Clarithromycin Syrup (125 mg) — Competitive Intelligence Brief

Clarithromycin Syrup (125 mg) (Clarithromycin Syrup (125 mg)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Macrolide antibiotic. Area: Infectious Disease.

phase 3 Macrolide antibiotic Bacterial 50S ribosomal subunit Infectious Disease Small molecule

Target snapshot

Clarithromycin Syrup (125 mg) (Clarithromycin Syrup (125 mg)) — Grünenthal GmbH. Clarithromycin inhibits bacterial protein synthesis by binding to the 50S ribosomal subunit, preventing peptide bond formation and bacterial growth.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Clarithromycin Syrup (125 mg) TARGET	Clarithromycin Syrup (125 mg)	Grünenthal GmbH	phase 3	Macrolide antibiotic	Bacterial 50S ribosomal subunit
Azithromycin or placebo tablets	Azithromycin or placebo tablets	Rigshospitalet, Denmark	marketed	Macrolide 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)
Administration of Azithromycin on Day 1	Administration of Azithromycin on Day 1	London School of Hygiene and Tropical Medicine	marketed	Macrolide antibiotic	Bacterial 50S ribosomal subunit
Clindamycin Gel (clindamycin )	Clindamycin Gel (clindamycin )	Stiefel, a GSK Company	marketed	Lincosamide antibiotic	Bacterial 50S ribosomal subunit
mass treatment with oral azithromycin	mass treatment with oral azithromycin	University of California, San Francisco	marketed	Macrolide antibiotic	Bacterial 50S ribosomal subunit
P.O roxithromycin 150 mg*2/d for 7 days	P.O roxithromycin 150 mg*2/d for 7 days	Western Galilee Hospital-Nahariya	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