Wednesday, July 8, 2026

Drug profile · INN

rifabutin

rifabutin (MYCOBUTIN) is a bacterial dna-directed rna polymerase inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

FDA: approved TGA: approved
US status approved
Patents linked 11
Pipeline programs 1
News articles 0
Drug details — rifabutin
US status
approved
Class
Route
ORAL
Patents
11
Programs
1
Data quality
0.84

Quick answer

rifabutin (MYCOBUTIN) is a bacterial dna-directed rna polymerase inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

Key facts

INN rifabutin
Brand MYCOBUTIN
Mechanism Bacterial DNA-directed RNA polymerase inhibitor
Target Bacterial DNA-directed RNA polymerase
Route ORAL
Formulation CAPSULE

Mechanism of action

Bacterial DNA-directed RNA polymerase inhibitor

Primary target: Bacterial DNA-directed RNA polymerase

Approval history

Authority Status Date
FDA approved
TGA approved

Pipeline programs

  1. RHB-104-04 Phase 3 · RedHill Biopharma · Crohn Disease

Related & competitor drugs

  1. rifampin Bacterial DNA-directed RNA polymerase inhibitor
  2. rifapentine Bacterial DNA-directed RNA polymerase inhibitor
  3. rifaximin Bacterial DNA-directed RNA polymerase inhibitor
  4. rifampicin Bacterial DNA-directed RNA polymerase inhibitor
  1. US 11931463

    All-in-one fixed-dose combination for treating Helicobacter pylori infection

    Expires Mon Mar 14 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  2. US 11878011

    Method for eradicating Helicobacter pylori infection in patients regardless of body mass index

    Expires Mon Jan 18 2044 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  3. US 11135172

    Rifabutin-based compositions and methods for treating Helicobacter pylori infection

    Expires Mon Sep 30 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  4. US 11090326

    Fixed-dose pharmaceutical composition comprising rifabutin, clarithromycin, and clofazimine

    Expires Mon Aug 12 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  5. US 10238606

    Pharmaceutical compositions for the treatment of Helicobacter pylori

    Expires Mon Mar 21 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  6. US 10143702

    Fixed-dose pharmaceutical composition comprising rifabutin, clarithromycin, and clofazimine

    Expires Mon Nov 29 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  7. US 9603806

    Pharmaceutical compositions for the treatment of Helicobacter pylori

    Expires Mon Mar 23 2037 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  8. US 9498445

    Pharmaceutical compositions for the treatment of Helicobacter pylori

    Expires Mon Nov 17 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  9. US 9314477

    Compositions comprising rifabutin, clarithromycin, and clofazimine and uses thereof

    Expires Mon Apr 14 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  10. US 9198926

    Methods and compositions comprising rifabutin, clarithromycin, and clofazimine

    Expires Mon Nov 26 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted
  11. US 9050263

    Pharmaceutical compositions for the treatment of Helicobacter pylori

    Expires Mon Jun 04 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is rifabutin?

rifabutin (MYCOBUTIN) is a bacterial dna-directed rna polymerase inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: oral. Current US regulatory status: approved.

What is the brand name for rifabutin?

MYCOBUTIN is a marketed brand name for rifabutin. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of rifabutin?

rifabutin has approved status in the United States according to our Drugs@FDA-derived records. Verify on the official FDA label before clinical or commercial decisions.