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HYDERABAD, Aug. 14

IN a setback to its global generics business, Dr Reddy's Laboratories Ltd has been made to withhold the launch of its Ciprofloxacin in the US market till the end of next year.

The `444 compound patent' on Ciprofloxacin, currently held by Bayer Corporation, is scheduled to expire on December 9, 2003.

A three-judge panel of the US Federal Circuit Court of Appeals issued a direction affirming the validity of Bayer's patent on Ciprofloxacin.

As a result of this judgement, Dr Reddy's cannot launch its product until Bayer's patent expires, according to a press release issued by the Hyderabad-based drug company.

Ciprofloxacin is the AB-rated generic equivalent of Bayer Corporation's Cipro, a broad-spectrum antibiotic approved for the treatment of several types of infection.

The US Food and Drug Administration had issued final approval of Dr Reddy's abbreviated new drug application (ANDA) for Ciprofloxacin tablets 100, 250, 500 and 750 mg during July this year.

Dr Reddy's had filed the paragraph IV certifications on all dosages and believed that it was the first to file on the 100 mg, brand sales of which were $1.5 million in 2001. Bayer's had annual US brand sales of around $1.2 billion on Ciprofloxacin.

In an earlier release, the company said it was awaiting the appellate court decision on the patent dispute with Bayer's.

Subsequent to the oral arguments held on January 6 this year in the appellate court, Dr Reddy's said it expected to receive a six-month marketing exclusivity on the 100 mg strength if the court invalidates the `444 compound patent' held by Bayer's.

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