DrugPatentWatch Database Preview
DUREZOL Drug Profile
When do Durezol patents expire, and when can generic versions of Durezol launch?
Durezol is a drug marketed by Novartis Pharms Corp 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.
Summary for DUREZOL
| International Patents: | 6 |
| US Patents: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Suppliers / Packagers: | 1 |
| Bulk Api Vendors: | 43 |
| Clinical Trials: | 5 |
| Patent Applications: | 4,104 |
| 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 |
Generic Entry Opportunity Date for DUREZOL
Generic Entry Date for DUREZOL*:
Constraining patent/regulatory exclusivity:
PEDIATRIC EXCLUSIVITY NDA:
Dosage:
EMULSION;OPHTHALMIC |
*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.
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 |
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 Pharms Corp | DUREZOL | difluprednate | EMULSION;OPHTHALMIC | 022212-001 | Jun 23, 2008 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | Y | ➤ Try a Free Trial | |||
| Novartis Pharms Corp | DUREZOL | difluprednate | EMULSION;OPHTHALMIC | 022212-001 | Jun 23, 2008 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Novartis Pharms Corp | DUREZOL | difluprednate | EMULSION;OPHTHALMIC | 022212-001 | Jun 23, 2008 | RX | Yes | Yes | ➤ Try a Free Trial | ➤ Try a Free Trial | ➤ Try a Free Trial | ||||
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
Paragraph IV (Patent) Challenges for DUREZOL
| Drugname | Dosage | Strength | RLD | Date |
|---|---|---|---|---|
| ➤ Subscribe | Ophthalmic Emulsion | 0.05% | ➤ Subscribe | ➤ Try a Free Trial |
International Patents for DUREZOL
| Country | Patent Number | Estimated Expiration |
|---|---|---|
| Japan | H1129483 | ➤ Try a Free Trial |
| China | 1200926 | ➤ Try a Free Trial |
| Canada | 2237503 | ➤ Try a Free Trial |
| Country | Patent Number | Estimated Expiration |
