The United States Court of Appeals for the District of Columbia Circuit has affirmed an earlier federal court decision upholding Pfizer's six-month pediatric exclusivity for its top selling anti-fungal medicine, Diflucan. Pfizer said the decision prohibits generic competition for the drug until after July 29, 2004.

The ruling is in response to an appeal by Indian pharmaceutical manufacturer Ranbaxy Laboratories Limited, which had filed suit contending that its generic version of Diflucan was not subject to the exclusivity period for Pfizer's product. The U.S. District Court for the District of Columbia upheld the position of Pfizer and the FDA and ruled against Ranbaxy on March 10.

"The decision by the Court of Appeals, like the District Court decision, strongly supports the public health purpose Congress had in mind when it created an incentive for research-based companies to fund and conduct studies for the benefit of pediatric patients," said Jeff Kindler, Pfizer's General Counsel.

Diflucan is the world's leading systemic anti-fungal, with global sales of approximately $1.2 billion in 2003. Since its introduction, the medicine has been used by approximately 10 million patients worldwide.

The Ranbaxy decision represents Pfizer's latest success in responding to legal actions challenging the company's patents and marketing exclusivity. On February 27, the U.S. Court of Appeals for the Federal Circuit issued a ruling preventing generic manufacturer Dr. Reddy's Laboratories from launching an alternative salt version of Pfizer's hypertension treatment, Norvasc. The decision provides Norvasc with marketing exclusivity through September 2007, the date of expiry of Pfizer's besylate salt patent.

"These decisions properly recognize the significant efforts of our research and development teams in discovering and developing innovative, life-saving medicines to address unmet medical needs," Kindler said.