Barr Laboratories Inc has began shipping Ciprofloxacin Hydrochloride Tablets, 250 mg, 500 mg and 750 mg, pursuant to a license from Bayer Corporation (Bayer). The Company is distributing the ciprofloxacin products as part of a 1997 settlement of a patent challenge that Barr initiated against Bayer's Cipro antibiotic. Cipro is patent protected until December 9, 2003.
"We are pleased to add this important therapy to our product portfolio," said Bruce L. Downey, Barr's Chairman and CEO. "As a result of our patent challenge settlement, we will be distributing an alternative brand ciprofloxacin product six months prior to patent expiry."
Under the terms of a non-exclusive supply and distribution agreement, Barr purchases ciprofloxacin products that are manufactured under Bayer's New Drug Application (NDA) for Cipro(R) directly from Bayer. Barr will market the ciprofloxacin products under its own label. The agreement provides Barr with the right to distribute the ciprofloxacin products until the patent protecting Bayer's Cipro expires in December 2003.
The Company added that Bayer has indicated that it will seek pediatric exclusivity for Cipro, which, if granted, could delay the introduction of generic versions for six months beyond the expiration of the patent. Barr and Bayer are currently negotiating an agreement that, if finalized, would allow Barr to continue distributing ciprofloxacin products during Bayer's pediatric exclusivity period for Cipro.
Ciprofloxacin is an antibiotic used to treat various types of infections, including urinary tract infections. Barr's distributed ciprofloxacin product will compete in a market that had annual sales of approximately $1.1 billion for the twelve months ending March 2003.