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Last Updated: March 29, 2024

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, Hainan Poly, 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, Lupin Ltd, Mylan, Mylan Pharms Inc, Pliva, Ranbaxy Labs Ltd, Roxane, Taro, Teva, Thinq Pharm-cro Pvt, and Zydus Pharms, and is included in forty-five NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-three drug master file entries for fluconazole. Forty-six 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
FEMPHARMA Kft.N/A
PPDPhase 1
Rehab WeridaN/A

See all fluconazole clinical trials

Generic filers with tentative approvals for FLUCONAZOLE
Applicant Application No. Strength Dosage Form
⤷  Try a Trial⤷  Try a Trial200MGTABLET;ORAL
⤷  Try a Trial⤷  Try a Trial150MGTABLET;ORAL
⤷  Try a Trial⤷  Try a 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.

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
Pfizer DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 019950-003 Sep 29, 1992 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Fresenius Kabi Usa FLUCONAZOLE IN SODIUM CHLORIDE 0.9% fluconazole INJECTABLE;INJECTION 076145-002 Jul 29, 2004 AP RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Pfizer DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 019950-004 Jan 29, 1990 DISCN Yes No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Glenmark Generics FLUCONAZOLE fluconazole TABLET;ORAL 077253-002 Jan 25, 2006 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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 TABLET;ORAL 019949-004 Jun 30, 1994 ⤷  Try a Trial ⤷  Try a Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-001 Jan 29, 1990 ⤷  Try a Trial ⤷  Try a Trial
Pfizer DIFLUCAN fluconazole FOR SUSPENSION;ORAL 020090-001 Dec 23, 1993 ⤷  Try a Trial ⤷  Try a Trial
Pfizer DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 019950-004 Jan 29, 1990 ⤷  Try a Trial ⤷  Try a Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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