Naproxen Sodium (Aleve) — Competitive Intelligence Brief

Naproxen Sodium (Aleve) (Naproxen Sodium (Aleve)) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nonsteroidal anti-inflammatory drug (NSAID). Area: Pain Management, Rheumatology, Cardiovascular.

phase 3 Nonsteroidal anti-inflammatory drug (NSAID) COX-1, COX-2 Pain Management, Rheumatology, Cardiovascular Small molecule

Target snapshot

Naproxen Sodium (Aleve) (Naproxen Sodium (Aleve)) — Seattle Institute for Biomedical and Clinical Research. Naproxen sodium inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin production, thereby decreasing inflammation, pain, and fever.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Naproxen Sodium (Aleve) TARGET	Naproxen Sodium (Aleve)	Seattle Institute for Biomedical and Clinical Research	phase 3	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1, COX-2
Experimental: Aspirin monotherapy	Experimental: Aspirin monotherapy	Chinese Academy of Medical Sciences, Fuwai Hospital	marketed	Nonsteroidal anti-inflammatory drug (NSAID) / Antiplatelet agent	COX-1, COX-2
Ibuprofen 2%	Ibuprofen 2%	Berlin-Chemie AG Menarini Group	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1, COX-2
Standard Dose Ibuprofen	Standard Dose Ibuprofen	Ottawa Hospital Research Institute	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1, COX-2
EC Aspirin 325	EC Aspirin 325	POZEN	marketed	Antiplatelet agent / NSAID	Cyclooxygenase (COX-1, COX-2)
Ibuprofen, Hydrocortisone	Ibuprofen, Hydrocortisone	X-pert Med GmbH	marketed	NSAID + corticosteroid combination	COX-1, COX-2, glucocorticoid receptor
Acetaminophen & Indomethacin	Acetaminophen & Indomethacin	Queen's University	marketed	Analgesic/Anti-inflammatory combination	COX-1, COX-2 (indomethacin); central nervous system analgesic pathways (acetaminophen)

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