Dr Reddy’s Laboratories, Hyderabad-based pharma major, has launched the bio-equivalent version of allergy drug Allegra D24 in the US market. The drug - fexofenadine hydrochloride-pseudoephedrine hydrochloride - of Dr Reddy’s has already started selling in drug stores in the US.
The company’s drug in 180 mg and 240 mg strengths are being sold on store labels.
Dr Reddy’s has shifted the strategy from tapping the prescription market to the over-the-counter market after the innovator Sanofi Aventis resorted to the move.
However, there is no previous market data available for the drug since it is for the first time an allergy drug is being sold in the stores.
“First of all there is no market data. Additionally, this particular drug is used for allergies including cold and the sales then become seasonal. One can expect a cyclical trend in the revenues accrued from the drug sales,” a source told DNA.
The data that is available for the prescription format pegs the market size of the drug at about $150 million.
Not willing to provide any estimates on the sales, a Dr Reddy’s official said, “The actual numbers would become available over a year. We are also tying up with the drug stores in the US and the drug will be launched with their labels. So one should wait for the ramp-up to see the actual numbers.”Generic Allegra D24 is used for treating sneezing, cough, runny nose, watery eyes and other symptoms of allergies and common cold.
The US District Court had earlier granted a preliminary injunction on the launch of Allegra-D24, following a request filed by the innovators, Albany Molecular Research Inc and Sanofi Aventis.
Meanwhile, the much-hyped product of the company — Fondaparinux — is also said to be ramping up in the US market. Dr Reddy’s had launched the generic Arixtra in collaboration with Alchemia and does not see any immediate competition for the drug. However, an authorised generic of the drug is already being sold in the US market and the market data indicates at the two generics apart from the branded drug garnering about 50% of the market.
Arixtra is an injectable heparin substitute. So the drug finds more market through the hospital channel.
However, Dr Reddy’s is seen working out a combination of hospitals and retail stores.
“We have assumed base market share of 35% with 50% price erosion on fondaparinux (after authorised generic’s entry). Given the presence of authorised generic, Alchemia is now entitled to 50% of operating profits (against 60% earlier), Girish Bakhru and DamayantiKerai of HSBC Securities and Capital Markets, said in their report on August 30, 2011.
“Alchemia expects profit sharing to begin from 2012 once profitability builds up in the product. We believe competition is likely to remain limited (only 2 DMFs - Apicore and Reliable so far) in this molecule given technological barrier and manufacturing complexity,” the analysts said