Lupin’s US subsidiary, Lupin Pharmaceuticals Inc. (LPI) has launched its Ciprofloxacin for Oral Suspension, 5 g/100 mL (250mg/5 mL) and 10 g/100 mL (500 mg/5 mL) in the US having received final approval from the FDA earlier.
Lupin’s Ciprofloxacin Oral Suspension, 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500 mg/5 mL) is the generic equivalent of Bayer HealthCare Pharmaceuticals, Inc.’s (Bayer) Cipro Oral Suspension 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500 mg/5 mL) and indicated for the treatment of infections caused by susceptible isolates of the designated microorganisms in various conditions and patient populations.
Lupin is the first applicant to file an ANDA for Cipro Oral Suspension 250 mg/ml & 500 mg/ml and as such is entitled to 180 days of marketing exclusivity. Cipro Oral Suspension had annual US sales of $8.6 million, as per IMS MAT March, 2014.
