The first generic versions of Pfizer's antifungal Diflucan entered the market July 29.

FDA approved numerous ANDAs for tablet, oral suspension and injection forms of fluconazole upon expiration of Pfizer's pediatric exclusivity the same day.

Pfizer is introducing its own generic of fluconazole tablets and oral suspension through its Greenstone subsidiary.

The only Diflucan patent listed in the "Orange Book" had an original expiration date of Jan. 29. Generics were kept from launching by an additional six months of pediatric exclusivity for Pfizer.

Because the Pfizer patent has now expired, none of the ANDA filers will enjoy 180 days of marketing exclusivity.

Ranbaxy had unsuccessfully sought to get a jump on the generic free-for-all. The company sued FDA in January, seeking to force immediate approval of its ANDAs.

The company believed it held 180-day exclusivity rights to the oral suspension form of the drug.

Ranbaxy asserted its ANDAs should not be subject to Pfizer's pediatric exclusivity because there was no court ruling on either validity or infringement when the Pfizer patent expired.

A D.C. federal judge ruled against Ranbaxy in March. The court said FDA did not err in determining that Paragraph IV certifications should be treated as Paragraph IIs when the patent at issue expires, thereby making the Diflucan ANDAs subject to pediatric exclusivity (¹ Also see "Ranbaxy Diflucan Generic Launch Delayed Until July Under Court Ruling" - Pink Sheet, 11 March, 2004.).

An appeals court affirmed that decision in April (² Also see "Ranbaxy Diflucan Generic Delayed Until July, Court Affirms" - Pink Sheet, 30 April, 2004.).

Pfizer reported U.S. Diflucan sales of $329 mil. (up 10%) during the first six months of 2004. Full-year 2003 revenues were $662 mil. in the U.S.

- Sue Sutter

Diflucan Generics Launch Following Expiration Of Pfizer Exclusivity

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