Mylan launches generic hypertension drugs Benicar and Benicar HCT in US

Global pharmaceutical giant Mylan has made a significant stride in the hypertension treatment market with the US launch of the first generic versions of Daiichi Sankyo’s Olmesartan Medoxomil tablets, known commercially as Benicar and Benicar HCT.

Introduction of Generic Hypertension Treatments

Benicar, available in doses of 5 mg, 20 mg, and 40 mg, and its combination counterpart Benicar HCT, available in doses of 20mg/12.5 mg, 40 mg/12.5 mg, and 40 mg/25 mg, have received final approval from the U.S. Food and Drug Administration (FDA). Mylan’s entry into the market with these products is poised to provide more affordable hypertension treatment options for patients.

Market Impact and Sales Figures

The significance of this launch is underscored by sales figures from IMS Health, which reported approximately $1 billion in US sales for Olmesartan Medoxomil and $805 million for Olmesartan Medoxomil Hydrochlorothiazide in the twelve months ending August 31, 2016. These substantial figures reflect the critical need for effective hypertension management solutions.

Mylan’s Strategic ANDA Portfolio

Mylan currently has 237 Abbreviated New Drug Applications (ANDAs) pending FDA approval, with 41 of these holding potential first-to-file opportunities. This represents a considerable portion of the $94.4 billion in annual brand sales, indicating Mylan’s significant potential impact on the pharmaceutical market.

Considerations and Warnings

It’s essential to note that, like many hypertension drugs, Benicar and Benicar HCT are contraindicated during pregnancy due to their action on the Renin-Angiotensin System (RAA pathway), which can potentially cause injury or death to the developing fetus.

Mylan’s Global Presence and Product Diversity

Mylan is one of the world’s largest producers of Active Pharmaceutical Ingredients (APIs) and markets over 2,700 generic and branded pharmaceuticals in more than 165 countries. The company’s extensive range includes critical antiretroviral therapies relied upon by over 50% of people treated for HIV/AIDS globally.

The introduction of generic versions of Benicar and Benicar HCT by Mylan could significantly alter the landscape of hypertension treatment, offering more accessible options for patients. This development not only supports healthcare affordability but also enhances patient access to essential medications.