systemic metronidazole and amoxicillin — Competitive Intelligence Brief

systemic metronidazole and amoxicillin (systemic metronidazole and amoxicillin) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antibiotic combination. Area: Infectious Disease / Periodontal Disease.

phase 3 Antibiotic combination Bacterial DNA (metronidazole); bacterial cell wall peptidoglycan (amoxicillin) Infectious Disease / Periodontal Disease Small molecule

Target snapshot

systemic metronidazole and amoxicillin (systemic metronidazole and amoxicillin) — The Forsyth Institute. A combination antibiotic therapy that kills anaerobic bacteria and gram-positive cocci through DNA damage and cell wall inhibition, respectively.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
systemic metronidazole and amoxicillin TARGET	systemic metronidazole and amoxicillin	The Forsyth Institute	phase 3	Antibiotic combination	Bacterial DNA (metronidazole); bacterial cell wall peptidoglycan (amoxicillin)
Duac® fixed dose combination gel	Duac® fixed dose combination gel	GlaxoSmithKline	marketed	Topical antibiotic combination	Bacterial ribosome (clindamycin); reactive oxygen species generation (benzoyl peroxide)
ceftriaxone/oxacillin	ceftriaxone/oxacillin	UPECLIN HC FM Botucatu Unesp	marketed	Beta-lactam antibiotic combination	Penicillin-binding proteins (PBPs)
Vonoprazan + amoxicillin	Vonoprazan + amoxicillin	The Third Xiangya Hospital of Central South University	marketed	Potassium-competitive acid blocker (PCAB) + beta-lactam antibiotic combination	H+/K+-ATPase (vonoprazan); bacterial cell wall peptidoglycan (amoxicillin)
Trimethoprim and sulfamethoxazole	Trimethoprim and sulfamethoxazole	National Institute of Allergy and Infectious Diseases (NIAID)	marketed	Sulfonamide antibiotic combination	Dihydropteroate synthase and dihydrofolate reductase
Vonoprazan-Amoxicillin Dual Therapy	Vonoprazan-Amoxicillin Dual Therapy	Nanjing First Hospital, Nanjing Medical University	marketed	Potassium-competitive acid blocker (PCAB) + beta-lactam antibiotic combination	H+/K+-ATPase (vonoprazan); bacterial cell wall peptidoglycan (amoxicillin)
metronidazole and doxycycline	metronidazole and doxycycline	Hospital de Clinicas de Porto Alegre	marketed	Antibiotic combination	Bacterial DNA (metronidazole); bacterial 30S ribosome (doxycycline)

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 (Antibiotic combination class)

1. Michael E. DeBakey VA Medical Center · 2 drugs in this class
2. University of South Florida · 2 drugs in this class
3. Halmstad County Hospital · 1 drug in this class
4. Hospital General Universitario Elche · 1 drug in this class
5. Hospital de Clinicas de Porto Alegre · 1 drug in this class
6. McMaster University · 1 drug in this class
7. Assistance Publique - Hôpitaux de Paris · 1 drug in this class
8. Shanghai Jiao Tong University School of Medicine · 1 drug in this class
9. The Cleveland Clinic · 1 drug in this class
10. The Forsyth Institute · 1 drug in this class