NEW DELHI, June 13: Drug firm Lupin Ltd has launched its generic Ciprofloxacin, used for treating bacterial infections, in the American market and is expecting 180 days of market exclusivity.
The company’s US subsidiary, Lupin Pharmaceuticals Inc (LPI) has launched its Ciprofloxacin for oral suspension in the US market in the strengths of 5 g/100 mL (250mg/5 mL) and 10 g/100 mL (500 mg/5 mL), Lupin said in a statement.
The company had earlier received final approval for the product from the United States Food and Drug Administration (USFDA), it added.
“Lupin is the first applicant to file an Abbreviated New Drug Application (ANDA) for Cipro oral suspension in 250 mg/ml & 500 mg/ml and as such is entitled to 180 days of marketing exclusivity,” the company said.
The company’s product is the generic equivalent of Bayer HealthCare Pharmaceuticals Inc’s Cipro oral suspension in the same strengths, Lupin said.
Cipro oral suspension had annual US sales of USD 8.6 million as per IMS MAT March, 2014, it added.
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