FLUCONAZOLE Drug Patent Profile

Which patents cover Fluconazole, and what generic alternatives are available?

Fluconazole is a drug marketed by Aurobindo Pharma, Hainan Poly, Hikma, Ivax Sub Teva Pharms, Sun Pharm Inds Ltd, Taro Pharm Inds, Ani Pharms, Chartwell, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Lupin Ltd, Mylan, Mylan Pharms Inc, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Thinq Pharm-cro Pvt, Zydus Pharms, Hikma Farmaceutica, Hospira, Mylan Labs Ltd, Woodward, Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Baxter Hlthcare, Inforlife, and West-ward Pharms Int. and is included in forty-two NDAs.

The generic ingredient in FLUCONAZOLE 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 Fluconazole

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

Summary for FLUCONAZOLE

US Patents:	0
Applicants:	31
NDAs:	42
Finished Product Suppliers / Packagers:	39
Raw Ingredient (Bulk) Api Vendors:	158
Clinical Trials:	272
Patent Applications:	4,254
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for FLUCONAZOLE
Drug Sales Revenues:	Drug sales revenues for FLUCONAZOLE
What excipients (inactive ingredients) are in FLUCONAZOLE?	FLUCONAZOLE excipients list
DailyMed Link:	FLUCONAZOLE at DailyMed

See drug prices for FLUCONAZOLE

See drug sales revenues for FLUCONAZOLE

Recent Clinical Trials for FLUCONAZOLE

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

Sponsor	Phase
FEMPHARMA Kft.	N/A
Rehab Werida	N/A
CTI BioPharma	Phase 1

See all FLUCONAZOLE clinical trials

Pharmacology for FLUCONAZOLE

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

Medical Subject Heading (MeSH) Categories for FLUCONAZOLE

14-alpha Demethylase Inhibitors

Antifungal Agents

Cytochrome P-450 CYP2C19 Inhibitors

Cytochrome P-450 CYP2C9 Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for FLUCONAZOLE

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 FLUCONAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva	FLUCONAZOLE	fluconazole	TABLET;ORAL	074681-001	Jul 29, 2004		DISCN	No	No
Hikma Farmaceutica	FLUCONAZOLE IN SODIUM CHLORIDE 0.9%	fluconazole	INJECTABLE;INJECTION	076736-001	Aug 23, 2005	AP	RX	No	No
Ivax Sub Teva Pharms	FLUCONAZOLE	fluconazole	TABLET;ORAL	076077-002	Jul 29, 2004		DISCN	No	No
Gedeon Richter Usa	FLUCONAZOLE	fluconazole	TABLET;ORAL	076432-001	Jul 29, 2004		DISCN	No	No
Hospira	FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	076304-001	Jul 29, 2004		DISCN	No	No
Mylan Labs Ltd	FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER	fluconazole	INJECTABLE;INJECTION	076889-001	Mar 25, 2005		DISCN	No	No
Mylan	FLUCONAZOLE	fluconazole	TABLET;ORAL	076351-002	Jul 29, 2004		DISCN	No	No