Skip to content
Loteprednol etabonate
Alrex, Eysuvis, Inveltys, Lotemax, Zylet (loteprednol etabonate) is a small molecule pharmaceutical. Loteprednol etabonate was first approved as Lotemax on 1998-03-09. It is used to treat allergic conjunctivitis, bacterial conjunctivitis, edema, inflammation, and iritis amongst others in the USA.
Download report
Favorite
Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
eye diseasesD005128
skin and connective tissue diseasesD017437
immune system diseasesD007154
signs and symptoms pathological conditionsD013568
Trade Name
FDA
EMA
Alrex, Eysuvis, Inveltys, Lotemax, Lotemax sm (generic drugs available since 2019-04-17)
Combinations
Zylet
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Loteprednol etabonate
Tradename
Company
Number
Date
Products
INVELTYSAlcon ResearchN-210565 RX2018-08-22
1 products, RLD, RS
EYSUVISAlcon ResearchN-210933 RX2020-10-26
1 products, RLD, RS
LOTEMAXBausch Health CompaniesN-020583 RX1998-03-09
1 products, RLD, RS
ALREXBausch Health CompaniesN-020803 RX1998-03-09
1 products, RLD, RS
LOTEMAXBausch Health CompaniesN-200738 RX2011-04-15
1 products, RLD, RS
LOTEMAXBausch Health CompaniesN-202872 RX2012-09-28
1 products, RLD, RS
LOTEMAX SMBausch Health CompaniesN-208219 RX2019-02-22
1 products, RLD, RS
Show 1 discontinued
Loteprednol etabonate
+
Tobramycin
Tradename
Company
Number
Date
Products
ZYLETBausch Health CompaniesN-050804 RX2004-12-14
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
alrexNew Drug Application2019-08-01
eysuvisNew Drug Application2020-11-18
inveltysNew Drug Application2020-04-30
lotemaxNew Drug Application2023-02-28
zyletNew Drug Application2021-10-29
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
allergic conjunctivitisEFO_0007141D003233H10.44
bacterial conjunctivitisEFO_1000829D003234H10.0
edema—D004487R60.9
inflammationMP_0001845D007249—
iritisEFO_1000997D007500—
keratitis—D007634H16
rosacea—D012393L71
viral conjunctivitisEFO_0008571D003236B30
Agency Specific
FDA
EMA
Expiration
Code
LOTEPREDNOL ETABONATE, EYSUVIS, ALCON LABS INC
2023-10-26NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Loteprednol Etabonate, Lotemax Sm, Bausch And Lomb Inc
105961072036-12-23DPU-2764
115343952036-01-26DPU-2764
Loteprednol Etabonate, Eysuvis, Alcon Labs Inc
90560572033-05-03DPU-2491
93932132033-05-03DP
95329552033-05-03U-2491
97374912033-05-03U-2492
98271912033-05-03DPU-2493, U-2985
100585112033-05-03DPU-2492
106464362033-05-03DP
106880452033-05-03DP
108570962033-05-03U-2985
109401082033-05-03U-2985
109459482033-05-03U-2985
109939082033-05-03U-3117
112195962033-05-03U-2985
115965992033-05-03U-2985
116423172033-05-03DP
Loteprednol Etabonate, Inveltys, Alcon Labs Inc
106464372033-05-03DP
108642192033-05-03U-3011
112195972033-05-03U-3278, U-3279
ATC Codes
No data
HCPCS
No data
Clinical
Indications Phases 4
No data
Indications Phases 3
No data
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
Drug common nameLOTEPREDNOL ETABONATE
INN—
Description
Loteprednol etabonate is an etabonate ester, an 11beta-hydroxy steroid, a steroid ester, an organochlorine compound, a steroid acid ester and a 3-oxo-Delta(1),Delta(4)-steroid. It has a role as an anti-inflammatory drug. It is functionally related to a loteprednol.
Classification
Small molecule
Drug classprednisone and prednisolone derivatives
Image (chem structure or protein)
Structure (InChI/SMILES or Protein Sequence)
CCOC(=O)O[C@]1(C(=O)OCCl)CC[C@H]2[C@@H]3CCC4=CC(=O)C=C[C@]4(C)[C@H]3[C@@H](O)C[C@@]21C
Identifiers
PDB—
CAS-ID82034-46-6
RxCUI52177
ChEMBL IDCHEMBL1200865
ChEBI ID31784
PubChem CID444025
DrugBankDB00873
UNII ID—
Target
Agency Approved
No data
Alternate
No data
Variants
Clinical Variant
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Additional graphs summarizing 747 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
66 adverse events reported
View more details