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US court ruling on DRL-Pfizer case on Dec 17

Our Bureau

HYDERABAD, Dec 12

DR Reddy's Laboratories Ltd, the Hyderabad-based pharmaceutical major said the District Court in New Jersey, United States had heard on Wednesday the oral arguments on the company's motion to dismiss Pfizer's complaint pertaining to patents on Amlodipine Maleate, the generic version of Pfizer's blockbuster drug Norvasc.

In a press release here on Thursday, Dr Reddy's said though the Court announced no decision, it had indicated its intention to issue an opinion at around 4 p.m. on December 17.

Earlier, Dr Reddy's filed a new drug application (NDA) for Amlodipine Maleate under the provisions of the Federal Food, Drug and Cosmetic Act during December last year. The company had filed a Paragraph IV Certification on the two Orange Book patents listed for Pfizer's Norvasc - the '909 and '303 patents.

Responding to this, Pfizer notified Dr Reddy's on June 17 this year that it had filed a suit in the Federal Court in New Jersey on one of the two Orange Book patents - the '909 patent. Pfizer did not file a suit on the second patent. Subsequently, Dr Reddy's filed a motion to dismiss Pfizer's complaint, the oral argument for which was heard on December 11.

According to Dr Reddy's, the US Food and Drug Administration (FDA) during October this year determined the NDA submitted by the company for Amlodipine Maleate as `approvable'. However, the company said the final approval of the NDA was contingent upon the successful completion of ongoing discussions with the FDA regarding issues relating to specific chemistry manufacturing controls and product labelling.

Final approval was also contingent upon a successful outcome in the patent term extension litigation with Pfizer in the US courts, Dr Reddy's release said.

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