Lupin launches generic ophthalmic solution in US market

Drug major Lupin today said it has launched the generic version of Allergan Inc’s ZymaxidOphthalmic Solution in the US market with 180 days of marketing exclusivity.

Lupin Pharmaceuticals Inc (LPI), the company’s USsubsidiary, has launched its generic Gatifloxacin OphthalmicSolution 0.5 per cent in the US market, after having receivedthe USFDA’s final approval earlier, Lupin Ltd said in astatement.

“Zymaxid Ophthalmic Solution 0.5 per cent had annual USsales of around $62.3 million (IMS MAT June 2013 data).Lupin was the first applicant to file an abbreviated new drugapplication (ANDA) for Zymaxid Ophthalmic Solution and as suchwill be entitled to 180 days of marketing exclusivity,” thecompany said.

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Gatifloxacin Ophthalmic solution 0.5 percent, which isthe generic equivalent of Zymaxid Ophthalmic Solution ofAllergan, is indicated for the treatment of bacterialconjunctivitis.

“Having received approval earlier, we are happy to nowlaunch this product. The product is the first of theophthalmic products that Lupin is bringing to the market andbears testimony to our continued commitment to serving ourcustomers and patients by bringing high quality,” Lupin LtdManaging Director Nilesh Gupta said.

Lupin has been focusing on less competitive specialitiesspaces in the US market which includes segments like OralContraceptives, Ophthalmology and Dermatology.

TheMumbai-based company has already done over 10 filings with theUS FDA for ophthalmological products.

The company’s cumulative ANDA filings with the US FDA asof June 30, 2013 stood at 177, with the company havingreceived 86 approvals to date.

Shares of Lupin were trading at Rs 863.45 on the BSE inmorning trade, up 1.33 percent from its previous close.

PTI