Diclofenac Sodium Topical Gel, 1% — Competitive Intelligence Brief

Diclofenac Sodium Topical Gel, 1% (Diclofenac Sodium Topical Gel, 1%) 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) Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (COX-2) Pain Management / Rheumatology Small molecule

Target snapshot

Diclofenac Sodium Topical Gel, 1% (Diclofenac Sodium Topical Gel, 1%) — Amneal Pharmaceuticals, LLC. 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
Diclofenac Sodium Topical Gel, 1% TARGET	Diclofenac Sodium Topical Gel, 1%	Amneal Pharmaceuticals, LLC	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (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
Ketoprofen Lysine Salt	Ketoprofen Lysine Salt	Dompé Farmaceutici S.p.A	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1 and COX-2
Indomethacin suppository	Indomethacin suppository	Azienda USL Reggio Emilia - IRCCS	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1 and COX-2
Nerkardou (5 mg) & (10 mg)	Nerkardou (5 mg) & (10 mg)	Genuine Research Center, Egypt	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-2
Prednisone and Aspirin	Prednisone and Aspirin	Second Affiliated Hospital, School of Medicine, Zhejiang University	marketed	Corticosteroid and nonsteroidal anti-inflammatory drug (NSAID) combination	Glucocorticoid receptor (prednisone); Cyclooxygenase-1 and Cyclooxygenase-2 (aspirin)
Aspirin 81 enteric coated tablet daily	Aspirin 81 enteric coated tablet daily	University of Florida	marketed	Antiplatelet agent / Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase-1 (COX-1)

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