FLUCONAZOLE - Generic Drug Details

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What are the generic sources for fluconazole and what is the scope of patent protection?

Fluconazole is the generic ingredient in eight branded drugs marketed by Pfizer, Aurobindo Pharma, Hainan Poly, Hikma, Ivax Sub Teva Pharms, Sun Pharm Inds Ltd, Taro Pharm Inds, Hikma Farmaceutica, Hospira, Norvium Bioscience, Woodward, Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, Baxter Hlthcare, Inforlife, Mylan Labs Ltd, West-ward Pharms Int, Ani Pharms, Chartwell, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Pharms Ltd, Lupin Ltd, Mylan Pharms Inc, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Thinq Pharm-cro Pvt, and Zydus Pharms, and is included in forty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for fluconazole. Forty-six suppliers are listed for this compound. There are five tentative approvals for this compound.

Summary for FLUCONAZOLE

US Patents:	0
Tradenames:	8
Applicants:	32
NDAs:	45
Drug Master File Entries:	23
Finished Product Suppliers / Packagers:	46
Raw Ingredient (Bulk) Api Vendors:	158
Clinical Trials:	274
Patent Applications:	7,103
Drug Prices:	Drug price trends 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

Drug Sales Revenue Trends for FLUCONAZOLE

See drug sales revenues for FLUCONAZOLE

Recent Clinical Trials for FLUCONAZOLE

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

Sponsor	Phase
Alexion Pharmaceuticals, Inc.	Phase 1
Huashan Hospital	Phase 4
FEMPHARMA Kft.	N/A

See all FLUCONAZOLE clinical trials

Generic filers with tentative approvals for FLUCONAZOLE

Applicant	Application No.	Strength	Dosage Form
⤷ Sign Up	⤷ Sign Up	200MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	150MG	TABLET;ORAL
⤷ Sign Up	⤷ Sign Up	100MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

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

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Glossary

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Thinq Pharm-cro Pvt	FLUCONAZOLE	fluconazole	TABLET;ORAL	076957-003	Sep 28, 2005	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Sun Pharm Inds Ltd	FLUCONAZOLE	fluconazole	FOR SUSPENSION;ORAL	076332-001	Jul 29, 2004		DISCN	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Chartwell	FLUCONAZOLE	fluconazole	TABLET;ORAL	076665-004	Jul 29, 2004	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
Zydus Pharms	FLUCONAZOLE	fluconazole	TABLET;ORAL	208963-004	Feb 16, 2017	AB	RX	No	No	⤷ Sign Up	⤷ Sign Up				⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>TE	>Type	>RLD	>RS	>Patent No.	>Patent Expiration	>Product	>Substance	>Delist Req.	>Exclusivity Expiration

Expired US Patents for FLUCONAZOLE

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Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-004	Jun 30, 1994	⤷ Sign Up	⤷ Sign Up
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-002	Jan 29, 1990	⤷ Sign Up	⤷ Sign Up
Pfizer	DIFLUCAN	fluconazole	TABLET;ORAL	019949-001	Jan 29, 1990	⤷ Sign Up	⤷ Sign Up
Pfizer	DIFLUCAN	fluconazole	FOR SUSPENSION;ORAL	020090-001	Dec 23, 1993	⤷ Sign Up	⤷ Sign Up
>Applicant	>Tradename	>Generic Name	>Dosage	>NDA	>Approval Date	>Patent No.	>Patent Expiration

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