Ketorolac Nasal Spray — Competitive Intelligence Brief

Ketorolac Nasal Spray (Ketorolac Nasal Spray) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nonsteroidal anti-inflammatory drug (NSAID). Area: Pain Management.

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

Target snapshot

Ketorolac Nasal Spray (Ketorolac Nasal Spray) — Hersh, Elliot V., DMD, MS, PhD. Ketorolac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis and provide analgesic and anti-inflammatory effects.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Ketorolac Nasal Spray TARGET	Ketorolac Nasal Spray	Hersh, Elliot V., DMD, MS, PhD	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1 and COX-2)
Topical NSAID	Topical NSAID	University of Nottingham	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1 and/or COX-2)
Aspirin 80	Aspirin 80	Shiraz University of Medical Sciences	marketed	Nonsteroidal anti-inflammatory drug (NSAID); antiplatelet agent	Cyclooxygenase-1 (COX-1); Cyclooxygenase-2 (COX-2)
Diclofenac Sodium Topical Gel, 1%	Diclofenac Sodium Topical Gel, 1%	Amneal Pharmaceuticals, LLC	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2)
Ibuprofen Tablets	Ibuprofen Tablets	Overseas Pharmaceuticals, Ltd.	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1 and COX-2
Diclofenac Potassium for Oral Solution	Diclofenac Potassium for Oral Solution	Depomed	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2)
Bromfenac eye drop	Bromfenac eye drop	Azienda USL Reggio Emilia - IRCCS	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (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