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Last Updated: June 22, 2021

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FLUCONAZOLE Drug Profile


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Which patents cover Fluconazole, and what generic alternatives are available?

Fluconazole is a drug marketed by Aurobindo Pharma Ltd, Hikma, Ivax Sub Teva Pharms, Sun Pharm Inds Ltd, Taro Pharm Inds, 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, Zydus Pharms, Hikma Farmaceutica, Hospira, Mylan Labs Ltd, Woodward, Baxter Hlthcare Corp, Dr Reddys, Fresenius Kabi Usa, West-ward Pharms Int, Baxter Hlthcare, and Inforlife. and is included in forty NDAs.

The generic ingredient in FLUCONAZOLE is fluconazole. There are twenty-three drug master file entries for this compound. Forty suppliers are listed for this compound. Additional details are available on the fluconazole profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Fluconazole

A generic version of FLUCONAZOLE was approved as fluconazole by CHARTWELL on July 29th, 2004.

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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
Unique Pharm Labs FLUCONAZOLE fluconazole TABLET;ORAL 076957-002 Sep 28, 2005 AB RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Hikma Farmaceutica FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 078698-001 Jan 30, 2012 AP RX No No   Try Before You Buy   Try Before You Buy   Try Before You Buy
Ivax Sub Teva Pharms FLUCONAZOLE fluconazole TABLET;ORAL 076077-003 Jul 29, 2004 AB RX No 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

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