Indian pharma companies are really making strides in the US market. Hyderabad-based drug major Dr Reddy’s Laboratories on Monday said it had launched anti-osteoporosis drug Ibandronate Sodium in tablet form and 150 mg dosage in the US market. This drug is the generic version of is the generic version of Swiss pharma giant Roche’s Boniva brand that is used to treat and prevent post-menopausal osteoporosis. The generic drug was launched in the US market on June 29, 2012, after its abbreviated new drug application (ANDA) for the drug was approved by the US drug regulator US Food & Drug Administration, DRL said.
Roche’s Boniva and its generic versions clocked sales of around $486 million in the US market for the 12 months ended March 2012, according to IMS Health data. The company said its Ibandronate sodium 150 mg tablets were available in cartons of three blister packs containing one tablet each for a once a month dosage. The Swiss drugmaker and Dr Reddy’s had been locked in a long-drawn patent infringement dispute over Boniva. Roche had first sued DRL in a US court in 2007 after the Hyderabad-based company sought USFDA approval for its ANDA for the Boniva generic. Later in October 2010, Roche had again slapped a lawsuit against Dr Reddy’s over Boniva in a US court.