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DUREZOL Drug Profile
» See Plans and Pricing
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. One supplier is listed for this compound. Additional details are available on the difluprednate profile page.
Summary for DUREZOL
| US Patents: | 0 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 43 |
| Clinical Trials: | 6 |
| Patent Applications: | 4,117 |
| 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 |
|---|---|
| Ocular Therapeutix, Inc. | Phase 4 |
| Cathleen McCabe MD | Phase 4 |
| University of California, San Francisco | Phase 4 |
Paragraph IV (Patent) Challenges for DUREZOL
| Tradename | Dosage | Ingredient | NDA | Submissiondate |
|---|---|---|---|---|
| DUREZOL | EMULSION;OPHTHALMIC | difluprednate | 022212 | 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 | 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 |
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 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
International Patents for DUREZOL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| China | 1200926 | Start Trial |
| Canada | 2237503 | Start Trial |
| Japan | 3410364 | Start Trial |
| European Patent Office | 0878197 | Start Trial |
| Japan | H1129483 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
