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DUREZOL Drug Profile
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» See Plans and PricingWhich 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
Recent Clinical Trials for DUREZOL
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| University of California, San Francisco | Phase 4 |
| Alcon Research | Phase 2 |
| Alcon Research | Phase 3 |
Recent Litigation for DUREZOL
Identify potential future generic entrants
PTAB Litigation
| Petitioner | Date |
|---|---|
| Akorn, Inc. | 2015-05-15 |
Synonyms for DUREZOL
| (1R,2S,8S,10S,11S,14R,15S,17S)-14-[2-(acetyloxy)acetyl]-1,8-difluoro-17-hydroxy-2,15-dimethyl-5-oxotetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-3,6-dien-14-yl butanoate |
| (6alpha,11beta)-21-(Acetyloxy)-6,9-difluoro-11-hydroxy-17-(1-oxobutoxy)pregna-1,4-diene-3,20-dion |
| (6S,8S,9R,10S,11S,13S,14S,17R)-17-(2-acetoxyacetyl)-6,9-difluoro-11-hydroxy-10,13-dimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthren-17-yl butyrate |
| [(6S,8S,9R,10S,11S,13S,14S,17R)-17-(2-acetyloxyacetyl)-6,9-difluoro-11-hydroxy-10,13-dimethyl-3-oxo-6,7,8,11,12,14,15,16-octahydrocyclopenta[a]phenanthren-17-yl] butanoate |
| 21-(Acetyloxy)-6,9-difluoro-11-hydroxy-17-(1-oxobutoxy)pregna-1,4-diene-3,20-dione (6alpha,11beta)- |
| 23674-86-4 |
| 6-alpha,9-alpha-Difluoroprednisolone 17-butyrate 21-acetate |
| 6|A,9|A-Difluoroprednisolone 21-acetate 17-butyrate |
| 674D864 |
| 6alpha-9-Difluoroprednisolone 21-acetate 17-butyrate |
| 6alpha,9-Difluoro-11beta,17,21-trihydroxypregna-1,4-diene-3,20-dione 21-acetate 17-butyrate |
| 6ALPHA,9ALPHA-DIFLUOROPREDNISOLONE 21-ACETATE 17-BUTYRATE |
| 6alpha,9alpha-Difluoroprednisolone 21-acetate 17-butyrate, >=98% |
| AB00383058_10 |
| AB2000742 |
| ACT03289 |
| AS-15800 |
| C12695 |
| C27H34F2O7 |
| CAS-23674-86-4 |
| CHEBI:31485 |
| CHEMBL1201749 |
| CM 9155 |
| CS-3001 |
| D01266 |
| DB06781 |
| DFBA |
| Difluoroprednisolone butyrate acetate |
| difluprednate |
| Difluprednate (JAN/USAN/INN) |
| Difluprednate [USAN:INN:JAN] |
| Difluprednato |
| Difluprednato [INN-Spanish] |
| Difluprednatum |
| Difluprednatum [INN-Latin] |
| DSSTox_CID_26773 |
| DSSTox_GSID_46773 |
| DSSTox_RID_81894 |
| DTXSID0046773 |
| Durezol (TN) |
| EINECS 245-815-4 |
| Epitopic |
| GTPL7474 |
| HMS2231D18 |
| HY-17569 |
| MFCD00214273 |
| MLS000028663 |
| MLS001148580 |
| MLS001333701 |
| Myser |
| NCGC00168749-01 |
| Opera_ID_1287 |
| Pregna-1,4-diene-3,20-dione, 21-(acetyloxy)-6,9-difluoro-11-hydroxy-17-(1-oxobutoxy)-, (6alpha,11beta)- |
| Pregna-1,4-diene-3,20-dione, 6-alpha,9-difluoro-11-beta,17,21-trihydroxy-, 21-acetate, 17-butyrate |
| Q-101389 |
| Q736113 |
| Q827 |
| s4095 |
| S8A06QG2QE |
| SC-18767 |
| SCHEMBL4580 |
| SMR000058924 |
| SR-01000000265 |
| SR-01000000265-4 |
| st60-1 |
| Tox21_112628 |
| UNII-S8A06QG2QE |
| W 6309 |
| W-6309 |
| WYQPLTPSGFELIB-JTQPXKBDSA-N |
| ZINC4212945 |
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 |
|---|---|---|
| Japan | 3410364 | Start Trial |
| Germany | 69807281 | Start Trial |
| Canada | 2237503 | Start Trial |
| European Patent Office | 0878197 | Start Trial |
| Japan | H1129483 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
