Brand Name | Status | Last Update |
---|---|---|
amikacin sulfate | ANDA | 2024-06-14 |
amikacin sulfate injection, 500 mg/2ml | Export only | 2021-01-03 |
arikayce | New Drug Application | 2025-03-17 |
Expiration | Code | ||
---|---|---|---|
AMIKACIN SULFATE, ARIKAYCE KIT, INSMED INC | |||
2030-09-28 | GAIN | ||
2025-09-28 | ODE-214 |
Patent | Expires | Flag | FDA Information |
---|---|---|---|
Amikacin Sulfate, Arikayce Kit, Insmed Inc | |||
9895385 | 2035-05-15 | U-2417 | |
10251900 | 2035-05-15 | U-2414 | |
10751355 | 2035-05-15 | U-2414 | |
11446318 | 2035-05-15 | U-2414 | |
9566234 | 2034-01-18 | DP | U-2415 |
8226975 | 2028-08-15 | DP | |
8632804 | 2026-12-05 | U-2416 | |
8642075 | 2026-12-05 | DP | |
8679532 | 2026-12-05 | U-2415 | |
7718189 | 2025-06-06 | DP | U-2415 |
8802137 | 2024-04-08 | DP | U-2414 |
9827317 | 2024-04-08 | DP | U-2415 |
Code | Description |
---|---|
J0278 | Injection, amikacin sulfate, 100 mg |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Infections | D007239 | EFO_0000544 | — | 2 | 5 | 9 | 6 | 8 | 28 |
Pneumonia | D011014 | EFO_0003106 | J18 | — | 11 | 6 | 5 | 7 | 27 |
Communicable diseases | D003141 | — | — | 1 | 3 | 5 | 3 | 8 | 19 |
Sepsis | D018805 | EFO_0001420 | A41.9 | — | 1 | 3 | 3 | 7 | 13 |
Tuberculosis | D014376 | EFO_0000774 | A15-A19 | 1 | 2 | 2 | 3 | 4 | 12 |
Fibrosis | D005355 | — | — | 3 | 3 | 2 | 2 | 3 | 11 |
Ventilator-associated pneumonia | D053717 | EFO_1001865 | J95.851 | — | 4 | 3 | 3 | 3 | 11 |
Urinary tract infections | D014552 | EFO_0003103 | N39.0 | 1 | 1 | — | 2 | 5 | 9 |
Lung diseases | D008171 | EFO_0003818 | J98.4 | 1 | 4 | 2 | 1 | 1 | 8 |
Multidrug-resistant tuberculosis | D018088 | EFO_0007381 | — | — | 2 | 2 | 3 | 1 | 8 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Cystic fibrosis | D003550 | EFO_0000390 | E84 | 3 | 3 | 3 | — | 7 | 14 |
Mycobacterium infections | D009164 | — | A31.9 | — | 5 | 5 | — | — | 9 |
Nontuberculous mycobacterium infections | D009165 | EFO_0007461 | A31.9 | — | 3 | 4 | — | — | 7 |
Bacterial pneumonia | D018410 | EFO_1001272 | J15.9 | — | 6 | 1 | — | — | 7 |
Septic shock | D012772 | — | A48.3 | — | — | 1 | — | 3 | 4 |
Persistent infection | D000088562 | — | — | 2 | 2 | 1 | — | — | 4 |
Mycobacterium avium-intracellulare infection | D015270 | EFO_0007386 | — | — | 1 | 2 | — | — | 3 |
Neonatal sepsis | D000071074 | — | — | — | — | 1 | — | 2 | 3 |
Chronic obstructive pulmonary disease | D029424 | EFO_0000341 | J44.9 | 1 | — | 1 | — | 1 | 3 |
Ototoxicity | D000081015 | — | — | — | 3 | 1 | — | — | 3 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Hiv infections | D015658 | EFO_0000764 | B20 | — | 1 | — | — | 2 | 3 |
Respiratory aspiration | D053120 | EFO_1001839 | — | — | 2 | — | — | 1 | 3 |
