ketorolac tromethamine 0.4% — Competitive Intelligence Brief

ketorolac tromethamine 0.4% (ketorolac tromethamine 0.4%) 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 (COX-1 and COX-2) Ophthalmology Small molecule

Target snapshot

ketorolac tromethamine 0.4% (ketorolac tromethamine 0.4%) — Clinica Oftamologica Zona Sul. Ketorolac tromethamine is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
ketorolac tromethamine 0.4% TARGET	ketorolac tromethamine 0.4%	Clinica Oftamologica Zona Sul	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1 and COX-2)
ketorolac (Acular LS)	ketorolac (Acular LS)	Center For Excellence In Eye Care	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1 and COX-2)
aspirin (ASA)	aspirin (ASA)	Janssen Scientific Affairs, LLC	marketed	Nonsteroidal anti-inflammatory drug (NSAID); antiplatelet agent	Cyclooxygenase-1 (COX-1); Cyclooxygenase-2 (COX-2)
0,09% Bromfenac	0,09% Bromfenac	Hospital de La Luz	marketed	Nonsteroidal Anti-Inflammatory Drug (NSAID)	Cyclooxygenase-2 (COX-2)
Diclofenac oral + Placebo Oral	Diclofenac oral + Placebo Oral	Hospital de Clinicas de Porto Alegre	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1 and COX-2
Novel strategy Aspirin	Novel strategy Aspirin	Assistance Publique - Hôpitaux de Paris	marketed	Nonsteroidal anti-inflammatory drug (NSAID); antiplatelet agent	Cyclooxygenase-1 (COX-1); Cyclooxygenase-2 (COX-2)
ABS	ABS	Teva Branded Pharmaceutical Products R&D, Inc.	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1 and 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