Ketorolac Tromethamine 0.45% — Competitive Intelligence Brief

Ketorolac Tromethamine 0.45% (Ketorolac Tromethamine 0.45%) 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 0.45% (Ketorolac Tromethamine 0.45%) — Bucci Laser Vision Institute. Ketorolac tromethamine 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 Tromethamine 0.45% TARGET	Ketorolac Tromethamine 0.45%	Bucci Laser Vision Institute	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1 and COX-2)
Ibuprofen bolus injection	Ibuprofen bolus injection	Federal Research and Clinical Centre of Intensive Care Medicine and Rehabilitology	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2)
Ketorolac, intramuscular	Ketorolac, intramuscular	The University of Texas Medical Branch, Galveston	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2)
Bromfenac 0.09 % Ophthalmic Solution	Bromfenac 0.09 % Ophthalmic Solution	Azienda USL Reggio Emilia - IRCCS	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1 and COX-2)
Topical Diclofenac gel 1%	Topical Diclofenac gel 1%	University of California, Davis	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1 and COX-2
Aspirin monotherapy	Aspirin monotherapy	Harbin Medical University	marketed	Nonsteroidal anti-inflammatory drug (NSAID); antiplatelet agent	Cyclooxygenase-1 (COX-1); Cyclooxygenase-2 (COX-2)
Aspirin treatment	Aspirin treatment	VA Office of Research and Development	marketed	Nonsteroidal anti-inflammatory drug (NSAID); antiplatelet agent	Cyclooxygenase-1 (COX-1); Cyclooxygenase-2 (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