With the approval of Cipro XR (Ciprofloxacin Extended-Release Tablets), the new antibiotic product of Bayer AG by the US Food and Drug Administration, Ranbaxy Laboratories Limited (RLL), the company which has outlicensed the product to the German pharma major is expecting milestone royalty on sales of Cipro XR 500 mg Tablets.

The new formulation, given once a day over three days, is designed to treat uncomplicated urinary tract infections (UTIs).

The chances of royalty was clear months ago after Bayer AG presented an encouraging picture of the human trials of the 500 mg Cipro OD (renamed Cipro XR by Bayer), outlicensed by Ranbaxy Laboratories Limited to Bayer AG, Ranbaxy.

Bayer had submitted an application to the USFDA in October 2002 to market Cipro® XR tablets in a 1000 mg dosage strength for once-a-day therapy of complicated urinary tract infections.

With the approval, Bayer will now be marketing Cipro XR in a dosage strength of 500 mg, and the product is to be available in U.S pharmacies on January 2, 2003.

Cipro XR releases the active ingredient from two layers. The first releases ciprofloxacin into the blood within hours. This is followed by a second extended release of the active ingredient to allow sustained levels over 24 hours.

The NDDS springs from Ranbaxy''s patented gastro-retentive drug-delivery technology that will help extend the life cycle of ciprofloxacin worldwide.

The company, had launched the product in the Indian market last year itself under the brand name Cifran OD. Till the launch, ciprofloxacin was required to be taken twice a day, making patient compliance difficult.

It is known that 500 mg Cipro XR given once-a-day over three days for uncomplicated urinary tract infection (UTI) was comparable in safety and efficacy to the conventional twice-daily dose (250 mg) of Cipro.