DUREZOL Drug Patent Profile
✉ Email this page to a colleague
▶ Start for $1
Remove trial restrictions
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. Seven suppliers are listed for this compound. Additional details are available on the difluprednate profile page.
DrugPatentWatch® Litigation and Generic Entry Outlook for Durezol
A generic version of DUREZOL was approved as difluprednate by CIPLA on August 9th, 2021.
Summary for DUREZOL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 3 |
Raw Ingredient (Bulk) Api Vendors: | 57 |
Clinical Trials: | 6 |
Patent Applications: | 5,332 |
Drug Prices: | Drug price information for DUREZOL |
Drug Sales Revenues: | Drug sales revenues for DUREZOL |
Patent Litigation and PTAB cases: | See patent lawsuits and PTAB cases for DUREZOL |
What excipients (inactive ingredients) are in DUREZOL? | DUREZOL excipients list |
DailyMed Link: | DUREZOL at DailyMed |



Recent Clinical Trials for DUREZOL
Identify potential brand extensions & 505(b)(2) entrants
Sponsor | Phase |
---|---|
Cathleen McCabe MD | Phase 4 |
Ocular Therapeutix, Inc. | Phase 4 |
University of California, San Francisco | Phase 4 |
Anatomical Therapeutic Chemical (ATC) Classes for DUREZOL
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 | ⤷ 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 DUREZOL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Novartis | 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 |
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) | ⤷ Try a Trial |
Germany | 69807281 | ⤷ Try a Trial | |
Japan | H1129483 | COMPOSITION CONTAINING DIFLUPREDNATE | ⤷ Try a Trial |
>Country | >Patent Number | >Title | >Estimated Expiration |