First olmesartan generics approved for hypertension

In a big move for patients who take blood pressure medication on a regular basis, FDA last week approved the first generic versions of 4 drugs that contain the blood pressure-lowering medication olmesartan medoxomil (Benicar, Daiichi Sankyo).

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Before its patent expired this year, Benicar was a lucrative drug for Daiichi Sankyo. Daiichi Sankyo also sells Benicar HCT, Azor and Tribenzor, a combination of olmesartan medoxomil, amlodipine besylate and hydrochlorothiazide.

Benicar had US sales of approximately $1 billion for the 12 months ending August 31, 2016, according to IMS Health, while Bencar HCT had US sales of approximately $805 million during the same time period.

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Now, Mylan Pharmaceuticals, Par Pharmaceutical, Torrent Pharmaceuticals, Teva Pharmaceuticals and Macleods Pharmaceuticals are launching generic versions of the 4 drugs. The hypertension drugs are available in several dosage forms, similar to their branded counterparts.

“'First generics' are just what they sound like-the first approval by FDA which permits a manufacturer to market a generic drug product in the United States. FDA considers first generics to be important to public health, and prioritizes review of these submissions,” the agency said on its web site.

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