Financial Daily from THE HINDU group of publications
Wednesday, Sep 10, 2003
Financial Daily from THE HINDU group of publications Wednesday, Sep 10, 2003 |
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Corporate
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Corporate Disputes Industry & Economy - IPR Glaxo files suit against Dr Reddy's for patent breach Our Bureau
Hyderabad , Sept 9 THE global pharmaceutical giant GlaxoSmithKline, has filed a lawsuit against Dr Reddy's Laboratories Ltd, the Hyderabad-based pharma major, in the US Courts alleging infringement of its patents pertaining to Rosiglitazone Maleate, a type-2 diabetes drug, by the latter. Rosiglitazone Maleate is the generic version of GlaxoSmithKline's Avandia, indicated for the management of type-2 diabetes. The brand had annual sales in the US market of about $1.1 billion. The lawsuit was in response to the abbreviated new drug application (ANDA) filed by Dr Reddy's with the US Food and Drug Administration (USFDA) for Rosiglitazone Maleate tablets, equivalent to 2mg, 4mg and 8mg, with paragraph-IV certification on two of the three Orange Book patents listed for the drug. In a press release here, Dr Reddy's said it had notified GlaxoSmithKline, upon which the latter filed a lawsuit against the company in the US District Court for the District of New Jersey, alleging patent infringement on the `803 patent. According to Dr Reddy's, it believes that it has the first-to-file status on all dosage strengths and if successful in its litigation, would enjoy a 180-day marketing co-exclusivity pursuant to the July 2003 FDA guidance on 180-day exclusivity when multiple ANDAs were filed on the same day.
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