Ranbaxy Laboratories might just be able to launch the blockbuster drugs Valtrex and Flomax in the US in the stipulated timeframe, industry sources believe. Valtrex (valacyclovir hydrochloride), the innovator product of British major GlaxoSmithKline, is an antiviral used in treating herpes, with a global sales potential of $1.3 billion.
Flomax (tamsulosin), the innovator product of Yamanouchi Pharmaceuticals (now a part of Astellas Pharma) marketed by companies like Boehringer-Ingelheim, is used for treating benign prostrate hyperplasia or the enlargement of the prostrate gland in men and has a sales potential of $1.2 billion globally.
Ranbaxy holds a first-to-file status for the abbreviated new drug application for both the drugs. This gives it a six-month sales exclusivity in the US, meaning it would be the only company other than the innovator to market the product in the country during this period. Clearly, the Gurgaon-based company, now a subsidiary of Japanese innovator Daiichi Sankyo, can rake in much moolah if it succeeds in launching them in the US in the stipulated timeframe.
Going by experts, Ranbaxy could get as much as $160-200 million during the 180-day exclusivity period if it is able to launch Valtrex in December. From Flomax, on the other hand, expected to be launched in March 2010, the company could garner about $150 million during the six-month exclusivity.
But for that, it must first clear the US FDA hurdle.Applications for Valtrex and Flomax were filed from the company’s Dewas facility in Madhya Pradesh, which has been under the FDA lens since September last year. Following an inspection of the facility, the US watchdog had issued warning letters and import alert expressing concern over deviations from current good manufacturing practices.
A re-inspection by the US FDA is due anytime now and industry sources believe the company would be able to satisfy the FDA this time around. A Ranbaxy spokesperson said the company is working with the FDA to solve the issue. “But no timeframe can be given on when exactly the re-inspection would take place or the amount of time it will take.”
A senior research analyst tracking the company, however, said, “Re-inspection would happen before the launch of the generic for Valtrex, which is December this year.”
The re-inspection would be only for the Dewas facility, and not for the Paonta Sahib facility in Himachal Pradesh, which has in addition to the warning letter, the Application Integrity Policy invoked by the FDA, implying that the regulator has doubts about the data submitted by the company and the issue could thus take longer to get solved.
Ranbaxy manufactures about 30 generic formulations and 7 active pharmaceutical ingredients (raw materials for manufacturing the drugs) at the two facilities. Notably, the FDA issue had led to Ranbaxy missing the deadline to launch the generic version of GSK’s billion-dollar migraine drug Imitrex in December 2008. As of last fiscal, 24% of Ranbaxy’s sales were in the US market.
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