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)
CombinationsLoteprednol etabonate tobramycin, 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 |
|---|---|---|---|---|
| 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 | 2025-03-11 |
| 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 | 2026-02-12 |
| loteprednol etabonate and tobramycin | NDA authorized generic | 2026-01-20 |
| 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
70 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 | 3 | 2 | 18 |
| Dry eye syndromes | D015352 | — | H04.12 | 1 | 3 | 4 | 6 | 2 | 16 |
| Cataract | D002386 | EFO_0001059 | H26.9 | 1 | — | 8 | 2 | 2 | 13 |
| Keratoconjunctivitis sicca | D007638 | EFO_1000906 | — | — | 3 | 4 | 2 | 1 | 10 |
| Conjunctivitis | D003231 | — | H10 | — | — | 4 | 4 | — | 8 |
| Keratoconjunctivitis | D007637 | — | H16.2 | — | 2 | 3 | 2 | — | 7 |
| Allergic conjunctivitis | D003233 | EFO_0007141 | H10.44 | 1 | 1 | 1 | 4 | — | 7 |
| Eye diseases | D005128 | EFO_0003966 | H44 | — | 2 | 2 | 1 | 1 | 6 |
| Blepharitis | D001762 | EFO_0009536 | H01.0 | — | 1 | 2 | 1 | — | 4 |
| Corneal edema | D015715 | EFO_1000879 | H18.20 | — | — | — | 3 | — | 3 |
Show 24 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 | — | H16 | — | — | 2 | — | — | 2 |
| Uveitis | D014605 | EFO_1001231 | 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 | EFO_0003785 | 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 |
| Edema | D004487 | — | R60.9 | — | — | — | — | 1 | 1 |
| Retinal diseases | D012164 | — | H35.9 | — | — | — | — | 1 | 1 |
| Frailty | D000073496 | — | R53.1 | — | — | — | — | 1 | 1 |
| Sarcopenia | D055948 | EFO_1000653 | M62.84 | — | — | — | — | 1 | 1 |
| Hip fractures | D006620 | EFO_0003964 | S72.00 | — | — | — | — | 1 | 1 |
| Bone fractures | D050723 | EFO_0003931 | T14.8 | — | — | — | — | 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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Adverse Events
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2,328 adverse events reported
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