DUREZOL Drug Patent Profile
✉ Email this page to a colleague
Which patents cover Durezol, and when can generic versions of Durezol launch?
Durezol is a drug marketed by Sandoz and is included in one NDA.
The generic ingredient in DUREZOL 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 Durezol
A generic version of DUREZOL was approved as difluprednate by CIPLA on August 9th, 2021.
AI Research Assistant
Questions you can ask:
- What is the 5 year forecast for DUREZOL?
- What are the global sales for DUREZOL?
- What is Average Wholesale Price for DUREZOL?
Summary for DUREZOL
US Patents: | 0 |
Applicants: | 1 |
NDAs: | 1 |
Finished Product Suppliers / Packagers: | 2 |
Raw Ingredient (Bulk) Api Vendors: | 57 |
Clinical Trials: | 6 |
Patent Applications: | 6,725 |
Drug Prices: | Drug price information 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 |
![DUREZOL drug patent expirations Drug patent expirations by year for DUREZOL](/p/graph/s/t/DUREZOL-patent-expirations.png)
![Drug Prices for DUREZOL](/p/graph/drug-price/DUREZOL.png)
![Drug Sales Revenue Trends for DUREZOL](/p/graph/drug-sales-revenues/DUREZOL.png)
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 |
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 |
---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Sandoz | DUREZOL | difluprednate | EMULSION;OPHTHALMIC | 022212-001 | Jun 23, 2008 | AB | RX | Yes | Yes | ⤷ 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 |
Expired US Patents for DUREZOL
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Sandoz | DUREZOL | difluprednate | EMULSION;OPHTHALMIC | 022212-001 | Jun 23, 2008 | ⤷ Sign Up | ⤷ Sign Up |
>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 |
---|---|---|---|
Japan | H1129483 | COMPOSITION CONTAINING DIFLUPREDNATE | ⤷ Sign Up |
Japan | 3410364 | ⤷ Sign Up | |
European Patent Office | 0878197 | Compositions à base de difluprednate (Compositions containing difluprednate) | ⤷ Sign Up |
China | 1200926 | ⤷ Sign Up | |
Germany | 69807281 | ⤷ Sign Up | |
Canada | 2237503 | ⤷ Sign Up | |
>Country | >Patent Number | >Title | >Estimated Expiration |