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Standard course macrolide — Competitive Intelligence Brief

Standard course macrolide (Standard course macrolide) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Macrolide antibiotic. Area: Infectious disease.

phase 3 Macrolide antibiotic 50S ribosomal subunit Infectious disease Small molecule Live · refreshed every 30 min

Target snapshot

Standard course macrolide (Standard course macrolide) — UMC Utrecht. Macrolides inhibit bacterial protein synthesis by binding to the 50S ribosomal subunit.

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Standard course macrolide TARGET Standard course macrolide UMC Utrecht phase 3 Macrolide antibiotic 50S ribosomal subunit
FMS azithromycin tablets FMS azithromycin tablets University of Taubate marketed Macrolide antibiotic Bacterial 50S ribosomal subunit
Azithromycin 1gm Azithromycin 1gm Ain Shams Maternity Hospital marketed Macrolide antibiotic Bacterial 50S ribosomal subunit
Clarithromycin (ST14) Clarithromycin (ST14) National Taiwan University Hospital marketed Macrolide antibiotic Bacterial 50S ribosomal subunit
CLDM 1% gel CLDM 1% gel GlaxoSmithKline marketed Lincosamide antibiotic Bacterial 50S ribosomal subunit
Linezolid antimicrobial-lock solution Linezolid antimicrobial-lock solution Clinica Universidad de Navarra, Universidad de Navarra marketed Oxazolidinone antibiotic Bacterial 50S ribosomal subunit
Azithromycin or placebo tablets Azithromycin or placebo tablets Rigshospitalet, Denmark marketed Macrolide antibiotic Bacterial 50S ribosomal subunit

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Macrolide antibiotic class)

  1. Pfizer · 6 drugs in this class
  2. Grünenthal GmbH · 4 drugs in this class
  3. Merck Sharp & Dohme LLC · 3 drugs in this class
  4. University of Taubate · 2 drugs in this class
  5. Lihir Medical Centre · 2 drugs in this class
  6. Thomas Jefferson University · 2 drugs in this class
  7. Copenhagen Studies on Asthma in Childhood · 1 drug in this class
  8. Ain Shams Maternity Hospital · 1 drug in this class
  9. Celltrion · 1 drug in this class
  10. London School of Hygiene and Tropical Medicine · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Standard course macrolide — Competitive Intelligence Brief. https://druglandscape.com/ci/standard-course-macrolide. Accessed 2026-05-13.

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