High Dose Ibuprofen — Competitive Intelligence Brief

High Dose Ibuprofen (High Dose Ibuprofen) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nonsteroidal anti-inflammatory drug (NSAID). Area: Pain Management, Inflammation, Rheumatology.

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

Target snapshot

High Dose Ibuprofen (High Dose Ibuprofen) — Ottawa Hospital Research Institute. High-dose ibuprofen inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation, pain, and fever.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
High Dose Ibuprofen TARGET	High Dose Ibuprofen	Ottawa Hospital Research Institute	marketed	Nonsteroidal anti-inflammatory drug (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
Metamizole and Ibuprofen	Metamizole and Ibuprofen	University Hospital, Basel, Switzerland	marketed	Nonsteroidal anti-inflammatory drug (NSAID) combination	Cyclooxygenase (COX-1 and COX-2)
Ketorolac Nasal Spray	Ketorolac Nasal Spray	Hersh, Elliot V., DMD, MS, PhD	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1 and COX-2)
Bromfenac Sodium 0.07%	Bromfenac Sodium 0.07%	Retina Research Institute, LLC	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1 and COX-2)
Topical diclofenac sodium gel	Topical diclofenac sodium gel	Guang'anmen Hospital of China Academy of Chinese Medical Sciences	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1 and COX-2 enzymes
Tylenol and Ibuprofen only	Tylenol and Ibuprofen only	The Cooper Health System	marketed	Analgesic/Antipyretic combination (acetaminophen + NSAID)	Prostaglandin synthesis pathway; COX-1 and COX-2 enzymes

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