With the regulatory approvals in place, pharmaceutical major Dr Reddy’s Laboratories is gearing up to launch the much-awaited generic version of anti-histamine drug Allegra D24 Hour in the US market.
The company, which has been waiting for over 30 months now for the US approvals, got the FDA nod for Allegra D24 on Wednesday.
“We are preparing to launch the drug in the US market in the first quarter of FY11,” a company spokesman told DNA.
Though the company officials refused to comment on the market opportunity and the revenues Dr Reddy’s would garner, estimates peg the potential at about $180 million in the US currently.
“There is no other filer for the drug. So, the opportunity is not going to be for the short-term since there is not going to be any immediate competition,” he said.
Allegra-D 24 Hour is used to treat sneezing, cough, runny or stuffy nose, itchy or watery eyes, hives, skin rash, itching, and other symptoms of allergies and common cold.
Allegra-D 24 Hour tablets contain 180 mg fexofenadine hydrochloride for immediate release and 240 mg pseudoephedrine for extended release.Fexofenadine is an antihistamine that reduces the natural chemical histamine in the body.
Histamine can produce symptoms of sneezing, itching, watery eyes, and runny nose. Though having the status of first to file (FTF) to introduce the generic version of the Aventis drug, the company’s application was under stay under the Hatch-Waxman Act, which was designed to promote generics while leaving intact a financial incentive for research and development.
The provisions of the Act grant a 30-month stay to drug companies that file suit against generic manufacturers that challenge their patents.
The FDA has approved the company’s application on expiration of the stay period. Analysts reacted positively to a situation where the company launches the drug on its own.
Abhishek Singhal and Amit Sinha, analysts with Macquarie Equity Research, in a report on Wednesday, said, “We value this opportunity at Rs 15 per share based on the discounted cash flow of one-time profits during the limited competition window. If Dr Reddy’s launches the product at risk, we estimate this would boost reported earnings per share by about Rs 9 and Rs 5, respectively, by FY11 and FY12.”
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