U.S. health regulators have approved the first low-cost versions of Roche’s blockbuster osteoporosis drug Boniva, which is used to prevent bone fractures.
Boniva, known generically as Ibandronate, is taken once a month to treat or prevent osteoporosis.
The Food and Drug Administration said it approved generic versions of the drug from three companies: Apotex Inc., Orchid Healthcare and Mylan Pharmaceuticals Inc. They have gained approval to make generic 150-milligram ibandronate tablets, the FDA said.
Generic drugmakers are allowed to launch cheaper versions of drugs after their patents have expired. Generic versions can cost anywhere from 30 to 80 percent less than the original branded drug. And, now that the patent has expired on Boniva, generic drugmakers are able to tap into an exceptional market. According to IMS Health, US sales of Boniva amounted to $510 million for the year, ending January 31, 2012.