OTO-201 (ciprofloxacin) — Competitive Intelligence Brief

OTO-201 (ciprofloxacin) (OTO-201 (ciprofloxacin)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Fluoroquinolone antibiotic. Area: Otology / Infectious Disease.

phase 3 Fluoroquinolone antibiotic Bacterial DNA gyrase and topoisomerase IV Otology / Infectious Disease Small molecule

Target snapshot

OTO-201 (ciprofloxacin) (OTO-201 (ciprofloxacin)) — Otonomy, Inc.. OTO-201 is a sustained-release formulation of ciprofloxacin, a fluoroquinolone antibiotic that inhibits bacterial DNA gyrase and topoisomerase IV to kill bacteria in the middle ear.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
OTO-201 (ciprofloxacin) TARGET	OTO-201 (ciprofloxacin)	Otonomy, Inc.	phase 3	Fluoroquinolone antibiotic	Bacterial DNA gyrase and topoisomerase IV
moxifloxacin 0.5% HCI ophthalmic solution	moxifloxacin 0.5% HCI ophthalmic solution	Allergan	marketed	Fluoroquinolone antibiotic	Bacterial DNA gyrase and topoisomerase IV
Moxifloxacin HCl 0.5%	Moxifloxacin HCl 0.5%	Carolina Eyecare Physicians, LLC	marketed	Fluoroquinolone antibiotic	Bacterial DNA gyrase and topoisomerase IV
Moxifloxacin 0.5% ophthalmic solution	Moxifloxacin 0.5% ophthalmic solution	Johns Hopkins University	marketed	Fluoroquinolone antibiotic	Bacterial DNA gyrase and topoisomerase IV
Moxifloxacin (Topical)	Moxifloxacin (Topical)	University of California, San Francisco	marketed	Fluoroquinolone antibiotic	Bacterial DNA gyrase and topoisomerase IV
Intracameral Moxifloxacin 0.1%	Intracameral Moxifloxacin 0.1%	Suzan A Rattan	marketed	Fluoroquinolone antibiotic	Bacterial DNA gyrase and topoisomerase IV
moxifloxacin 0.5% eye drops	moxifloxacin 0.5% eye drops	Allergan	marketed	Fluoroquinolone antibiotic	Bacterial DNA gyrase and topoisomerase IV

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