Topical Diclofenac gel 1% — Competitive Intelligence Brief

Topical Diclofenac gel 1% (Topical Diclofenac gel 1%) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nonsteroidal anti-inflammatory drug (NSAID). Area: Rheumatology / Pain Management.

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

Target snapshot

Topical Diclofenac gel 1% (Topical Diclofenac gel 1%) — University of California, Davis. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain at the site of application.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Topical Diclofenac gel 1% TARGET	Topical Diclofenac gel 1%	University of California, Davis	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
Bromfenac Ophthalmic Solution B	Bromfenac Ophthalmic Solution B	Bausch & Lomb Incorporated	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1 and COX-2)
Tinoridine HCl	Tinoridine HCl	Takeda	marketed	Non-steroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1 and COX-2)
Prolensa 0.07% Ophthalmic Solution	Prolensa 0.07% Ophthalmic Solution	Nicole Fram M.D.	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1 and COX-2)
aspirin and [NSAID]	aspirin and [NSAID]	POZEN	marketed	NSAID combination	Cyclooxygenase (COX-1 and COX-2)
Voltaren® Gel	Voltaren® Gel	Glenmark Pharmaceuticals Ltd. India	marketed	Topical NSAID	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