Topical diclofenac sodium gel — Competitive Intelligence Brief

Topical diclofenac sodium gel (Topical diclofenac sodium gel) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nonsteroidal anti-inflammatory drug (NSAID). Area: Pain Management / Rheumatology.

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

Target snapshot

Topical diclofenac sodium gel (Topical diclofenac sodium gel) — Guang'anmen Hospital of China Academy of Chinese Medical Sciences. Diclofenac sodium inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain at the site of topical application.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Topical diclofenac sodium gel TARGET	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
aspirin + celecoxib	aspirin + celecoxib	Seoul National University Hospital	marketed	Nonsteroidal anti-inflammatory drug (NSAID) combination	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
morphine ,ketorolac	morphine ,ketorolac	Jose Antonio Bernia Gil	marketed	Opioid analgesic + NSAID combination	Opioid receptors (μ, δ, κ); COX-1 and COX-2 enzymes
Voltaren® Gel	Voltaren® Gel	Glenmark Pharmaceuticals Ltd. India	marketed	Topical NSAID	COX-1 and COX-2 enzymes
alpha-blocker and NSAID	alpha-blocker and NSAID	Samsung Medical Center	marketed	Alpha-blocker and NSAID combination	Alpha-1 adrenergic receptor; COX-1 and COX-2 enzymes
Ketoprofen Lysine Salt	Ketoprofen Lysine Salt	Dompé Farmaceutici S.p.A	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	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