Lupin Pharmaceuticals Inc (LPI), the company’s US subsidiary, has launched its generic Gatifloxacin Ophthalmic Solution 0.5 per cent in the US market, after having received the USFDA’s final approval earlier, Lupin Ltd said in a statement.
"Zymaxid Ophthalmic Solution 0.5 per cent had annual US sales of around USD 62.3 million (IMS MAT June 2013 data). Lupin was the first applicant to file an abbreviated new drug application (ANDA) for Zymaxid Ophthalmic Solution and as such will be entitled to 180 days of marketing exclusivity," the company said.
Gatifloxacin Ophthalmic solution 0.5 per cent, which is the generic equivalent of Zymaxid Ophthalmic Solution of Allergan, is indicated for the treatment of bacterial conjunctivitis.
"Having received approval earlier, we are happy to now launch this product. The product is the first of the ophthalmic products that Lupin is bringing to the market and bears testimony to our continued commitment to serving our customers and patients by bringing high quality," Lupin Ltd Managing Director Nilesh Gupta said.
Lupin has been focusing on less competitive specialities spaces in the US market which includes segments like Oral Contraceptives, Ophthalmology and Dermatology. The Mumbai-based company has already done over 10 filings with the US FDA for ophthalmological products.
The company’s cumulative ANDA filings with the US FDA as of June 30, 2013 stood at 177, with the company having received 86 approvals to date.
Shares of Lupin were trading at Rs 863.45 on the BSE in morning trade, up 1.33 per cent from its previous close.