Diclofenac Cream 8% — Competitive Intelligence Brief

Diclofenac Cream 8% (Diclofenac Cream 8%) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Nonsteroidal anti-inflammatory drug (NSAID). Area: Pain Management, Rheumatology.

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

Target snapshot

Diclofenac Cream 8% (Diclofenac Cream 8%) — FPR Specialty Pharmacy. 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 topical application.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Diclofenac Cream 8% TARGET	Diclofenac Cream 8%	FPR Specialty Pharmacy	phase 3	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/acetaminophen	Ibuprofen/acetaminophen	Montefiore Medical Center	marketed	Analgesic/antipyretic combination (NSAID + non-NSAID analgesic)	Cyclooxygenase (COX-1, COX-2) for ibuprofen; prostaglandin synthesis and central pain pathways for acetaminophen
sumatriptan succinate/naproxen sodium	sumatriptan succinate/naproxen sodium	GlaxoSmithKline	marketed	5-HT1B/1D receptor agonist combined with NSAID	5-HT1B receptor, 5-HT1D receptor, COX-1, COX-2
Ibuprofen group	Ibuprofen group	University of Salamanca	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1, COX-2
Paracetamol + ibuprofen	Paracetamol + ibuprofen	Ullevaal University Hospital	marketed	Analgesic/antipyretic combination	COX-1, COX-2 (ibuprofen); prostaglandin synthesis pathway (paracetamol)
Non- effervescent Paracetamol kern	Non- effervescent Paracetamol kern	Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina	marketed	Analgesic and antipyretic	Cyclooxygenase (COX-1, 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