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Last Updated: June 24, 2024

DUREZOL Drug Patent Profile

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

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

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

DrugPatentWatch® Litigation and Generic Entry Outlook for Durezol

A generic version of DUREZOL was approved as difluprednate by CIPLA on August 9th, 2021.

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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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Cathleen McCabe MDPhase 4
Ocular Therapeutix, Inc.Phase 4
Aravind Eye Hospitals, IndiaPhase 4

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Paragraph IV (Patent) Challenges for DUREZOL
Tradename Dosage Ingredient Strength NDA ANDAs Submitted Submissiondate
DUREZOL Ophthalmic Emulsion difluprednate 0.05% 022212 1 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
Sandoz DUREZOL difluprednate EMULSION;OPHTHALMIC 022212-001 Jun 23, 2008 AB RX Yes Yes ⤷  Sign Up ⤷  Sign Up ⤷  Sign Up
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

International Patents for DUREZOL

See the table below for patents covering DUREZOL around the world.

Country Patent Number Title Estimated Expiration
Japan 3410364 ⤷  Sign Up
China 1200926 ⤷  Sign Up
European Patent Office 0878197 Compositions à base de difluprednate (Compositions containing difluprednate) ⤷  Sign Up
Germany 69807281 ⤷  Sign Up
Canada 2237503 ⤷  Sign Up
>Country >Patent Number >Title >Estimated Expiration

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