Mylan NV, a global pharmaceutical company, announced the US launches of the first generic versions of Daiichi Sankyo's Benicar and Benicar HCT, olmesartan medoxomil tablets, 5 mg, 20 mg and 40 mg, and olmesartan medoxomil and hydrochlorothiazide tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg, respectively.
Mylan received final approval from the US Food and Drug Administration (FDA) for its Abbreviated New Drug Applications (ANDA) for these products.
Olmesartan medoxomil tablets are indicated for the treatment of hypertension, along or with other antihypertensive agents, to lower blood pressure. Olmesartan medoxomil and hydrochlorothiazide tablets are indicted for the treatment of hypertension to lower blood pressure, and are not indicated for the initial therapy of hypertension.
Olmesartan medoxomil tablets, 5 mg, 20 mg and 40 mg, had US sales of approximately $1 billion for the 12 months ending August 31, 2016, according to IMS Health. Olmesartan medoxomil and hydrochlorothiazide tablets, 20 mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg had US sales of approximately $805 million during that same time.
Currently, Mylan has 237 ANDAs pending FDA approval representing $94.4 billion in annual brand sales, according to 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.