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AboutPricing
Drug ReportsRifabutin
Rifabutin
Mycobutin, Rifabutin, Talicia (rifabutin) is a small molecule pharmaceutical. Rifabutin was first approved as Mycobutin on 1992-12-23. It is used to treat mycobacterium avium-intracellulare infection, mycobacterium infections, and pulmonary tuberculosis in the USA.
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Drug
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Financial
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FDA approval date
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Commercial
Therapeutic Areas
Therapeutic Area
MeSH
infectionsD007239
respiratory tract diseasesD012140
Trade Name
FDA
EMA
Mycobutin, Rifabutin
Combinations
Talicia
Drug Products
FDA
EMA
New Drug Application (NDA)
New Drug Application (NDA)
Abbreviated New Drug Application (ANDA)
Abbreviated New Drug Application (ANDA)
Rifabutin
Tradename
Company
Number
Date
Products
MYCOBUTINPfizerN-050689 RX1992-12-23
1 products, RLD, RS
Amoxicillin
+
Omeprazole magnesium
+
Rifabutin
Tradename
Company
Number
Date
Products
TALICIARedHill BiopharmaN-213004 RX2019-11-01
1 products, RLD, RS
Labels
FDA
EMA
Brand Name
Status
Last Update
mycobutinNew Drug Application2024-12-24
rifabutinNDA authorized generic2025-01-13
taliciaNew Drug Application2024-05-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
pulmonary tuberculosisEFO_1000049D014397A15
mycobacterium avium-intracellulare infectionEFO_0007386D015270
mycobacterium infectionsD009164A31.9
urinary tract infectionsEFO_0003103D014552N39.0
sinusitisEFO_0007486D012852J32
otitis mediaEFO_0004992D010033H66.9
gastroesophageal refluxEFO_0003948D005764K21
bacterial infectionsD001424A49
bacterial skin diseasesD017192
soft tissue infectionsD018461
Show 12 more
Agency Specific
FDA
EMA
Expiration
Code
AMOXICILLIN / OMEPRAZOLE MAGNESIUM / RIFABUTIN, TALICIA, REDHILL
2027-11-01GAIN
2022-11-01NP
Patent Expiration
Patent
Expires
Flag
FDA Information
Amoxicillin / Omeprazole Magnesium / Rifabutin, Talicia, Redhill
118780112042-05-27U-3816
90502632034-02-12DPU-2660
94984452034-02-12DPU-2660
96038062034-02-12DPU-2660
102386062034-02-12DP
111351722034-02-12DPU-2660
ATC Codes
A: Alimentary tract and metabolism drugs
A02: Drugs for acid related disorders
A02B: Drugs for peptic ulcer and gastro-oesophageal reflux disease (gord)
A02BD: Combinations for eradication of helicobacter pylori
A02BD16: Omeprazole, amoxicillin and rifabutin
J: Antiinfectives for systemic use
J04: Antimycobacterials
J04A: Drugs for treatment of tuberculosis
J04AB: Antibiotics, antitubercular
J04AB04: Rifabutin
HCPCS
No data
Clinical
No data
Drug
General
Drug common nameRifabutin
INNrifabutin
Description
Rifabutin (Rfb) is an antibiotic used to treat tuberculosis and prevent and treat Mycobacterium avium complex. It is typically only used in those who cannot tolerate rifampin such as people with HIV/AIDS on antiretrovirals. For active tuberculosis it is used with other antimycobacterial medications. For latent tuberculosis it may be used by itself when the exposure was with drug-resistant TB.
Classification
Small molecule
Drug classantibiotics (rifamycin derivatives)
Image (chem structure or protein)Loading
Structure (InChI/SMILES or Protein Sequence)
CO[C@H]1/C=C/O[C@@]2(C)Oc3c(C)c(O)c4c(c3C2=O)C2=NC3(CCN(CC(C)C)CC3)NC2=C(NC(=O)/C(C)=C\C=C\[C@H](C)[C@H](O)[C@@H](C)[C@@H](O)[C@@H](C)[C@H](OC(C)=O)[C@@H]1C)C4=O
Identifiers
PDB
CAS-ID72559-06-9
RxCUI
ChEMBL IDCHEMBL444633
ChEBI ID45367
PubChem CID6323490
DrugBankDB00615
UNII ID1W306TDA6S (ChemIDplus, GSRS)
Target
No data
Variants
No data
Financial
Revenue by drug
$
£
No data
Estimated US medical usage
Rifabutin
Total medical expenditures per year (USD, in millions)
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Trends
No data
Safety
Black-box Warning
No Black-box warning
Adverse Events
0 adverse events reported
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