Mumbai: Glenmark Generics Ltd, granted final approval by the US Food and Drug Administration (FDA) to sell the generic version of traumatic skin lesion drug mupirocin calcium cream on Friday, is set to have generic market exclusivity of almost two years in the US.
“We expect Glenmark to earn a sales and net profit close to $11 million (around Rs.61 crore) and $6 million, respectively, during the exclusivity period in the first nine months,” said pharma industry analyst Hitesh Mahida of Fortune Equity Brokers (India) Ltd.
The Indian company is the first generics maker to get FDA approval for mupirocin calcium cream, patented and sold exclusively by British drug maker GlaxoSmithKline in the US market under the brand name Bactroban.
Glaxo’s patent for the drug expires in October 2014. Since Glenmark’s application seeking marketing approval for the generic version was filed before Glaxo listed its patent in the US, the Indian company can start selling the drug immediately.
Glenmark will be able to have exclusive status until October 2014 as other generic brands can enter the market only after Glaxo’s patent expiry as per the current regulatory regime.
“Glenmark will commence shipping (the drug) immediately,” the company said in a statement on Monday.
The first generic company to gain FDA marketing approval for a drug typically gets six months of marketing exclusivity, and hence greater margins, before other copies made by others are allowed to be sold.
US law allows companies to seek marketing permission for generic versions five years before the expiry of a patent. And, sales usually start after the patent expires, except in this case because Glaxo listed the patent only in 2011, said a person familiar with the development who didn’t want to be named.
Mupirocin calcium cream is indicated for the treatment of secondarily infected traumatic skin lesions due to susceptible strains of bacteria S. aureus and S. pyogenes. According September 2012 data from pharma market researcher IMS Health, Bactroban had US sales of $56.5 million in for the 12 months ended September 2012.
“We expect it to remain a limited competition opportunity for Glenmark post exclusivity also,” said Mahida of Fortune Equity.
“Mupirocin Calcium cream is difficult to develop and that’s the reason for the zero generic competition and this was the same reason for others not to attempt the Glenmark route to apply for the generic approval when Glaxo did not list its patent in the market till 2011,” said the person cited above.
Glenmark shares, which rose 6.74% to Rs 513.05 on Friday, fell 1.75% on BSE on Monday to Rs 504.05. The Sensex ended unchanged at 20,103.35 points.