ketorolac 0.5% — Competitive Intelligence Brief

ketorolac 0.5% (ketorolac 0.5%) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nonsteroidal anti-inflammatory drug (NSAID). Area: Ophthalmology.

marketed Nonsteroidal anti-inflammatory drug (NSAID) Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2) Ophthalmology Small molecule

Target snapshot

ketorolac 0.5% (ketorolac 0.5%) — Queen's University. Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and thereby decrease inflammation and pain.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
ketorolac 0.5% TARGET	ketorolac 0.5%	Queen's University	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2)
Pranoprofen eye drops	Pranoprofen eye drops	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1, COX-2)
Ketorolac Ophthalmic Solution	Ketorolac Ophthalmic Solution	Bausch & Lomb Incorporated	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1 and COX-2)
ASA	ASA	Biogen	marketed	Nonsteroidal anti-inflammatory drug (NSAID); antiplatelet agent	Cyclooxygenase-1 (COX-1); Cyclooxygenase-2 (COX-2)
aspirin + celecoxib	aspirin + celecoxib	Seoul National University Hospital	marketed	Nonsteroidal anti-inflammatory drug (NSAID) combination	COX-1 and COX-2 enzymes
Nerkardou (5 mg) & (10 mg)	Nerkardou (5 mg) & (10 mg)	Genuine Research Center, Egypt	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-2
optimized ibuprofen	optimized ibuprofen	OSF Healthcare System	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1, COX-2

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 (Nonsteroidal anti-inflammatory drug (NSAID) class)

1. Università degli Studi di Brescia · 4 drugs in this class
2. Bausch & Lomb Incorporated · 4 drugs in this class
3. Bayer · 3 drugs in this class
4. Pfizer · 3 drugs in this class
5. Azienda USL Reggio Emilia - IRCCS · 3 drugs in this class
6. Organon and Co · 3 drugs in this class
7. Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division · 2 drugs in this class
8. Bezmialem Vakif University · 2 drugs in this class
9. Guang'anmen Hospital of China Academy of Chinese Medical Sciences · 2 drugs in this class
10. Center For Excellence In Eye Care · 2 drugs in this class