INDIAN drug maker Dr Reddy’s Laboratories (DRL) has won a lawsuit it
was facing in the US market on patent infringement in the sale of
Omeprazole, a drug used to treat acidity.
A US district court granted a summary judgment that the Omeprazole Mg OTC ANDA filed by the Indian pharmaceutical company does not infringe the patents in a suit related to Astra Zeneca Laboratories.
The judgement in favour of Dr Reddy’s will enable the company to sell its drug Omeprazol in the US market. It has already applied to the US Food and Drug Administration for its ANDA approval and is waiting to hear from the apex body, said a comapny spokesperson.
“We have submitted our ANDA filing and are awaiting FDA response. At this point in time, we will continue to work through the regulatory approval process while simultaneously progressing manufacturing and commercial preparation,” said Amit Patel, Head of Dr Reddy’s North American operations.
The US-based company had earlier filed a lawsuit against DRL for patent infringement as Omeprazole Mg is a generic version of the Prilosec OTC, a branded drug manufactured by Astra Zeneca Laboratories.
Omeprazole Mg is used for the treatment of acidity and DRL will be the third manufacturer and supplier of this drug in the US market. The brand product has annual sales of approximately $362 million in the United States, based on IRI sales data as of July 2008.
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