Lupin makes debut in US ophthalmology space with exclusivity for gatifloxacin
This article was originally published in Scrip
Lupin has launched gatifloxacin ophthalmic solution 0.5%, a generic version of Allergan's Zymaxid ophthalmic solution 0.5%, on the US market – its first such launch in the ophthalmology segment there.
Lupin was the first to file an ANDA for Zymaxid ophthalmic solution and will be eligible for 180 days of marketing exclusivity, a company statement said. Zymaxid Ophthalmic Solution, indicated for the treatment of bacterial conjunctivitis, reported sales of about $62.3m for the 12 months to June 2013.
The launch of Lupin's first generic product in the ophthalmology segment is significant in that it opens up a new fork in the firm's US growth plan focused largely on niche segments marked by limited competition such as oral contraceptives.
Lupin's top brass have been upbeat about the possibility of doubling of the firm's US revenues by 2015, given that in addition to the relatively small base just a part of the firm's pipeline is currently on the market there. "We still have only around 50 products on the US market; it's still a fraction of our pipeline. What we have coming over the next couple of years may make a significant pipeline. And our generic business growth has been pretty strong and we expect to continue to maintain the growth momentum," Vinita Gupta, Lupin's CEO, told Scrip in an interview earlier this year (scripintelligence.com, 4 February 2013). Lupin's US arm reported a 54% increase in revenues to INR36,830m ($589.6m ) during 2012-13.
Ms Gupta had also then indicated that with the majority of the firm's oral contraceptive filings and some in the ophthalmology segment having already been made in the US, dermatology and metered dose inhalers (MDIs) were among the next areas of focus. Lupin has made more than 10 filings with the FDA for ophthalmological products.
As of 30 June, Lupin has 177 ANDA filings with the US FDA and has received 86 approvals so far. The indications are that the firm has 30 first-to-file opportunities out of which 14 are exclusive opportunities, many of which are yet to be launched.