DUREZOL Drug Patent Profile
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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 |
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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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Friedman, Yali. "DrugPatentWatch" DrugPatentWatch, thinkBiotech, 2023, www.DrugPatentWatch.com.
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