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Last Updated: May 26, 2022

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 Novartis and is included in one NDA.

The generic ingredient in DUREZOL is difluprednate. There are four drug master file entries for this compound. Four suppliers are 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

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

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

See all DUREZOL clinical trials

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
Novartis DUREZOL difluprednate EMULSION;OPHTHALMIC 022212-001 Jun 23, 2008 AB RX Yes Yes See Plans and Pricing See Plans and Pricing See Plans and Pricing
>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
European Patent Office 0878197 Compositions à base de difluprednate (Compositions containing difluprednate) See Plans and Pricing
Canada 2237503 See Plans and Pricing
Germany 69807281 See Plans and Pricing
Japan H1129483 COMPOSITION CONTAINING DIFLUPREDNATE See Plans and Pricing
Japan 3410364 See Plans and Pricing
China 1200926 See Plans and Pricing
>Country >Patent Number >Title >Estimated Expiration

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Serving leading biopharmaceutical companies globally:

Johnson and Johnson
Medtronic
AstraZeneca
Harvard Business School
Merck
Baxter

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.