DIFLUPREDNATE Drug Patent Profile
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When do Difluprednate patents expire, and when can generic versions of Difluprednate launch?
Difluprednate is a drug marketed by Amneal, Cipla, and Dr Reddys. and is included in three NDAs.
The generic ingredient in DIFLUPREDNATE 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 Difluprednate
A generic version of DIFLUPREDNATE was approved as difluprednate by CIPLA on August 9th, 2021.
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Summary for DIFLUPREDNATE
Recent Clinical Trials for DIFLUPREDNATE
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Kafrelsheikh University | Phase 4 |
Ocular Therapeutix, Inc. | Phase 4 |
Cathleen McCabe MD | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for DIFLUPREDNATE
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 | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Cipla | DIFLUPREDNATE | difluprednate | EMULSION;OPHTHALMIC | 211776-001 | Aug 9, 2021 | AB | RX | No | No | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | |||
Dr Reddys | DIFLUPREDNATE | difluprednate | EMULSION;OPHTHALMIC | 214894-001 | Nov 16, 2022 | AB | RX | No | No | ⤷ 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 |