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.
Summary for difluprednate
US Patents: | 0 |
Tradenames: | 2 |
Applicants: | 4 |
NDAs: | 4 |
Drug Master File Entries: | 4 |
Finished Product Suppliers / Packagers: | 5 |
Raw Ingredient (Bulk) Api Vendors: | 57 |
Clinical Trials: | 22 |
Patent Applications: | 7,091 |
Drug Prices: | Drug price trends for difluprednate |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for difluprednate |
What excipients (inactive ingredients) are in difluprednate? | difluprednate excipients list |
DailyMed Link: | difluprednate at DailyMed |
Recent Clinical Trials for difluprednate
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Kafrelsheikh University | Phase 4 |
Cathleen McCabe MD | Phase 4 |
Ocular Therapeutix, Inc. | Phase 4 |
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 |
Expired US Patents for difluprednate
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | DUREZOL | difluprednate | EMULSION;OPHTHALMIC | 022212-001 | Jun 23, 2008 | ⤷ Try a Trial | ⤷ Try a Trial |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |