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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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Commercial
Clinical
Drug
Target
Variants
Financial
Trends
Safety
Events Timeline
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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
Start date
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 Application2024-12-24
rifabutinNDA authorized generic2025-05-22
taliciaNew Drug Application2024-05-01
Indications
FDA
EMA
Indication
Ontology
MeSH
ICD-10
pulmonary tuberculosisEFO_1000049D014397A15
mycobacterium avium-intracellulare infectionEFO_0007386D015270—
mycobacterium infections—D009164A31.9
urinary tract infectionsEFO_0003103D014552N39.0
sinusitisEFO_0007486D012852J32
otitis mediaEFO_0004992D010033H66.9
gastroesophageal refluxEFO_0003948D005764K21
bacterial infections—D001424A49
bacterial skin diseases—D017192—
soft tissue infections—D018461—
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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
88 clinical trials
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Indications Phases 4
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
Mycobacterium avium-intracellulare infectionD015270EFO_0007386—1—2216
Mycobacterium avium complexD015269——1——2—3
Lung diseasesD008171EFO_0003818J98.4———2—2
Indications Phases 3
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
InfectionsD007239EFO_0000544—1—2—14
Mycobacterium infectionsD009164—A31.9——2—24
Hiv infectionsD015658EFO_0000764B201—1—13
Communicable diseasesD003141——1—1——2
Nontuberculous mycobacterium infectionsD009165EFO_0007461A31.9——1—12
MycosesD009181—B35-B49——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
Healthy volunteers/patients———1————1
Indications Without Phase
Indication
MeSH
Ontology
ICD-10
Ph 1
Ph 2
Ph 3
Ph 4
Other
Total
TuberculosisD014376EFO_0000774A15-A19————22
Acquired immunodeficiency syndromeD000163EFO_0000765B20————11
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
$
€
£
â‚£
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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 7,577 documents
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Safety
Black-box Warning
No Black-box warning
Adverse Events
Top Adverse Reactions
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2,382 adverse events reported
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