The first generic versions of Roche-owned Genentech's Boniva, a once-monthly product to treat or prevent osteoporosis in women after menopause, has been cleared by the FDA.
The manufacturers that have gained FDA approval to make generic 150 milligram Boniva are Apotex Inc., Orchid Healthcare, and Mylan Inc. (MYL).
The once-monthly branded version of oral 150 mg Boniva was approved by the FDA in March 2005 while the 2.5 mg daily formulation of Boniva was approved in 2003. Sales of Boniva were 696 million Swiss francs in 2011, down from 1,013 million Swiss francs in 2010.
According to the National Institutes of Health, in the United States more than 40 million people either already have osteoporosis or are at high risk due to low bone mass. Medications like Boniva, which belong to a class called bisphosphonates, help increase bone mass and reduce the chance of having a spinal fracture.
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