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    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).

    Related: Actavis gains final FDA approval for generic Subutex

    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.

    Related: HSCA to FDA: Address backlog of generic drug applications

    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.

    Read more: Diabetes complications fuel rising costs

    Christine Blank
    Contributing Editor Christine Blank is a freelance writer based in Florida.


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