Loteprednol etabonate
Alrex, Eysuvis, Inveltys, Lotemax, Loteprednol Etabonate, 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
Events Timeline
Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
Max
Events
FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
Start date
Primary completion date
Completion date
Results first post date
Mock data
Subscribe for the real data
Subscribe for the real data
Commercial
Trade Name
FDA
EMA
Alrex, Eysuvis, Inveltys, Lotemax, Lotemax sm (generic drugs available since 2019-04-17)
CombinationsZylet
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 |
|---|---|---|---|---|
| INVELTYS | Alcon Research | N-210565 RX | 2018-08-22 | 1 products, RLD, RS |
| EYSUVIS | Alcon Research | N-210933 RX | 2020-10-26 | 1 products, RLD, RS |
| LOTEMAX | Bausch Health Companies | N-020583 RX | 1998-03-09 | 1 products, RLD, RS |
| ALREX | Bausch Health Companies | N-020803 RX | 1998-03-09 | 1 products, RLD, RS |
| LOTEMAX | Bausch Health Companies | N-200738 RX | 2011-04-15 | 1 products, RLD, RS |
| LOTEMAX | Bausch Health Companies | N-202872 RX | 2012-09-28 | 1 products, RLD, RS |
| LOTEMAX SM | Bausch Health Companies | N-208219 RX | 2019-02-22 | 1 products, RLD, RS |
Show 1 discontinued
Loteprednol etabonate
+
Tobramycin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZYLET | Bausch Health Companies | N-050804 RX | 2004-12-14 | 1 products, RLD, RS |
Labels
FDA
EMA
No data
Indications
FDA
EMA
Agency Specific
FDA
EMA
Expiration | Code | ||
|---|---|---|---|
LOTEPREDNOL ETABONATE, EYSUVIS, ALCON LABS INC | |||
| 2023-10-26 | NP | ||
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Loteprednol Etabonate, Lotemax Sm, Bausch And Lomb Inc | |||
| 10596107 | 2036-12-23 | DP | U-2764 |
| 11534395 | 2036-01-26 | DP | U-2764 |
| Loteprednol Etabonate, Eysuvis, Alcon Labs Inc | |||
| 9056057 | 2033-05-03 | DP | U-2491 |
| 9393213 | 2033-05-03 | DP | |
| 9532955 | 2033-05-03 | U-2491 | |
| 9737491 | 2033-05-03 | U-2492 | |
| 9827191 | 2033-05-03 | DP | U-2493, U-2985 |
| 10058511 | 2033-05-03 | DP | U-2492 |
| 10646436 | 2033-05-03 | DP | |
| 10688045 | 2033-05-03 | DP | |
| 10857096 | 2033-05-03 | U-2985 | |
| 10940108 | 2033-05-03 | U-2985 | |
| 10945948 | 2033-05-03 | U-2985 | |
| 10993908 | 2033-05-03 | U-3117 | |
| 11219596 | 2033-05-03 | U-2985 | |
| 11596599 | 2033-05-03 | U-2985 | |
| 11642317 | 2033-05-03 | DP | |
| Loteprednol Etabonate, Inveltys, Alcon Labs Inc | |||
| 10646437 | 2033-05-03 | DP | |
| 10864219 | 2033-05-03 | U-3011 | |
| 11219597 | 2033-05-03 | U-3278, U-3279 | |
ATC Codes
No data
HCPCS
No data
Clinical
Clinical Trials
68 clinical trials
View more details
Mock data
Subscribe for the real data
Subscribe for the real data
Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | MP_0001845 | — | 1 | — | 11 | 3 | 2 | 17 |
| Dry eye syndromes | D015352 | — | H04.12 | 1 | 2 | 3 | 5 | 2 | 13 |
| Allergic conjunctivitis | D003233 | EFO_0007141 | H10.44 | 1 | 1 | 1 | 4 | — | 7 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | — | 2 | 2 | 1 | — | 5 |
| Corneal edema | D015715 | EFO_1000879 | H18.20 | — | — | — | 3 | — | 3 |
| Conjunctivitis | D003231 | HP_0000509 | H10 | — | — | 1 | 2 | — | 3 |
| Intraocular pressure | D007429 | — | — | — | — | — | 2 | — | 2 |
| Ocular hypertension | D009798 | EFO_1001069 | H40.0 | — | — | — | 1 | 1 | 2 |
| Meibomian gland dysfunction | D000080343 | — | H02.88 | — | — | — | 1 | 1 | 2 |
| Pseudophakia | D019591 | — | — | — | — | — | 1 | 1 | 2 |
Show 8 more
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Pain | D010146 | EFO_0003843 | R52 | — | — | 5 | — | — | 5 |
| Cataract | D002386 | HP_0000518 | H26.9 | — | — | 4 | — | — | 4 |
| Blepharitis | D001762 | EFO_0009536 | H01.0 | — | 1 | 2 | — | — | 3 |
| Keratitis | D007634 | HP_0000491 | H16 | — | — | 2 | — | — | 2 |
| Bacterial conjunctivitis | D003234 | EFO_1000829 | H10.0 | — | — | 1 | — | — | 1 |
| Keratoconjunctivitis | D007637 | — | H16.2 | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Hypersensitivity | D006967 | HP_0012393 | T78.40 | 1 | — | — | — | — | 1 |
| Keratoconus | D007640 | EFO_0004223 | H18.6 | 1 | — | — | — | — | 1 |
| Healthy volunteers/patients | — | — | — | 1 | — | — | — | — | 1 |
| Eye pain | D058447 | HP_0200026 | H57.1 | 1 | — | — | — | — | 1 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Sjogren's syndrome | D012859 | EFO_0000699 | M35.0 | — | — | — | — | 1 | 1 |
| Macular edema | D008269 | — | — | — | — | — | — | 1 | 1 |
| Retinal vein occlusion | D012170 | EFO_1001157 | H34.81 | — | — | — | — | 1 | 1 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | — | — | — | 1 | 1 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | — | — | — | 1 | 1 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
View more details
Drug
General
| Drug common name | Loteprednol 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 class | prednisone 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-ID | 82034-46-6 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1200865 |
| ChEBI ID | 31784 |
| PubChem CID | 444025 |
| DrugBank | DB00873 |
| UNII ID | — |
Target
No data
Variants
No data
Financial
No data
Trends
PubMed Central
Top Terms for Disease or Syndrome:
Mock data
Subscribe for the real data
Subscribe for the real data
Additional graphs summarizing 1,226 documents
View more details
Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
Mock data
Subscribe for the real data
Subscribe for the real data
1,832 adverse events reported
View more details
© 2020-2024 Collaborative Drug Discovery Inc. (CDD) | Terms of Use