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Last Updated: March 4, 2021

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DUREZOL Drug Profile

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

Durezol is a drug marketed by Novartis and is included in one NDA.

The generic ingredient in DUREZOL is difluprednate. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the difluprednate profile page.

Drug patent expirations by year for DUREZOL
Drug Prices for DUREZOL

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Drug Sales Revenue Trends for DUREZOL

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Recent Clinical Trials for DUREZOL

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SponsorPhase
Ocular Therapeutix, Inc.Phase 4
Cathleen McCabe MDPhase 4
University of California, San FranciscoPhase 4

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Paragraph IV (Patent) Challenges for DUREZOL
Tradename Dosage Ingredient NDA Submissiondate
DUREZOL EMULSION;OPHTHALMIC difluprednate 022212 2014-05-01

US Patents and Regulatory Information for DUREZOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Novartis DUREZOL difluprednate EMULSION;OPHTHALMIC 022212-001 Jun 23, 2008 RX Yes Yes   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

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