Background Information on Fluconazole (Diflucan)

Pfizer's Fluconazole Revenues (Gross)

1999 Fluconazole generated $1.002 billion (US) in global revenues. This represented about 1/16th of Pfizer's total revenues for all products in 1999. In the US, fluconazole generated $480 million in revenues; in international markets, fluconazole generated $522 million in revenues.
1998 Fluconazole generated $916 million (US) in global revenues. In the US, fluconazole generated $440 million in revenues; in international markets, fluconazole generated $476 million in revenues.

Current Indications

Source: Pfizer

Patent Information (USA)

Patent Number	Assignee	Date of Patent Filing	Date of Patent Approval	Patent Expiration
4416682	Imperial Chemical Industries PLC	Jun 2, 1981	Nov 22, 1983	Jun 02, 2001
4404216	Pfizer	Jun 1, 1982	Sep 13, 1983	Jan 29, 2004

Patent 4416682 was filed on June 2, 1981 and was approved on November 22, 1983. The inventor was Paul A Worthington from Maidenhead, Great Britain. US patent 4416682 was assigned to Imperial Chemical Industries PLC (London, GB2). Imperial Chemical Industries (ICI) sold their pharmaceutical division to AstraZeneca. According to the US FDA Orange Book, US patent 4416682 applies to the Diflucan formulation of fluconazole. ICI's specific claims to fluconazole involve the 2,4-dichloro analogue of fluconazole. In addition, ICI claims halogenated derivatives generically in US patent 4416682. Neither ICI or AstraZeneca manufacture fluconazole.

Patent 4404216 was filed on June 1, 1982 and was approved on September 13, 1983. Although US patent 4404216 was filed one year later than US patent 4416682, it was approved a little more than two months earlier. The inventor was Kenneth Richardson from Canterbury, Great Britain. US patent 4404216 was assigned to Pfizer Inc. (New York, NY). Although the US FDA Orange Book lists January 29, 2004 as the expiration of US patent 4404216, another source indicates that the Waxman-Hatch extension for US patent 4404216 pushed the expiry date to July 3, 2005.

Corrections or suggestions to Thiru Balasubramaniam thiru@cptech.org