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Last Updated: October 23, 2021

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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 Pharms, 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, 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-five 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
Karolinska InstitutetPhase 2
Vedic Lifesciences Pvt. Ltd.Phase 4
University of ManitobaEarly Phase 1

See all fluconazole clinical trials

Generic filers with tentative approvals for FLUCONAZOLE
Applicant Application No. Strength Dosage Form
⤷  Try it Free⤷  Try it Free200MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free150MGTABLET;ORAL
⤷  Try it Free⤷  Try it Free100MGTABLET;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
Hikma Pharms FLUCONAZOLE IN SODIUM CHLORIDE 0.9% fluconazole INJECTABLE;INJECTION 076087-003 Jul 29, 2004 AP RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Hospira FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 076304-002 Jul 29, 2004 DISCN No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
Ivax Sub Teva Pharms FLUCONAZOLE fluconazole TABLET;ORAL 076077-002 Jul 29, 2004 AB RX No No ⤷  Try it Free ⤷  Try it Free ⤷  Try it Free
>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 IN DEXTROSE 5% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 019950-003 Sep 29, 1992 ⤷  Try it Free ⤷  Try it Free
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-003 Jan 29, 1990 ⤷  Try it Free ⤷  Try it Free
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-004 Jun 30, 1994 ⤷  Try it Free ⤷  Try it Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Serving leading biopharmaceutical companies globally:

McKinsey
Moodys
Medtronic
Baxter
Dow
Express Scripts

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