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Last Updated: March 29, 2024

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 two branded drugs marketed by Amneal, Cipla, Dr Reddys, and Sandoz, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for difluprednate. Five suppliers are listed for this compound.

Drug Prices for difluprednate

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Recent Clinical Trials for difluprednate

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

SponsorPhase
Kafrelsheikh UniversityPhase 4
Cathleen McCabe MDPhase 4
Ocular Therapeutix, Inc.Phase 4

See all difluprednate clinical trials

Paragraph IV (Patent) Challenges for DIFLUPREDNATE
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 difluprednate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Amneal DIFLUPREDNATE difluprednate EMULSION;OPHTHALMIC 211526-001 Nov 17, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Sandoz DUREZOL difluprednate EMULSION;OPHTHALMIC 022212-001 Jun 23, 2008 AB RX Yes Yes ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a Trial
Cipla DIFLUPREDNATE difluprednate EMULSION;OPHTHALMIC 211776-001 Aug 9, 2021 AB RX No No ⤷  Try a Trial ⤷  Try a Trial ⤷  Try a 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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