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Fluconazole - Generic Drug Details

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What are the generic drug sources, and freedom to operate, for fluconazole?

Fluconazole is the generic ingredient in eight branded drugs marketed by Hospira, Acs Dobfar Info Sa, West-ward Pharms Int, Taro, Claris, Roxane, Taro Pharm Inds, Ivax Sub Teva Pharms, Harris Pharm, Pliva, Aurobindo Pharma, Sun Pharm Inds Ltd, Gedeon Richter Usa, Hikma Farmaceutica, Teva Pharms, Mylan Pharms Inc, Fresenius Kabi Usa, Pfizer, Aurobindo Pharma Ltd, Mylan, Teva Pharms Usa, Glenmark Generics, Unique Pharm Labs, Dr Reddys Labs Inc, Zydus Pharms Usa Inc, Apotex, Baxter Hlthcare, Teva, Idt Australia Ltd, Ranbaxy Labs Ltd, and Mylan Labs Ltd, and is included in forty-three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for fluconazole. Forty-eight suppliers are listed for this compound.

Summary for Generic Name: fluconazole

Tradenames:8
Patents:1
Applicants:31
NDAs:43
Drug Master File Entries: see list23
Suppliers / Packagers: see list48
Bulk Api Vendors: see list90
Clinical Trials: see list52
Patent Applications: see list5,629
Therapeutic Class:Antifungals
Formulation / Manufacturing:see details
Drug Prices:see low prices
DailyMed Link:fluconazole at DailyMed

Pharmacology for Ingredient: fluconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Apotex
FLUCONAZOLE
fluconazole
TABLET;ORAL076665-003Jul 29, 2004RXNoNo► Subscribe► Subscribe
Pliva
FLUCONAZOLE
fluconazole
TABLET;ORAL076424-001Jul 29, 2004DISCNNoNo► Subscribe► Subscribe
Unique Pharm Labs
FLUCONAZOLE
fluconazole
TABLET;ORAL076957-003Sep 28, 2005RXNoNo► Subscribe► Subscribe
Harris Pharm
FLUCONAZOLE
fluconazole
TABLET;ORAL078423-001Mar 7, 2011RXNoNo► Subscribe► Subscribe
Apotex
FLUCONAZOLE
fluconazole
TABLET;ORAL076665-002Jul 29, 2004RXNoNo► Subscribe► Subscribe
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Expired Orange Book Patents for Generic Ingredient: fluconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer
DIFLUCAN
fluconazole
FOR SUSPENSION;ORAL020090-001Dec 23, 19934,416,682► Subscribe
Pfizer
DIFLUCAN IN SODIUM CHLORIDE 0.9%
fluconazole
INJECTABLE;INJECTION019950-001Jan 29, 19904,416,682► Subscribe
Pfizer
DIFLUCAN
fluconazole
TABLET;ORAL019949-001Jan 29, 19904,404,216*PED► Subscribe
Pfizer
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
fluconazole
INJECTABLE;INJECTION019950-005Jul 8, 19944,404,216*PED► Subscribe
Pfizer
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
fluconazole
INJECTABLE;INJECTION019950-002Jan 29, 19904,404,216*PED► Subscribe
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.

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