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Serving leading biopharmaceutical companies globally:

US Army
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Generated: November 21, 2017

DrugPatentWatch Database Preview

Fluconazole - Generic Drug Details

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

Fluconazole
is the generic ingredient in eight branded drugs marketed by Hospira, Acs Dobfar Info Sa, West-ward Pharms Int, Taro, Renaissance Ssa Llc, 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, Baxter Hlthcare Corp, 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. Additional information is available in the individual branded drug profile pages.

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

Tentative approvals for FLUCONAZOLE

Applicant Application No. Strength Dosage Form
u► Subscribe50MGTABLET;ORAL
u► Subscribe200MGTABLET;ORAL
u► Subscribe150MGTABLET;ORAL
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hospira
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
fluconazole
INJECTABLE;INJECTION076617-001Jul 29, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
Idt Australia Ltd
FLUCONAZOLE
fluconazole
TABLET;ORAL076086-004Jul 29, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
Zydus Pharms Usa Inc
FLUCONAZOLE
fluconazole
TABLET;ORAL208963-001Feb 16, 2017ABRXNoNo► Subscribe► Subscribe► Subscribe
Ivax Sub Teva Pharms
FLUCONAZOLE
fluconazole
TABLET;ORAL076077-001Jul 29, 2004ABRXNoNo► Subscribe► Subscribe► Subscribe
Teva Pharms
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
fluconazole
INJECTABLE;INJECTION076837-001Jan 13, 2005DISCNNoNo► Subscribe► Subscribe► Subscribe
Pliva
FLUCONAZOLE
fluconazole
TABLET;ORAL076424-001Jul 29, 2004DISCNNoNo► Subscribe► Subscribe► Subscribe
Pfizer
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
fluconazole
INJECTABLE;INJECTION019950-005Jul 8, 1994DISCNYesNo► Subscribe► Subscribe► Subscribe
Pfizer
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
fluconazole
INJECTABLE;INJECTION019950-002Jan 29, 1990DISCNYesNo► Subscribe► Subscribe► Subscribe
Pfizer
DIFLUCAN
fluconazole
TABLET;ORAL019949-002Jan 29, 1990ABRXYesNo► Subscribe► Subscribe► Subscribe
Idt Australia Ltd
FLUCONAZOLE
fluconazole
TABLET;ORAL076086-003Jul 29, 2004DISCNNoNo► Subscribe► 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, 1993► Subscribe► Subscribe
Pfizer
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
fluconazole
INJECTABLE;INJECTION019950-002Jan 29, 1990► Subscribe► Subscribe
Pfizer
DIFLUCAN IN SODIUM CHLORIDE 0.9%
fluconazole
INJECTABLE;INJECTION019950-001Jan 29, 1990► Subscribe► Subscribe
Pfizer
DIFLUCAN
fluconazole
TABLET;ORAL019949-001Jan 29, 1990► Subscribe► Subscribe
Pfizer
DIFLUCAN
fluconazole
TABLET;ORAL019949-002Jan 29, 1990► Subscribe► Subscribe
Pfizer
DIFLUCAN
fluconazole
TABLET;ORAL019949-004Jun 30, 1994► Subscribe► Subscribe
Pfizer
DIFLUCAN
fluconazole
TABLET;ORAL019949-003Jan 29, 1990► Subscribe► Subscribe
Pfizer
DIFLUCAN
fluconazole
TABLET;ORAL019949-003Jan 29, 1990► Subscribe► Subscribe
Pfizer
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
fluconazole
INJECTABLE;INJECTION019950-003Sep 29, 1992► Subscribe► Subscribe
Pfizer
DIFLUCAN
fluconazole
FOR SUSPENSION;ORAL020090-002Dec 23, 1993► Subscribe► Subscribe
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Serving leading biopharmaceutical companies globally:

Cantor Fitzgerald
AstraZeneca
Johnson and Johnson
Healthtrust
Colorcon
Boehringer Ingelheim
US Department of Justice
Farmers Insurance
Moodys
Cerilliant

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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