Mylan launches generic of Benicar after FDA approval
Mylan has launched the first generic version of Daiichi Sankyo’s Benicar (olmesartan medoxomil) and Benicar HCT (olmesartan medoxomil and hydrochlorothiazide) in the US.
The US Food and Drug Administration (FDA) approved Mylan’s Abbreviated New Drug Application (ANDA) for these products.
Benicar is used for the treatment of high blood pressure.
In the 12-month period ending August 31, 2016, Benicar had US sales of approximately $1 billion, while Benicar HCT had US sales of around $805 million.
Mylan has 237 ANDAs pending FDA approval, representing $94.4 billion in annual brand sales, according to IT and technology services company IMS Health.
“Forty-one of these pending ANDAs are potential first-to-file opportunities, representing $32.5 billion in annual brand sales for the 12 months ending June 30, 2016, according to IMS Health,” said Mylan in a statement.
