Oral norfloxacin — Competitive Intelligence Brief

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

marketed Fluoroquinolone antibiotic DNA gyrase, topoisomerase IV Infectious Disease Small molecule

Target snapshot

Oral norfloxacin (Oral norfloxacin) — Hospital Clinic of Barcelona. Norfloxacin is a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV, preventing DNA replication and transcription in susceptible bacteria.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Oral norfloxacin TARGET	Oral norfloxacin	Hospital Clinic of Barcelona	marketed	Fluoroquinolone antibiotic	DNA gyrase, topoisomerase IV
Ciprofloxacin 0.3%	Ciprofloxacin 0.3%	Indiana University School of Medicine	marketed	Fluoroquinolone antibiotic	DNA gyrase, topoisomerase IV
Ciprofloxacin Tablets & Metronidazole tablets	Ciprofloxacin Tablets & Metronidazole tablets	MinaPharm Pharmaceuticals	marketed	Fluoroquinolone + Nitroimidazole antibiotic combination	Bacterial DNA gyrase, topoisomerase IV (ciprofloxacin); anaerobic DNA (metronidazole)
group-B : Levofloxacin triple therapy	group-B : Levofloxacin triple therapy	Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh	marketed	Fluoroquinolone antibiotic combination therapy	Bacterial DNA gyrase, topoisomerase IV
levofloxacin; metronidazole	levofloxacin; metronidazole	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	marketed	Fluoroquinolone + Nitroimidazole combination antibiotic	Bacterial DNA gyrase, topoisomerase IV (levofloxacin); bacterial DNA (metronidazole)
Ofloxacin 0.3%	Ofloxacin 0.3%	Indiana University School of Medicine	marketed	Fluoroquinolone antibiotic	DNA gyrase, Topoisomerase IV
ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin	ciprofloxacin, cotrimoxazole-trimethoprim, macrodantin	University of British Columbia	marketed	Fluoroquinolone, Sulfonamide-diaminopyrimidine combination, Nitrofuran	Bacterial DNA gyrase, topoisomerase IV, dihydrofolate reductase, bacterial DNA

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 (Fluoroquinolone antibiotic class)

1. Bayer · 4 drugs in this class
2. Allergan · 4 drugs in this class
3. Mackay Memorial Hospital · 2 drugs in this class
4. Indiana University School of Medicine · 2 drugs in this class
5. Cubist Pharmaceuticals LLC, a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA) · 1 drug in this class
6. Daewon Pharmaceutical Co., Ltd. · 1 drug in this class
7. Connect Biopharma Australia Pty Ltd · 1 drug in this class
8. GlaxoSmithKline · 1 drug in this class
9. Global Alliance for TB Drug Development · 1 drug in this class
10. Fundacion Clinic per a la Recerca Biomédica · 1 drug in this class