Topical IBU three times daily — Competitive Intelligence Brief

Topical IBU three times daily (Topical IBU three times daily) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: NSAID. Area: Pain management.

phase 3 NSAID COX-1 and COX-2 Pain management Small molecule

Target snapshot

Topical IBU three times daily (Topical IBU three times daily) — Pfizer. Topical IBU works by reducing pain and inflammation at the site of application.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Topical IBU three times daily TARGET	Topical IBU three times daily	Pfizer	phase 3	NSAID	COX-1 and COX-2
Cytotec	Misoprostol	Pfizer	marketed	NSAID combined with prostaglandin analog	Cyclooxygenase (COX-1 and COX-2); Prostaglandin receptors	1988-01-01
Ibuprofen Acid	Ibuprofen Acid	Reckitt Benckiser Healthcare (UK) Limited	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1 and 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)
Ketorolac Tromethamine 0.45%	Ketorolac Tromethamine 0.45%	Bucci Laser Vision Institute	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1 and COX-2)
Ropivacaine, Ketorolac and Adrenaline	Ropivacaine, Ketorolac and Adrenaline	University of Aarhus	marketed	Local anesthetic combination with NSAID and vasopressor	Voltage-gated sodium channels (ropivacaine); COX-1 and COX-2 (ketorolac); alpha and beta adrenergic receptors (adrenaline)
Surgery with Naproxen	Surgery with Naproxen	Giovana Maria Weckwerth	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 (NSAID class)

1. Antibe Therapeutics Inc. · 3 drugs in this class
2. Iroko Pharmaceuticals, LLC · 3 drugs in this class
3. Organon and Co · 2 drugs in this class
4. Apsen Farmaceutica S.A. · 2 drugs in this class
5. Amneal Pharmaceuticals, LLC · 2 drugs in this class
6. Behar, Caren, M.D. · 2 drugs in this class
7. IDEA AG · 2 drugs in this class
8. Noven Pharmaceuticals, Inc. · 2 drugs in this class
9. HALEON · 2 drugs in this class
10. Pfizer · 2 drugs in this class