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Last Updated: December 15, 2019

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Loteprednol etabonate - Generic Drug Details

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What are the generic drug sources for loteprednol etabonate and what is the scope of patent protection?

Loteprednol etabonate is the generic ingredient in six branded drugs marketed by Bausch And Lomb Inc, Bausch And Lomb, Kala Pharms Inc, Pharmos, and Hi Tech, and is included in nine NDAs. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Loteprednol etabonate has forty-six patent family members in twelve countries.

There are ten drug master file entries for loteprednol etabonate. Four suppliers are listed for this compound.

Drug Prices for loteprednol etabonate

See drug prices for loteprednol etabonate

Recent Clinical Trials for loteprednol etabonate

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

SponsorPhase
SandozPhase 1
Zhongshan Ophthalmic Center, Sun Yat-sen UniversityPhase 4
Valeant Pharmaceuticals International, Inc.Phase 3

See all loteprednol etabonate clinical trials

Recent Litigation for loteprednol etabonate

Identify potential future generic entrants

District Court Litigation
Case NameDate
Alcon Pharmaceuticals v. Teva Pharmaceuticals2009-12-02
ASTRAZENECA LP v.BREATH LIMITED2008-03-19
Aventis Pharmaceuticals Inc. v. Barr Laboratories Inc.2006-05-02

See all loteprednol etabonate litigation

Pharmacology for loteprednol etabonate
Medical Subject Heading (MeSH) Categories for loteprednol etabonate
Synonyms for loteprednol etabonate
(8S,9S,10R,11S,13S,14S,17R)-chloromethyl 17-(ethoxycarbonyloxy)-11-hydroxy-10,13-dimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthrene-17-carboxylate
034L466
17-ethoxycarbonyloxy-11-hydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthrene-17-carboxylic acid chloromethyl ester
82034-46-6
A840238
AB0014233
AB00698349_08
AB00698349-05
AB00698349-07
AB2000207
AC-3403
AC1L9FKJ
AJ-113709
AK128804
AKOS005145741
AKOS015969680
AKOS016842709
AKOS025402030
AKOS026749817
Alrex
Alrex;Lotemax
AN-5197
Androsta-1,4-diene-17-carboxylic acid, 17-((ethoxycarbonyl)oxy)-11-hydroxy-3-oxo-, chloromethyl ester, (11beta,17alpha)-
AS-33225
BC208448
BCP28645
BRD-K43659793-001-01-6
C24H31ClO7
CAS-82034-46-6
CCG-101041
CDDD 5604
CDDD-5604
CEHOAC
CHEBI:31784
CHEMBL1200865
chloromethyl (10R,11S,13S,17R)-17-ethoxycarbonyloxy-11-hydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthrene-17-carboxylate
chloromethyl (1S,2R,10S,11S,14R,15S,17S)-14-[(ethoxycarbonyl)oxy]-17-hydroxy-2,15-dimethyl-5-oxotetracyclo[8.7.0.0^{2,7}.0^{11,15}]heptadeca-3,6-diene-14-carboxylate
chloromethyl (8S,9S,10R,11S,13S,14S,17R)-17-((ethoxycarbonyl)oxy)-11-hydroxy-10,13-dimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthrene-17-carb
chloromethyl (8S,9S,10R,11S,13S,14S,17R)-17-ethoxycarbonyloxy-11-hydroxy-10,13-dimethyl-3-oxo-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthrene-17-carboxylate
chloromethyl (8S,9S,10R,11S,13S,14S,17S)-17-((ethoxycarbonyl)oxy)-11-hydroxy-10,13-dimethyl-3-oxo-6,7,8,9,10,11,12,13,14,15,16,17-dodecahydro-3H-cyclopenta[a]phenanthrene-17-carboxylate
chloromethyl (8xi,9xi,11beta,14xi,17alpha)-17-[(ethoxycarbonyl)oxy]-11-hydroxy-3-oxoandrosta-1,4-diene-17-carboxylate
Chloromethyl 11beta,17-dihydroxy-3-oxoandrosta-1,4-diene-17beta-carboxylate, 17-(ethyl carbonate)
chloromethyl 17-ethoxycarbonyloxy-10,13-dimethyl-11-oxidanyl-3-oxidanylidene-7,8,9,11,12,14,15,16-octahydro-6H-cyclopenta[a]phenanthrene-17-carboxylate
chloromethyl 17-ethoxycarbonyloxy-11-hydroxy-3-oxoandrosta-1,4-diene-17-carboxylate
chloromethyl 17alpha-[(ethoxycarbonyl)oxy]-11beta-hydroxy-3-oxoandrosta-1,4-diene-17beta-carboxylate
CPD000469178
CS-0900
CTK8G0640
D01689
DMKSVUSAATWOCU-HROMYWEYSA-N
DSSTox_CID_26468
DSSTox_GSID_46468
DSSTox_RID_81641
DTXSID2046468
GS-3599
GTPL7085
HGP 1
HGP-1
HMS2051F16
HMS2232J09
HMS3655K17
HMS3715N06
HY-17358
I06-0442
IDR-90102
IDR-90103
Inveltys
K462
KS-00000GI4
Locort
Loteflam
Lotemax
Lotemax (TN)
Loteprednol etabonate (JAN/USAN)
Loteprednol etabonate [USAN:JAN]
Loteprednol etabonate [USAN]
Loteprednol etabonate Opphthalmic suspension
Loteprednol Etabonate, >=98% (HPLC)
Loterox
LS-177664
M-9411
MCULE-5760267673
MLS001424221
MolPort-003-848-424
MolPort-005-980-183
MolPort-006-830-025
MolPort-027-948-426
NC00291
NCGC00164594-01
NCGC00164594-02
P 5604
P-5604
s1669
SAM001246630
SCHEMBL12045348
SCHEMBL12738239
SCHEMBL13379816
SCHEMBL23907
SCHEMBL506024
SMR000469178
ST24030829
STL535468
SW219981-1
Tox21_112219
Tox21_112219_1
UNII-YEH1EZ96K6
YEH1EZ96K6
ZINC3920673
ZINC59803238

