Azithromycin Oral Product — Competitive Intelligence Brief

Azithromycin Oral Product (Azithromycin Oral Product) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Macrolide antibiotic. Area: Infectious Disease.

marketed Macrolide antibiotic Bacterial 50S ribosomal subunit Infectious Disease Small molecule

Target snapshot

Azithromycin Oral Product (Azithromycin Oral Product) — Thomas Jefferson University. Azithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thereby stopping bacterial growth.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Azithromycin Oral Product TARGET	Azithromycin Oral Product	Thomas Jefferson University	marketed	Macrolide antibiotic	Bacterial 50S ribosomal subunit
Oral Suspension Tedizolid Phosphate	Oral Suspension Tedizolid Phosphate	Merck Sharp & Dohme LLC	marketed	Oxazolidinone antibiotic	Bacterial 50S ribosomal subunit
QS azithromycin tablets	QS azithromycin tablets	University of Taubate	marketed	Macrolide antibiotic	Bacterial 50S ribosomal subunit
Linezolid (L)	Linezolid (L)	Shenzhen Third People's Hospital	marketed	Oxazolidinone antibiotic	Bacterial 50S ribosomal subunit
clarithromycin, rifabutin	clarithromycin, rifabutin	The University of Texas Health Science Center at Tyler	marketed	Macrolide antibiotic and rifamycin antibiotic combination	Bacterial 50S ribosomal subunit (clarithromycin); bacterial RNA polymerase (rifabutin)
PRISTINAMYCIN XRP7263	PRISTINAMYCIN XRP7263	Sanofi	marketed	Macrolide antibiotic / Streptogramin	Bacterial 50S ribosomal subunit
Topical Clindamycin	Topical Clindamycin	University of Toronto	marketed	Lincosamide 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