Dr Reddy’s launches generic hypertension drug in US

Dr Reddy’s launches generic hypertension drug in US

Hyderabad: Pharmaceutical firm Dr Reddy’s Laboratories Ltd on Monday said it has launched in the US a generic version of Swiss pharmaceutical firm Novartis International AG’s hypertension drug, after getting regulatory approval earlier in April.

It will have to compete with Lupin Ltd, Teva Pharmaceutical Industries Ltd and Sandoz Inc., which already sell versions of the drug in the US.

The US market for amlodipine benazepril, marketed as Lotrel by Novartis, has shrunk to $572 million (around Rs2,500 crore) with the entry of generics into what was originally a $1.2 billion market.

While the last of the patents on Lotrel will expire only in 2017, there is a likelihood that more players will enter the market within the year, further eroding prices, say analysts.

Analyst Manoj Garg of Emkay Global Financial Services Ltd estimates the generic drug to add Rs4.6 to the brokerage’s earnings-per-share estimate of Rs62 for Dr Reddy’s in fiscal 2011.

Among other likely major launches by Dr Reddy’s this quarter are the copies of anti-allergy drug Allegra D24 (fexofenadine), for which it received approval from the US Food and Drug Administration (FDA) in March, and anticoagulant fondaparinux, for which approval is pending.

Allegra’s US sales are pegged at about $180 million, and at $200 million for fondaparinux, said Garg.

Dr Reddy’s posted a loss of Rs233 crore for the March quarter as its German subsidiary Betapharm Arzneimittel GmbH continued to suffer in an unfavourable pricing regime.

As of January, the company had 62 applications for generic drugs pending with the US FDA.

Amlodipine benazepril is a combination drug to manage high blood pressure when the components, amlodipine or benazepril, are independently adequate.

Dr Reddy’s stock closed up 2.6% at Rs1,244.80 on the Bombay Stock Exchange on Monday, on a day the benchmark Sensex rose 0.29%.