DIFLUCAN Drug Patent Profile

Which patents cover Diflucan, and when can generic versions of Diflucan launch?

Diflucan is a drug marketed by Pfizer and is included in three NDAs.

The generic ingredient in DIFLUCAN is fluconazole. There are twenty-three drug master file entries for this compound. Forty-six suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Diflucan

A generic version of DIFLUCAN was approved as fluconazole by CHARTWELL on July 29^th, 2004.

Summary for DIFLUCAN

US Patents:	0
Applicants:	1
NDAs:	3
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	157
Clinical Trials:	40
Patent Applications:	4,202
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DIFLUCAN
Drug Sales Revenues:	Drug sales revenues for DIFLUCAN
What excipients (inactive ingredients) are in DIFLUCAN?	DIFLUCAN excipients list
DailyMed Link:	DIFLUCAN at DailyMed

See drug prices for DIFLUCAN

See drug sales revenues for DIFLUCAN

Recent Clinical Trials for DIFLUCAN

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
Peking Union Medical College Hospital	N/A
CSPC Ouyi Pharmaceutical Group Co., Ltd.	N/A
Maastricht University Medical Center	Phase 3

See all DIFLUCAN clinical trials

Pharmacology for DIFLUCAN

Drug Class	Azole Antifungal
Mechanism of Action	Cytochrome P450 2C19 Inhibitors Cytochrome P450 2C9 Inhibitors Cytochrome P450 3A4 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for DIFLUCAN

D01AC	Imidazole and triazole derivatives
D01A	ANTIFUNGALS FOR TOPICAL USE
D01	ANTIFUNGALS FOR DERMATOLOGICAL USE
D	Dermatologicals

J02AC	Triazole and tetrazole derivatives
J02A	ANTIMYCOTICS FOR SYSTEMIC USE
J02	ANTIMYCOTICS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for DIFLUCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Pfizer	DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090-001	Dec 23, 1993	AB	RX	Yes	No
Pfizer	DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	019950-003	Sep 29, 1992		DISCN	Yes	No
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-002	Jan 29, 1990	AB	RX	Yes	No

Expired US Patents for DIFLUCAN

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-004	Jun 30, 1994
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-002	Jan 29, 1990
Pfizer	DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090-002	Dec 23, 1993

International Patents for DIFLUCAN

See the table below for patents covering DIFLUCAN around the world.

Country	Patent Number	Title	Estimated Expiration
Norway	156128
United Kingdom	2099818
Spain	8404348