Tamsulosin Hydrochloride (Flomax) is the innovator product of Japanese firm Yamanouchi Pharmaceuticals (now a part of Astellas Pharma), marketed by companies like Boehringer-Ingelheim, and has a global sales potential of $1.2 billion.
It is used in the treatment of benign prostrate hyperplasia or the enlargement of the prostrate gland in men.
In November 2007, the Gurgaon based Ranbaxy entered into a settlement over Flomax and was to launch the generic version of the product in the US market in March 2010.
Having the first-to-file (FTF) status for the abbreviated new drug application (ANDA), Ranbaxy earned an 180-day exclusivity in the US, meaning other than the innovator it
would be the only player to market the product during this period.
However, the last week's settlement of US based Impax Laboratories' patent litigation with Astellas and Boehringer-Ingelheim over the generic version of Flomax implies that Impax can market the drug from March 2, 2010, (subject to US Food and Drug Administration approval), and thus Ranbaxy would have to share its 6 month exclusivity with Impax.
During the exclusivity, other than the innovator company, Ranbaxy would have to face competition from Impax as well, which would very well mean lower sales that what was earlier estimated.
Industry experts had envisaged sales of $150-210 million in the US during the exclusivity period for the product.
However, the Impax settlement limits upside in revenues for Ranbaxy with an additional player in the US market, says research analyst Bhavin Shah from Dolat Capital Market.
"It also remains to be seen whether Ranbaxy's Dewas facility would get the clearance from the FDA. Only then can Ranbaxy go ahead and introduce the generic version of Flomax in the market," said an industry expert from a brokerage firm.
A Ranbaxy spokesperson said the company did not comment on individual products.
Application for Flomax was filed from Ranbaxy's Dewas facility in Madhya Pradesh which has been under the US FDA scanner since September last year, with the US drugs watchdog issuing warning letters and import alert expressing concern over deviations from current good manufacturing practices.
A re-inspection of the facility is due soon and industry experts believe the company would be able to satisfy the FDA this time.
The Ranbaxy spokesperson said the company is working with the FDA to resolve the matter, but no timeframe can be given on when exactly the re-inspection would take place or the time it would take.
The US is a key market for the company with about 24% of its sales last fiscal coming from the US.