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Last Updated: October 31, 2020

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Fluconazole - Generic Drug Details

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What are the generic 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
Hospices Civils de LyonPhase 3
Kafrelsheikh UniversityPhase 2
BeiGenePhase 1

See all fluconazole clinical trials

Generic filers with tentative approvals for FLUCONAZOLE
Applicant Application No. Strength Dosage Form
  Start Trial  Start Trial200MGTABLET;ORAL
  Start Trial  Start Trial150MGTABLET;ORAL
  Start Trial  Start Trial100MGTABLET;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
Ranbaxy Labs Ltd FLUCONAZOLE fluconazole TABLET;ORAL 076386-004 Jul 29, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Taro Pharm Inds FLUCONAZOLE fluconazole FOR SUSPENSION;ORAL 076918-001 Dec 18, 2006 DISCN No No   Start Trial   Start Trial   Start Trial
West-ward Pharms Int FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 078107-001 Jul 30, 2008 AP RX No No   Start Trial   Start Trial   Start Trial
Roxane FLUCONAZOLE fluconazole TABLET;ORAL 076213-004 Jul 29, 2004 DISCN No No   Start Trial   Start Trial   Start Trial
Woodward FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 077909-003 Apr 20, 2015 RX No No   Start Trial   Start Trial   Start Trial
Pfizer DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 019950-004 Jan 29, 1990 DISCN Yes No   Start Trial   Start Trial   Start Trial
>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

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer DIFLUCAN fluconazole FOR SUSPENSION;ORAL 020090-002 Dec 23, 1993   Start Trial   Start Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-001 Jan 29, 1990   Start Trial   Start Trial
Pfizer DIFLUCAN fluconazole FOR SUSPENSION;ORAL 020090-001 Dec 23, 1993   Start Trial   Start Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-003 Jan 29, 1990   Start Trial   Start Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-004 Jun 30, 1994   Start Trial   Start Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-001 Jan 29, 1990   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
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Medtronic
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Express Scripts

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