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DUREZOL Drug Profile
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See Plans and PricingWhen do Durezol patents expire, and when can generic versions of Durezol launch?
Durezol is a drug marketed by Novartis and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.
This drug has six patent family members in five countries.
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.
US ANDA Litigation and Generic Entry Outlook for Durezol
Durezol was eligible for patent challenges on June 23, 2012.
Annual sales in 2017 were $119mm indicating the motivation for generic entry (peak sales were $164mm in 2016).
There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.
Indicators of Generic Entry
Summary for DUREZOL
| International Patents: | 6 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 40 |
| Clinical Trials: | 5 |
| Patent Applications: | 6,213 |
| 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 |
| DailyMed Link: | DUREZOL at DailyMed |
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 |
| (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 |
| AC1L9FFL |
| ACT03289 |
| AKOS027326853 |
| 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 |
| MolPort-003-941-118 |
| 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 |
| 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 | Y | Start Trial | |||
| Novartis | DUREZOL | difluprednate | EMULSION;OPHTHALMIC | 022212-001 | Jun 23, 2008 | RX | Yes | Yes | Start Trial | Start Trial | Start Trial | ||||
| 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 |
| European Patent Office | 0878197 | Start Trial |
| China | 1200926 | Start Trial |
| Canada | 2237503 | Start Trial |
| Germany | 69807281 | Start Trial |
| Japan | H1129483 | Start Trial |
| >Country | >Patent Number | >Estimated Expiration |
