Lupin has received final approval for its Doxycycline capsules USP, 50 mg, 75 mg, and 100 mg from the United States Food and Drugs Administration (FDA) to market a generic version of Aqua Pharmaceuticals Monodox capsules 50 mg, 75 mg, and 100 mg.
Lupin’s doxycycline capsules 50 mg, 75 mg and 100 mg are the AB-rated generic equivalents of Aqua Pharmaceuticals, LLC’s Monodox capsules 50 mg, 75 mg and 100 mg and are indicated in the treatment of infections caused by various micro-organisms and as an adjunctive therapy in severe acne.
The company also received final approval from the FDA for its ciprofloxacin for oral suspension, 5 g/100 mL (250 mg/5 mL) and 10 g/100 mL (500 mg/5 mL) to market a generic version of Bayer HealthCare Pharmaceuticals (Bayer) Cipro for oral suspension 5 g/100 mL and 10 g/100 mL.
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’s 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 micro-organisms in various conditions and patient populations.
Lupin is the first applicant to file an ANDA for Cipro oral suspension 250 mg/ml and 500 mg/ml and as such is entitled to 180 days of marketing exclusivity. Lupin Pharmaceuticals, the company’s US subsidiary would commence marketing the products shortly.
Monodox capsules had annual US sales of $180.6 million (IMS MAT Dec, 2013) whereas Cipro oral suspension had annual US sales of $8.6 million (IMS MAT Dec, 2013).
EP News Bureau – Mumbai