan was $489 million for 12 months ended June 2020. (source:https://www.prnewswire.com/news-releases/endo-begins-shipment-of-generic-kuvan-tablets-and-powder-for-oral-solution-sapropterin-dihydrochloride-301144510.html)
Par pharma (subsidiary of Endo pharma) has launched both oral and powder form for oral solution, Dr Reddy launched an oral tablet at 100 mg strength.
It must be a limited competition drug without much price erosion in near future as the US FDA orange book doesn’t show any other company name except innovator Biomarin and Par pharma. ( I can’t even see Dr Reddy lab name here. I must be missing something)
Discl: tracking quantity