British specialty biopharmaceutical company Shire Plc (SHPGY, SHP.L) Thursday announced the filing of patent infringement lawsuit against India's Natco Pharma Ltd. related to its renal medication Fosrenol or lanthanum carbonate.
In the lawsuit, filed in the U.S. District Court for the Southern District of New York, the St Helier, Jersey-based company alleges that Natco has infringed upon two of its patents: U.S. Patent No. 5,968,976, or 976 Patent, and U.S. Patent No. 7,381,428, or 428 Patent.
The company stated that it filed the suit in response to an Abbreviated New Drug Application, or ANDA, filed by the Hyderabad-based Natco, which sought the approval of the U.S. Food & Drug Administration, or FDA, for marketing and selling the generic versions of Shire's 500 mg, 750 mg, and 1 g Fosrenol products.
In addition, Shire noted that since the lawsuit had been filed within 45 days of receiving Natco's Paragraph IV notification letter, as warranted under the Hatch-Waxman Act, the FDA would have to refrain from approving Natco's application for 30 months, or until a district court decides that the patents are invalid or not infringed. The stay on generic approval will expire on April 26, 2012, unless terminated earlier, Shire added.
The company has filed similar lawsuits recently, related to the same drug. Patent Infringement lawsuits were filed against Mylan Inc. (MYL), Mylan Pharmaceuticals Inc. and Matrix Laboratories Limited. Earlier to this, it had filed a lawsuit against Barr Laboratories, Inc., a part of Teva Pharmaceutical Industries Ltd. (TEVA).
Shire is on the lookout for newer avenues for revenue. Its best-selling drug, Adderall XR, is supposedly going off patent next month. On Tuesday, Shire entered into a 3-year co-promotion deal with GlaxoSmithKline Plc. (GSK) for Vyvanse capsules CII, indicated for the treatment of Attention Deficit Hyperactivity Disorder, ADHD. The co-promotion deals help drug makers to promote their drugs in new markets and extend sales reach.
SHPGY closed Wednesday's regular trading session on NYSE at $36.10, up $0.16, on a volume of 612,900 shares.
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