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.
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Commercial
Trade Name
FDA
EMA
Alrex, Eysuvis, Inveltys, Lotemax, Lotemax sm, Loteprednol etabonate (discontinued: Lotemax, Loteprednol etabonate)
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 |
|---|---|---|---|---|
| EYSUVIS | Alcon Research | N-210933 RX | 2020-10-26 | 1 products, RLD, RS |
| INVELTYS | Alcon Research | N-210565 RX | 2018-08-22 | 1 products, RLD, RS |
| ALREX | Bausch Health Companies | N-020803 RX | 1998-03-09 | 1 products, RLD, RS |
| LOTEMAX | Bausch Health Companies | N-020583 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
Brand Name | Status | Last Update |
|---|---|---|
| alrex | New Drug Application | 2022-03-31 |
| eysuvis | New Drug Application | 2024-03-26 |
| inveltys | New Drug Application | 2024-03-27 |
| lotemax | New Drug Application | 2024-10-24 |
| lotemax sm | New Drug Application | 2023-03-17 |
| loteprednol etabonate | ANDA | 2024-12-17 |
| zylet | New Drug Application | 2022-04-30 |
Indications
FDA
EMA
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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
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Clinical
Clinical Trials
66 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Inflammation | D007249 | MP_0001845 | — | 1 | — | 12 | 5 | 2 | 20 |
| Dry eye syndromes | D015352 | — | H04.12 | 1 | 3 | 4 | 5 | 2 | 15 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | — | 3 | 4 | 5 | 1 | 13 |
| Cataract | D002386 | HP_0000518 | H26.9 | 1 | — | 8 | 2 | 2 | 13 |
| Conjunctivitis | D003231 | HP_0000509 | H10 | — | 1 | 4 | 5 | — | 10 |
| Keratoconjunctivitis | D007637 | — | H16.2 | 1 | 2 | 3 | 3 | — | 9 |
| Allergic conjunctivitis | D003233 | EFO_0007141 | H10.44 | 1 | 1 | 1 | 5 | — | 8 |
| Eye diseases | D005128 | EFO_0003966 | H44 | — | 2 | 2 | 3 | — | 7 |
| Blepharitis | D001762 | EFO_0009536 | H01.0 | — | 1 | 2 | 1 | — | 4 |
| Corneal edema | D015715 | EFO_1000879 | H18.20 | — | — | — | 3 | — | 3 |
Show 17 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 |
| Keratitis | D007634 | HP_0000491 | H16 | — | — | 2 | — | — | 2 |
| Uveitis | D014605 | HP_0000554 | H20.9 | — | — | 1 | — | 1 | 2 |
| Infections | D007239 | EFO_0000544 | — | — | — | 1 | — | — | 1 |
| Communicable diseases | D003141 | — | — | — | — | 1 | — | — | 1 |
| Bacterial conjunctivitis | D003234 | EFO_1000829 | H10.0 | — | — | 1 | — | — | 1 |
| Eye infections | D015817 | EFO_1001888 | — | — | — | 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 |
| Pharmacokinetics | D010599 | — | — | 1 | — | — | — | — | 1 |
Indications Without Phase
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Graft vs host disease | D006086 | — | D89.81 | — | — | — | — | 1 | 1 |
| 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 |
| Edema | D004487 | HP_0000969 | R60.9 | — | — | — | — | 1 | 1 |
| Macular degeneration | D008268 | EFO_0001365 | H35.30 | — | — | — | — | 1 | 1 |
Epidemiology
Epidemiological information for investigational and approved indications
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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 | — |
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Safety
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2,318 adverse events reported
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