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Last Updated: January 27, 2023

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, 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, Baxter Hlthcare, Inforlife, West-ward Pharms Int, Ani Pharms, Chartwell, Dr Reddys Labs Inc, Gedeon Richter Usa, Glenmark Generics, Mylan, Mylan Pharms Inc, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Thinq Pharm-cro Pvt, 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. Thirty-nine 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
CTI BioPharmaPhase 1
PPDPhase 1
Peking Union Medical College HospitalN/A

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Generic filers with tentative approvals for FLUCONAZOLE
Applicant Application No. Strength Dosage Form
See Plans and PricingSee Plans and Pricing100MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing50MGTABLET;ORAL
See Plans and PricingSee Plans and Pricing200MGTABLET;ORAL

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

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
Baxter Hlthcare Corp FLUCONAZOLE IN SODIUM CHLORIDE 0.9% fluconazole INJECTABLE;INJECTION 077947-001 May 26, 2010 AP RX No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-004 Jun 30, 1994 AB RX Yes No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Pliva FLUCONAZOLE fluconazole TABLET;ORAL 076424-001 Jul 29, 2004 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
Teva FLUCONAZOLE fluconazole TABLET;ORAL 074681-002 Jul 29, 2004 DISCN No No See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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 TABLET;ORAL 019949-001 Jan 29, 1990 See Plans and Pricing See Plans and Pricing
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-004 Jun 30, 1994 See Plans and Pricing See Plans and Pricing
Pfizer DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 019950-004 Jan 29, 1990 See Plans and Pricing See Plans and Pricing
Pfizer DIFLUCAN fluconazole FOR SUSPENSION;ORAL 020090-001 Dec 23, 1993 See Plans and Pricing See Plans and Pricing
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

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Medtronic
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Express Scripts

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 verification 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.