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Last Updated: August 14, 2020

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Difluprednate - Generic Drug Details

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What are the generic sources for difluprednate and what is the scope of patent protection?

Difluprednate is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for difluprednate. One supplier is listed for this compound.

Recent Clinical Trials for difluprednate

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

Ocular TherapeutixPhase 4
New England Retina AssociatesPhase 4
Kaiser PermanentePhase 4

See all difluprednate clinical trials

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

US Patents and Regulatory Information for difluprednate

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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Harvard Business School
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