AMZ001 Diclofenac gel — Competitive Intelligence Brief

AMZ001 Diclofenac gel (AMZ001 Diclofenac gel) 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 and COX-2 Pain Management / Rheumatology Small molecule

Target snapshot

AMZ001 Diclofenac gel (AMZ001 Diclofenac gel) — Amzell. Diclofenac is a nonsteroidal anti-inflammatory drug (NSAID) that inhibits cyclooxygenase (COX) enzymes to reduce prostaglandin synthesis, thereby decreasing inflammation and pain.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
AMZ001 Diclofenac gel TARGET	AMZ001 Diclofenac gel	Amzell	phase 3	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
Multiple-Visit-"Corticosteroid Paste"	Multiple-Visit-"Corticosteroid Paste"	Istanbul Medipol University Hospital	marketed	Nonsteroidal Anti-inflammatory Drug [EPC]	cyclooxygenase (COX-1 and COX-2)
ABS	ABS	Teva Branded Pharmaceutical Products R&D, Inc.	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1 and COX-2
ropivacaine and ketorolac	ropivacaine and ketorolac	University of Aarhus	marketed	Local anesthetic + NSAID combination	Voltage-gated sodium channels (ropivacaine); COX-1 and COX-2 (ketorolac)
Ropivacaine, Ketorolac and Adrenaline	Ropivacaine, Ketorolac and Adrenaline	University of Aarhus	marketed	Local anesthetic combination with NSAID and vasopressor	Voltage-gated sodium channels (ropivacaine); COX-1 and COX-2 (ketorolac); alpha and beta adrenergic receptors (adrenaline)
Ketorolac Ophthalmic Solution	Ketorolac Ophthalmic Solution	Bausch & Lomb Incorporated	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase (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