US Patents and Regulatory Information for loteprednol etabonate

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Pharmos LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020841-001 Mar 9, 1998 DISCN No No   Start Trial   Start Trial   Start Trial
Bausch And Lomb ZYLET loteprednol etabonate; tobramycin SUSPENSION/DROPS;OPHTHALMIC 050804-001 Dec 14, 2004 RX Yes Yes   Start Trial   Start Trial   Start Trial
Kala Pharms Inc INVELTYS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210565-001 Aug 22, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Kala Pharms Inc INVELTYS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210565-001 Aug 22, 2018 RX Yes Yes   Start Trial   Start Trial   Start Trial
Bausch And Lomb Inc LOTEMAX loteprednol etabonate GEL;OPHTHALMIC 202872-001 Sep 28, 2012 RX Yes Yes   Start Trial   Start Trial   Start Trial
Kala Pharms Inc INVELTYS loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 210565-001 Aug 22, 2018 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

Expired US Patents for loteprednol etabonate

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch And Lomb LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020583-001 Mar 9, 1998   Start Trial   Start Trial
Bausch And Lomb Inc LOTEMAX loteprednol etabonate GEL;OPHTHALMIC 202872-001 Sep 28, 2012   Start Trial   Start Trial
Pharmos LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020841-001 Mar 9, 1998   Start Trial   Start Trial
Pharmos LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020841-001 Mar 9, 1998   Start Trial   Start Trial
Bausch And Lomb LOTEMAX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020583-001 Mar 9, 1998   Start Trial   Start Trial
Bausch And Lomb ALREX loteprednol etabonate SUSPENSION/DROPS;OPHTHALMIC 020803-001 Mar 9, 1998   Start Trial   Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

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Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verifification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.