Tobrex, Tobi podhaler(tobramycin)
Bethkis, Kitabis, Tobi, Tobradex, Tobramycin, Tobrasone, Tobrex, Vantobra, Zylet (tobramycin) is a small molecule pharmaceutical. Tobramycin was first approved as Tobrex on 1982-01-01. It is used to treat bacterial eye infections, bacterial infections, central nervous system infections, infectious bone diseases, and infectious skin diseases amongst others in the USA. It has been approved in Europe to treat cystic fibrosis and respiratory tract infections.
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Commercial
Therapeutic Areas
Trade Name
FDA
EMA
Bethkis, Kitabis, Tobi, Tobramycin, Tobrex (discontinued: Aktob, Nebcin, Tobramycin, Tobrex)
CombinationsTobradex, Tobramycin dexamethasone, Zylet (discontinued: Tobramycin dexamethasone, Tobrasone)
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Tobramycin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| BETHKIS | Chiesi Farmaceutici | N-201820 RX | 2012-10-12 | 1 products, RLD, RS |
| TOBREX | Novartis | N-050555 RX | 1982-01-01 | 1 products, RLD, RS |
| KITABIS PAK | PulmoFlow | N-205433 RX | 2014-12-02 | 1 products |
| TOBI | Viatris | N-050753 RX | 1997-12-22 | 1 products, RLD, RS |
| TOBI PODHALER | Viatris | N-201688 RX | 2013-03-22 | 1 products, RLD, RS |
Show 1 discontinued
Dexamethasone
+
Tobramycin
Loteprednol etabonate
+
Tobramycin
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| ZYLET | Bausch Health Companies | N-050804 RX | 2004-12-14 | 1 products, RLD, RS |
Tobramycin sulfate
Tradename | Company | Number | Date | Products |
|---|---|---|---|---|
| TOBRAMYCIN SULFATE | Fresenius Kabi | N-050789 RX | 2004-07-13 | 1 products |
Show 2 discontinued
Labels
FDA
EMA
Brand Name | Status | Last Update |
|---|---|---|
| bethkis | New Drug Application | 2023-02-24 |
| kitabis pak | New Drug Application | 2024-11-22 |
| tobi | New Drug Application | 2023-02-15 |
| tobi podhaler | New Drug Application | 2023-02-15 |
| tobradex | New Drug Application | 2025-09-26 |
| tobradex st | New Drug Application | 2025-04-01 |
| tobramycin | ANDA | 2025-09-30 |
| tobramycin and dexamethasone | ANDA | 2025-10-03 |
| tobramycin inhalation | NDA authorized generic | 2023-02-24 |
| tobramycin inhalation solution | ANDA | 2024-12-17 |
Show 3 more
Indications
FDA
EMA
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Agency Specific
FDA
EMA
No data
Patent Expiration
Patent | Expires | Flag | FDA Information |
|---|---|---|---|
| Tobramycin, Tobi Podhaler, Mylan Speciality Lp | |||
| 10207066 | 2030-11-04 | DP | U-909 |
| 8869794 | 2028-09-12 | DP | U-909 |
| 7559325 | 2025-10-27 | DP | |
| 8664187 | 2025-06-20 | U-909 | |
| 11484671 | 2024-11-07 | DP | U-909 |
| RE47526 | 2024-04-09 | DP | |
| 7516741 | 2024-01-11 | DP | |
| Dexamethasone / Tobramycin, Tobradex St, Harrow Eye | |||
| 7795316 | 2028-08-03 | DP | U-1082 |
| 8101582 | 2027-12-19 | DP | U-1082 |
| 8450287 | 2027-12-19 | DP | |
ATC Codes
J: Antiinfectives for systemic use
— J01: Antibacterials for systemic use
— J01G: Aminoglycoside antibacterials
— J01GB: Other aminoglycosides in atc
— J01GB01: Tobramycin
S: Sensory organ drugs
— S01: Ophthalmologicals
— S01A: Antiinfective ophthalmologics
— S01AA: Antibiotics, ophthalmologic
— S01AA12: Tobramycin
HCPCS
Code | Description |
|---|---|
| J3260 | Injection, tobramycin sulfate, up to 80 mg |
| J7682 | Tobramycin, inhalation solution, fda-approved final product, non-compounded, unit dose form, administered through dme, per 300 milligrams |
| J7685 | Tobramycin, inhalation solution, compounded product, administered through dme, unit dose form, per 300 milligrams |
Clinical
Clinical Trials
185 clinical trials
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Indications Phases 4
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Blepharitis | D001762 | EFO_0009536 | H01.0 | — | — | 1 | 1 | — | 2 |
| Conjunctivitis | D003231 | — | H10 | — | — | 1 | 1 | — | 2 |
| Inflammation | D007249 | MP_0001845 | — | — | — | — | 1 | — | 1 |
| Keratoconjunctivitis | D007637 | — | H16.2 | — | — | — | 1 | — | 1 |
| Dry eye syndromes | D015352 | — | H04.12 | — | — | — | 1 | — | 1 |
| Meibomian gland dysfunction | D000080343 | — | H02.88 | — | — | — | 1 | — | 1 |
| Chalazion | D017043 | EFO_0007363 | H00.1 | — | — | — | 1 | — | 1 |
| Hordeolum | D006726 | EFO_0007315 | H00.01 | — | — | — | 1 | — | 1 |
Indications Phases 3
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
|---|---|---|---|---|---|---|---|---|---|
| Cataract | D002386 | EFO_0001059 | H26.9 | — | 1 | 1 | — | — | 2 |
| Keratitis | D007634 | — | H16 | — | — | 1 | — | — | 1 |
| Postoperative complications | D011183 | — | — | — | — | 1 | — | — | 1 |
| Eye infections | D015817 | EFO_1001888 | — | — | — | 1 | — | — | 1 |
Indications Phases 2
No data
Indications Phases 1
No data
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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Drug
General
| Drug common name | Tobramycin |
| INN | tobramycin |
| Description | Tobramycin is a amino cyclitol glycoside that is kanamycin B lacking the 3-hydroxy substituent from the 2,6-diaminoglucose ring. It has a role as an antibacterial agent, an antimicrobial agent and a toxin. It is functionally related to a kanamycin B. It is a conjugate base of a tobramycin(5+). |
| Classification | Small molecule |
| Drug class | antibiotics (Streptomyces strain) |
| Image (chem structure or protein) |  |
| Structure (InChI/SMILES or Protein Sequence) | NC[C@H]1O[C@H](O[C@@H]2[C@@H](N)C[C@@H](N)[C@H](O[C@H]3O[C@H](CO)[C@@H](O)[C@H](N)[C@H]3O)[C@H]2O)[C@H](N)C[C@@H]1O |
Identifiers
| PDB | — |
| CAS-ID | 32986-56-4 |
| RxCUI | — |
| ChEMBL ID | CHEMBL1747 |
| ChEBI ID | 28864 |
| PubChem CID | 36294 |
| DrugBank | DB00684 |
| UNII ID | VZ8RRZ51VK (ChemIDplus, GSRS) |
Target
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Variants
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Financial
Revenue by drug
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Estimated US medical usage
Tobramycin
+
Dexamethasone
Total medical expenditures per year (USD, in millions)
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Tobramycin
Total medical expenditures per year (USD, in millions)
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Trends
PubMed Central
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Safety
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No Black-box warning
Adverse Events
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17,556 adverse events reported
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