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Last Updated: July 4, 2020

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DIFLUCAN Drug Profile


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Which patents cover Diflucan, and when can generic versions of Diflucan launch?

Diflucan is a drug marketed by Pfizer and is included in three NDAs.

The generic ingredient in DIFLUCAN 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.

US ANDA Litigation and Generic Entry Outlook for Diflucan

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

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Drug patent expirations by year for DIFLUCAN
Drug Prices for DIFLUCAN

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Drug Sales Revenue Trends for DIFLUCAN

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Recent Clinical Trials for DIFLUCAN

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
St. Antonius HospitalPhase 4
Radboud UniversityPhase 4
Altasciences Company Inc.Phase 1

See all DIFLUCAN clinical trials

Paragraph IV (Patent) Challenges for DIFLUCAN
Tradename Dosage Ingredient NDA Submissiondate
DIFLUCAN TABLET;ORAL fluconazole 019949
DIFLUCAN FOR SUSPENSION;ORAL fluconazole 020090

US Patents and Regulatory Information for DIFLUCAN

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pfizer DIFLUCAN fluconazole FOR SUSPENSION;ORAL 020090-001 Dec 23, 1993 AB RX Yes No   Start Trial   Start Trial   Start Trial
Pfizer DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER fluconazole INJECTABLE;INJECTION 019950-003 Sep 29, 1992 DISCN Yes No   Start Trial   Start Trial   Start Trial
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-002 Jan 29, 1990 AB RX Yes 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 DIFLUCAN

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Pfizer DIFLUCAN fluconazole TABLET;ORAL 019949-001 Jan 29, 1990   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 019949-002 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:

Dow
Moodys
Mallinckrodt
Johnson and Johnson
Baxter
McKesson

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