AstraZeneca sues DRL over Accolate

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Mumbai, Jul 8: The United States, the largest pharmaceuticals market in the globe, still lures Indian generic firms to grab a pie of the patent protected drugs through the litigation route. In the latest incident, Dr Reddy's Labs (DRL) has been sued by US major, AstraZeneca, following DRL's paragraph IV abbreviated new drug application (ANDA) submission for marketing Accolate, the US firms' leading drug used to treat asthma.

In a suit filed on June 27 in the district court of New Jersey, AstraZeneca has accused DRL of infringing their patents for zafirlukast (Accolate) with DRL's proposed generic version. Last month, Ranbaxy's acquirer, Daiichi Sankyo, had also filed an infringement suit in the US against Matrix Labs for alleged infringement of the patents for its anti-hypertension drug Azor following Matrix' ANDA submission.

The attraction of getting 180-day marketing exclusivity if it wins the litigation compels the Indian firms for filing more paragraph IV ANDAs with the US Food and Drug Administration (FDA) despite the litigation cost increasing drastically. In February, FE had reported that drugs worth about $20 billion are losing its patent protection in the US this year. According to IMS Health, by 2011, drugs worth some $60 billion will become off patent.