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Last Updated: June 24, 2021

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Fluconazole - Generic Drug Details

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What are the generic drug sources for fluconazole and what is the scope of freedom to operate?

Fluconazole is the generic ingredient in eight branded drugs marketed by Pfizer, Aurobindo Pharma Ltd, Hikma, Ivax Sub Teva Pharms, Sun Pharm Inds Ltd, Taro Pharm Inds, Hikma Farmaceutica, Hospira, Mylan Labs Ltd, Woodward, Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, West-ward Pharms Int, Baxter Hlthcare, Inforlife, Ani Pharms Inc, Aurobindo Pharma, Chartwell, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Mylan, Mylan Pharms Inc, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Unique Pharm Labs, and Zydus Pharms, 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. Forty-one suppliers are listed for this compound. There are five tentative approvals for this compound.

Drug Prices for fluconazole

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Drug Sales Revenue Trends for fluconazole

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Recent Clinical Trials for fluconazole

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

SponsorPhase
George R ThompsonPhase 2
Mayne Pharma International Pty LtdPhase 2
Maastricht University Medical CenterPhase 4

See all fluconazole clinical trials

Generic filers with tentative approvals for FLUCONAZOLE
Applicant Application No. Strength Dosage Form
  Try Before You Buy  Try Before You Buy200MGTABLET;ORAL
  Try Before You Buy  Try Before You Buy150MGTABLET;ORAL
  Try Before You Buy  Try Before You Buy100MGTABLET;ORAL

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

Paragraph IV (Patent) Challenges for FLUCONAZOLE
Tradename Dosage Ingredient NDA Submissiondate
DIFLUCAN TABLET;ORAL fluconazole 019949
DIFLUCAN FOR SUSPENSION;ORAL fluconazole 020090

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
Ivax Sub Teva Pharms FLUCONAZOLE fluconazole FOR SUSPENSION;ORAL 077523-001 Sep 12, 2007 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Taro Pharm Inds FLUCONAZOLE fluconazole FOR SUSPENSION;ORAL 076918-001 Dec 18, 2006 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Chartwell FLUCONAZOLE fluconazole TABLET;ORAL 076665-004 Jul 29, 2004 AB RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Ranbaxy Labs Ltd FLUCONAZOLE fluconazole TABLET;ORAL 076386-004 Jul 29, 2004 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Baxter Hlthcare Corp FLUCONAZOLE IN SODIUM CHLORIDE 0.9% fluconazole INJECTABLE;INJECTION 077947-002 May 26, 2010 AP RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Hikma Farmaceutica FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 078764-001 Jan 30, 2012 DISCN No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Pfizer DIFLUCAN IN SODIUM CHLORIDE 0.9% fluconazole INJECTABLE;INJECTION 019950-006 Jan 29, 1990 DISCN Yes No   Try Before You Buy   Try Before You Buy   Try Before You Buy
>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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Serving leading biopharmaceutical companies globally:

Moodys
AstraZeneca
Harvard Business School
Express Scripts
Boehringer Ingelheim
Merck

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