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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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Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
5D
1M
3M
6M
YTD
1Y
2Y
5Y
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FDA approval date
EMA approval date
Patent expiration date
Study first post date
Last update post date
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Primary completion date
Completion date
Results first post 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 Application2024-07-22
rifabutinANDA2024-10-16
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
Clinical Trials
87 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Hiv infectionsD015658EFO_0000764B2011754935
InfectionsD007239EFO_000054455104731
TuberculosisD014376EFO_0000774A15-A1941124625
Mycobacterium avium-intracellulare infectionD015270EFO_00073861374620
Mycobacterium infectionsD009164A31.9481718
Communicable diseasesD0031413351517
Lung diseasesD008171HP_0002088J98.43326
BacteremiaD016470EFO_0003033R78.811146
Mycobacterium avium complexD01526911125
Pulmonary tuberculosisD014397EFO_1000049A1521114
Show 9 more
Indications Phases 2
Indications Phases 1
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Healthy volunteers/patients88
Bacterial infectionsD001424A4933
Opioid-related disordersD009293EFO_0005611F1111
OsteomyelitisD010019EFO_0003102M8611
Immunologic deficiency syndromesD007153HP_0002721D84.911
Renal insufficiencyD051437HP_0000083N1911
Indications Without Phase
No data
Epidemiology
Epidemiological information for investigational and approved indications
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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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Number of persons purchased
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Number of purchases
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Refill frequency
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Tabular view
Trends
PubMed Central
Top Terms for Disease or Syndrome:
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Additional graphs summarizing 7,197 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,026 adverse events reported
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