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Last Updated: December 9, 2019

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DIFLUPREDNATE - Generic Drug Details

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What are the generic sources for difluprednate and what is the scope of patent protection?

Difluprednate is the generic ingredient in one branded drug marketed by Novartis and is included in one NDA. There is one patent protecting this compound and one Paragraph IV challenge. Additional information is available in the individual branded drug profile pages.

Difluprednate has six patent family members in five countries.

There are four drug master file entries for difluprednate. One supplier is listed for this compound.

Recent Clinical Trials for DIFLUPREDNATE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Thomas M. LietmanPhase 4
Kaiser PermanentePhase 4
National Eye Institute (NEI)Phase 4

See all DIFLUPREDNATE clinical trials

Recent Litigation for DIFLUPREDNATE

Identify potential future generic entrants

PTAB Litigation
PetitionerDate
Akorn, Inc.2015-05-15

See all DIFLUPREDNATE litigation

Synonyms for DIFLUPREDNATE
(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 (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
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 DIFLUPREDNATE
Tradename Dosage Ingredient NDA Submissiondate
DUREZOL EMULSION;OPHTHALMIC difluprednate 022212 2014-05-01

US Patents and Regulatory Information for DIFLUPREDNATE

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
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 Y   Start Trial
>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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