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Generated: November 16, 2018

DrugPatentWatch Database Preview

DUREZOL Drug Profile

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Which patents cover Durezol, 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.

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.

Drug patent expirations by year for DUREZOL
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
D01ZOG
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
hydroxyfluoroprednisolone butyrate
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 ➤ Sign Up ➤ Sign Up Y ➤ Sign Up
Novartis Pharms Corp DUREZOL difluprednate EMULSION;OPHTHALMIC 022212-001 Jun 23, 2008 RX Yes Yes ➤ Sign Up ➤ Sign Up ➤ Sign Up
Novartis Pharms Corp DUREZOL difluprednate EMULSION;OPHTHALMIC 022212-001 Jun 23, 2008 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

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Paragraph IV (Patent) Challenges for DUREZOL
Drugname Dosage Strength RLD Date
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Serving hundreds of leading biopharmaceutical companies globally:

Teva
Fish and Richardson
Deloitte
Federal Trade Commission
UBS
US Department of Justice
Colorcon
Fuji
Covington

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