Urinary bladder neoplasms | D001749 | — | C67 | — | 1 | — | — | — | 1 |
Urologic surgical procedures | D013520 | — | — | — | 1 | — | — | — | 1 |
Nontuberculous mycobacteria | D009170 | — | — | — | 1 | — | — | — | 1 |
Abdominal abscess | D018784 | EFO_1001753 | — | — | 1 | — | — | — | 1 |
Extracorporeal membrane oxygenation | D015199 | — | — | — | 1 | — | — | — | 1 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Healthy volunteers/patients | — | — | — | 4 | — | — | — | 2 | 6 |
Osteomyelitis | D010019 | EFO_0003102 | M86 | 1 | — | — | — | — | 1 |
Obstructive lung diseases | D008173 | — | — | 1 | — | — | — | — | 1 |
Respiratory distress syndrome | D012128 | EFO_1000637 | J80 | 1 | — | — | — | — | 1 |
Necrotizing enterocolitis | D020345 | EFO_0003928 | K55.3 | 1 | — | — | — | — | 1 |
Newborn respiratory distress syndrome | D012127 | — | P22 | 1 | — | — | — | — | 1 |
Enterocolitis | D004760 | EFO_1001481 | — | 1 | — | — | — | — | 1 |
Indication | MeSH | Ontology | ICD-10 | Ph 1 | Ph 2 | Ph 3 | Ph 4 | Other | Total |
---|---|---|---|---|---|---|---|---|---|
Pharmacokinetics | D010599 | — | — | — | — | — | — | 3 | 3 |
Appendicitis | D001064 | EFO_0007149 | K37 | — | — | — | — | 3 | 3 |
Hemorrhage | D006470 | MP_0001914 | R58 | — | — | — | — | 2 | 2 |
Enterococcus | D016983 | — | — | — | — | — | — | 2 | 2 |
Respiratory tract infections | D012141 | — | J06.9 | — | — | — | — | 2 | 2 |
Keratitis | D007634 | — | H16 | — | — | — | — | 2 | 2 |
Chronic bronchitis | D029481 | — | J42 | — | — | — | — | 1 | 1 |
Bronchitis | D001991 | — | J40 | — | — | — | — | 1 | 1 |
Disease susceptibility | D004198 | — | — | — | — | — | — | 1 | 1 |
Endophthalmitis | D009877 | — | — | — | — | — | — | 1 | 1 |
Drug common name | Amikacin |
INN | amikacin |
Description | Amikacin is an amino cyclitol glycoside that is kanamycin A acylated at the N-1 position by a 4-amino-2-hydroxybutyryl group. It has a role as an antimicrobial agent, an antibacterial drug and a nephrotoxin. It is an alpha-D-glucoside, an aminoglycoside, a carboxamide and an amino cyclitol glycoside. It is functionally related to a kanamycin A. It is a conjugate base of an amikacin(4+). |
Classification | Small molecule |
Drug class | antibiotics obtained from Streptomyces kanamyceticus (related to kanamycin) |
Image (chem structure or protein) | ![]() |
Structure (InChI/SMILES or Protein Sequence) | NCC[C@H](O)C(=O)N[C@@H]1C[C@H](N)[C@@H](O[C@H]2O[C@H](CN)[C@@H](O)[C@H](O)[C@H]2O)[C@H](O)[C@H]1O[C@H]1O[C@H](CO)[C@@H](O)[C@H](N)[C@H]1O |
PDB | — |
CAS-ID | 37517-28-5 |
RxCUI | — |
ChEMBL ID | CHEMBL177 |
ChEBI ID | 2637 |
PubChem CID | 37768 |
DrugBank | DB00479 |
UNII ID | 84319SGC3C (ChemIDplus, GSRS) |