Azithromycin Ophthalmic Solution, 1% — Competitive Intelligence Brief

Azithromycin Ophthalmic Solution, 1% (Azithromycin Ophthalmic Solution, 1%) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Macrolide antibiotic. Area: Ophthalmology / Infectious Disease.

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

Target snapshot

Azithromycin Ophthalmic Solution, 1% (Azithromycin Ophthalmic Solution, 1%) — Merck Sharp & Dohme LLC. Azithromycin is a macrolide antibiotic that inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, thereby killing or stopping the growth of susceptible bacteria.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Azithromycin Ophthalmic Solution, 1% TARGET	Azithromycin Ophthalmic Solution, 1%	Merck Sharp & Dohme LLC	marketed	Macrolide antibiotic	Bacterial 50S ribosomal subunit
Linezolid (L)	Linezolid (L)	Shenzhen Third People's Hospital	marketed	Oxazolidinone antibiotic	Bacterial 50S ribosomal subunit
Erythromycin, Azithromycin , Clarithromycin	Erythromycin, Azithromycin , Clarithromycin	Baqiyatallah Medical Sciences University	marketed	Macrolide antibiotic	Bacterial 50S ribosomal subunit
FMS azithromycin tablets	FMS azithromycin tablets	University of Taubate	marketed	Macrolide antibiotic	Bacterial 50S ribosomal subunit
AzaSite®	AzaSite®	Merck Sharp & Dohme LLC	marketed	Macrolide antibiotic	Bacterial 50S ribosomal subunit
Clarithromycin (ST14)	Clarithromycin (ST14)	National Taiwan University Hospital	marketed	Macrolide antibiotic	Bacterial 50S ribosomal subunit
Azithromycin Oral Product	Azithromycin Oral Product	Thomas Jefferson University	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