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Mylan Inc. and Watson Pharmaceuticals Inc. have received approval from the Food and Drug Administration to launch a generic version of Roche’s Boniva osteoporosis medication.
Mylan said Tuesday that its Mylan Pharmaceuticals Inc. has begun shipping ibandronate sodium tablets 150 mg.
Boniva, indicated for the treatment and prevention of osteoporosis in postmenopausal women, had U.S. sales of about $517 million for the 12 months ended Dec. 31, according to IMS Health data cited by Mylan.
Meanwhile, Watson said Tuesday that it plans to start shipping ibandronate 150-mg tablets in the second quarter.
The company said Roche has sued Watson for patent infringement in connection with Watson’s abbreviated new drug application (ANDA) for ibandronate 150-mg tablets. The lawsuit remains pending, according to Watson.
