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Serving leading biopharmaceutical companies globally:

Boehringer Ingelheim
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Covington
Healthtrust
Dow
Novartis
UBS
Cantor Fitzgerald
Argus Health
Fish and Richardson

Generated: February 18, 2018

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 Pfizer, Aurobindo Pharma Ltd, Ivax Sub Teva Pharms, Sun Pharm Inds Ltd, Taro Pharm Inds, West-ward Pharms Int, Hikma Farmaceutica, Hospira, Mylan Labs Ltd, Renaissance Ssa Llc, Baxter Hlthcare Corp, Fresenius Kabi Usa, Teva Pharms Usa, Baxter Hlthcare, Inforlife, Teva Pharms, Apotex, Aurobindo Pharma, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Harris Pharm, Idt Australia Ltd, Mylan, Mylan Pharms Inc, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Unique Pharm Labs, and Zydus Pharms Usa Inc, 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-one suppliers are listed for this compound. There are six tentative approvals for this compound.
Tentative approvals for FLUCONAZOLE
Applicant Application No. Strength Dosage Form
➤ Try a Free Trial➤ Try a Free Trial50MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial200MGTABLET;ORAL
➤ Try a Free Trial➤ Try a Free Trial150MGTABLET;ORAL

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
Gedeon Richter Usa FLUCONAZOLE fluconazole TABLET;ORAL 076432-003 Jul 29, 2004 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Mylan FLUCONAZOLE fluconazole TABLET;ORAL 076351-003 Jul 29, 2004 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Inforlife FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 079104-002 Jul 30, 2009 AP RX No Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Zydus Pharms Usa Inc FLUCONAZOLE fluconazole TABLET;ORAL 208963-003 Feb 16, 2017 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-003 Jan 29, 1990 AB RX Yes Yes ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Ranbaxy Labs Ltd FLUCONAZOLE fluconazole TABLET;ORAL 076386-003 Jul 29, 2004 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Taro FLUCONAZOLE fluconazole TABLET;ORAL 076507-002 Jul 29, 2004 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Apotex FLUCONAZOLE fluconazole TABLET;ORAL 076665-001 Jul 29, 2004 AB RX No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Roxane FLUCONAZOLE fluconazole TABLET;ORAL 076213-002 Jul 29, 2004 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Idt Australia Ltd FLUCONAZOLE fluconazole TABLET;ORAL 076086-001 Jul 29, 2004 DISCN No No ➤ Try a Free Trial ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration

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Expired US Patents for fluconazole

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer DIFLUCAN fluconazole FOR SUSPENSION;ORAL 020090-002 Dec 23, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-001 Jan 29, 1990 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-001 Jan 29, 1990 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-004 Jun 30, 1994 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-003 Jan 29, 1990 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 019950-004 Jan 29, 1990 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer DIFLUCAN fluconazole FOR SUSPENSION;ORAL 020090-001 Dec 23, 1993 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-002 Jan 29, 1990 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-003 Jan 29, 1990 ➤ Try a Free Trial ➤ Try a Free Trial
Pfizer DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 019950-002 Jan 29, 1990 ➤ Try a Free Trial ➤ Try a Free Trial
Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration

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Serving hundreds of leading biopharmaceutical companies globally:

Moodys
Fuji
Cantor Fitzgerald
Harvard Business School
Chinese Patent Office
Colorcon
Federal Trade Commission
Fish and Richardson
Citi

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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