levofloxacin, azithromycin, amoxicillin/clavulanate — Competitive Intelligence Brief

levofloxacin, azithromycin, amoxicillin/clavulanate (levofloxacin, azithromycin, amoxicillin/clavulanate) competitive landscape: 4 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Antibiotics. Area: Infectious Diseases.

phase 3 Antibiotics DNA gyrase, 50S ribosomal subunit, penicillin-binding proteins Infectious Diseases Small molecule

Target snapshot

levofloxacin, azithromycin, amoxicillin/clavulanate (levofloxacin, azithromycin, amoxicillin/clavulanate) — Johnson & Johnson Pharmaceutical Research & Development, L.L.C.. Levofloxacin, azithromycin, and amoxicillin/clavulanate inhibit bacterial growth through different mechanisms, targeting DNA gyrase, protein synthesis, and cell wall synthesis, respectively.

Comparator set (4 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
levofloxacin, azithromycin, amoxicillin/clavulanate TARGET	levofloxacin, azithromycin, amoxicillin/clavulanate	Johnson & Johnson Pharmaceutical Research & Development, L.L.C.	phase 3	Antibiotics	DNA gyrase, 50S ribosomal subunit, penicillin-binding proteins
Augmentin, Ceftriaxone, Cefotaxime, netilmycin, tobramycin	Augmentin, Ceftriaxone, Cefotaxime, netilmycin, tobramycin	Centre Hospitalier Universitaire de Besancon	marketed	Beta-lactam antibiotics and aminoglycosides	Bacterial cell wall (penicillin-binding proteins) and bacterial ribosome (30S subunit)
Dexamethasone, tobramycin, netilimicin	Dexamethasone, tobramycin, netilimicin	Kasr El Aini Hospital	marketed	Corticosteroid + aminoglycoside antibiotics	Glucocorticoid receptor (dexamethasone); bacterial 30S ribosome (tobramycin, netilimicin)
N-acetylcysteine + PPI-amoxicillin-clarithromycin	N-acetylcysteine + PPI-amoxicillin-clarithromycin	National Taiwan University Hospital	marketed	Triple therapy combination (mucolytic + PPI + dual antibiotics)
Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin	Ceftriaxone; Azithromycin; Amoxicilline/clavulanate; Clarithromycin	Bayer	phase 3	Beta-lactam antibiotics and macrolide antibiotics	Bacterial cell wall (penicillin-binding proteins) and bacterial ribosome (50S 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 (Antibiotics class)

1. Johnson & Johnson Pharmaceutical Research & Development, L.L.C. · 1 drug in this class