Diclofenac diethylamine 1.16% gel — Competitive Intelligence Brief

Diclofenac diethylamine 1.16% gel (Diclofenac diethylamine 1.16% gel) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: NSAID (nonsteroidal anti-inflammatory drug). Area: Pain Management, Rheumatology.

marketed NSAID (nonsteroidal anti-inflammatory drug) COX-1, COX-2 Pain Management, Rheumatology Small molecule

Target snapshot

Diclofenac diethylamine 1.16% gel (Diclofenac diethylamine 1.16% gel) — Novartis. Diclofenac 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
Diclofenac diethylamine 1.16% gel TARGET	Diclofenac diethylamine 1.16% gel	Novartis	marketed	NSAID (nonsteroidal anti-inflammatory drug)	COX-1, COX-2
Pranoprofen Eyedrops	Pranoprofen Eyedrops	Università degli Studi di Brescia	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1, COX-2)
naproxen sodium codein	naproxen sodium codein	Diskapi Yildirim Beyazit Education and Research Hospital	marketed	NSAID + opioid combination analgesic	COX-1, COX-2, mu opioid receptor
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
Pranoprofen eye drops	Pranoprofen eye drops	Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (COX-1, COX-2)
Codeine paracetamol	Codeine paracetamol	Napp Pharmaceuticals Limited	marketed	Opioid analgesic combination	Opioid receptors (μ, δ, κ); cyclooxygenase (COX-1, COX-2)
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

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 (NSAID (nonsteroidal anti-inflammatory drug) class)

1. Depomed · 1 drug in this class
2. Dong-A ST Co., Ltd. · 1 drug in this class
3. Handok Inc. · 1 drug in this class
4. Imprimis Pharmaceuticals, Inc. · 1 drug in this class
5. Kunming Baker Norton Pharmaceutical Sales Co., Ltd. · 1 drug in this class
6. LEO Pharma · 1 drug in this class
7. Novartis · 1 drug in this class
8. Pfizer · 1 drug in this class
9. University of South Alabama · 1 drug in this class
10. ZARS Pharma Inc. · 1 drug in this class