Wednesday, July 8, 2026
🇺🇸 FDA

Drug profile · INN

azithromycin

APO-AZITHROMYCIN

azithromycin (APO-AZITHROMYCIN) is a bacterial 70s ribosome inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: ophthalmic. Current US regulatory status: approved.

FDA: approved TGA: approved NMPA: clinical trials
US status approved
Patents linked 20
Pipeline programs 21
News articles 1
Drug details — azithromycin
US status
approved
Class
—
Route
OPHTHALMIC
Patents
20
Programs
21
Data quality
0.89
← All drugs Manufacturer profile Related patents Pipeline programs Drug news hub Event calendar

Quick answer

azithromycin (APO-AZITHROMYCIN) is a bacterial 70s ribosome inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: ophthalmic. Current US regulatory status: approved.

Key facts

INN azithromycin
Brand APO-AZITHROMYCIN
Mechanism Bacterial 70S ribosome inhibitor
Target Bacterial 70S ribosome
Route OPHTHALMIC
Formulation TABLET
Originator Pfizer Australia Pty Ltd

Mechanism of action

Bacterial 70S ribosome inhibitor

Primary target: Bacterial 70S ribosome

Approval history

Authority Status Date
FDA approved —
TGA approved —
NMPA clinical trials —

Recent coverage

View all news
FDA Approves Zithromax for Pediatric Community-Acquired Pneumonia
High impact NewsInfectious DiseasesApr 7, 2026

FDA Approves Zithromax for Pediatric Community-Acquired Pneumonia

FDA · Infectious Diseases · 6 min

The FDA has officially approved Zithromax for the treatment of pediatric community-acquired pneumonia, providing a vital option for managing this common respiratory condition in children.

Dr. Sarah Mitchell

Pipeline programs

Search pipeline Sponsor programs
  1. APHP230841 Phase 3 · PARItec · Population of study participants Pregnant women with PPROM a
  2. APHP241013 Phase 3 · PARItec · Young Adults and adults with R/R B-cell acute lymphoblastic
  3. AUTOP 2 Phase 3 · Ishita Pharma - · Bacterial vaginosis, High risk preterm birth pregnancy, Vagi
  4. Azithromycin Phase 3 · Cardiff Oncology · Bronchopulmonary Dysplasia
  5. Azithromycin plus hydroxychloroquine Phase 3 · Iterum Therapeutics · Respiratory Tract Infection Viral
  6. INS-416 Phase 3 · Insmed Incorporated · "Adult Subjects with Newly Diagnosed Nontuberculous Mycobact
  7. NCT02735707 Phase 3 · Disc Medicine · Respiratory tract infection
  8. azithromycin SR (Zithromax; compound: CP-62,993) Phase 3 · Pfizer · Bronchitis, Chronic

Related & competitor drugs

Browse all drugs
  1. chloramphenicol Bacterial 70S ribosome inhibitor
  2. clarithromycin Bacterial 70S ribosome inhibitor
  3. clindamycin hydrochloride Bacterial 70S ribosome inhibitor
  4. clindamycin palmitate hydrochloride Bacterial 70S ribosome inhibitor
  5. clindamycin phosphate Bacterial 70S ribosome inhibitor
  6. demeclocycline hydrochloride Bacterial 70S ribosome inhibitor

Related patents

Browse patents Pfizer Australia Pty Ltd patent hub

  1. US 12383540

    Compounds that modulates AMPA receptor function

    Expires Mon Aug 07 2045 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  2. US 11298345

    Compounds that modulates AMPA receptor function

    Expires Mon Apr 07 2042 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  3. US 11186567

    AMPA receptor potentiators

    Expires Mon Nov 25 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  4. US 11083696

    Dispersion anaesthetic device

    Expires Mon Aug 05 2041 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  5. US 10564161

    Method for identifying a bacterial infection

    Expires Mon Feb 13 2040 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  6. US 10209255

    Method for identifying a bacterial infection

    Expires Mon Feb 14 2039 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  7. US 10005810

    Process for preparing nucleoside prodrugs

    Expires Mon Jun 21 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  8. US 9918986

    Methods and compounds for preventing osteoarthritis

    Expires Mon Mar 15 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  9. US 9896729

    Method for diagnosing a neurodegenerative disease

    Expires Mon Feb 15 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  10. US 9867795

    Nitrated lipids and methods of making and using thereof

    Expires Mon Jan 11 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  11. US 9861606

    Therapeutic for treating inflammatory lung disorders

    Expires Mon Jan 04 2038 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  12. US 9827394

    Dispersion anaesthetic device

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

    granted

  13. US 9522156

    Nitrated lipids and methods of making and using thereof

    Expires Mon Dec 15 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  14. US 9295678

    Nitrated lipids and methods of making and using thereof

    Expires Mon Mar 24 2036 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  15. US 9006473

    Nitrated lipids and methods of making and using thereof

    Expires Mon Apr 09 2035 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  16. US 8835380

    Therapeutic conjugates

    Expires Mon Sep 11 2034 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  17. US 8551966

    Chemical compounds

    Expires Mon Oct 03 2033 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  18. US 8309526

    Nitrated lipids and methods of making and using thereof

    Expires Mon Nov 08 2032 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  19. US 7481995

    Aerosol composition

    Expires Mon Jan 22 2029 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

  20. US 7052890

    Transglutaminase gene products

    Expires Mon May 25 2026 00:00:00 GMT+0000 (Coordinated Universal Time)

    granted

Frequently asked questions

What is azithromycin?

azithromycin (APO-AZITHROMYCIN) is a bacterial 70s ribosome inhibitor. Associated with Pfizer Australia Pty Ltd. Route of administration: ophthalmic. Current US regulatory status: approved.

What is the brand name for azithromycin?

APO-AZITHROMYCIN is a marketed brand name for azithromycin. Check FDA Drugs@FDA for the current US label holder and prescribing information.

What is the US approval status of azithromycin?

azithromycin 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.

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