Vehicle Diclofenac Sodium Topical Gel — Competitive Intelligence Brief

Vehicle Diclofenac Sodium Topical Gel (Vehicle Diclofenac Sodium Topical Gel) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: NSAID. Area: Pain Management.

phase 3 NSAID COX-2 Pain Management Small molecule

Target snapshot

Vehicle Diclofenac Sodium Topical Gel (Vehicle Diclofenac Sodium Topical Gel) — Amneal Pharmaceuticals, LLC. Diclofenac sodium works by inhibiting the enzyme cyclooxygenase (COX), which is involved in the production of prostaglandins, leading to reduced inflammation and pain.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Vehicle Diclofenac Sodium Topical Gel TARGET	Vehicle Diclofenac Sodium Topical Gel	Amneal Pharmaceuticals, LLC	phase 3	NSAID	COX-2
Celebrex	celecoxib	Pfizer Inc. (originally Searle/Pharmacia)	marketed	Nonsteroidal Anti-inflammatory Drug [EPC]	COX-2	1998-12-31
Cytotec	Misoprostol	Pfizer	marketed	NSAID combined with prostaglandin analog	Cyclooxygenase (COX-1 and COX-2); Prostaglandin receptors	1988-01-01
Ibuprofen Tablets	Ibuprofen Tablets	Overseas Pharmaceuticals, Ltd.	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1 and COX-2
Acetaminophen & Indomethacin	Acetaminophen & Indomethacin	Queen's University	marketed	Analgesic/Anti-inflammatory combination	COX-1, COX-2 (indomethacin); central nervous system analgesic pathways (acetaminophen)
Topical Diclofenac gel 1%	Topical Diclofenac gel 1%	University of California, Davis	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	COX-1 and COX-2
Diclofenac Sodium Topical Gel, 1%	Diclofenac Sodium Topical Gel, 1%	Amneal Pharmaceuticals, LLC	marketed	Nonsteroidal anti-inflammatory drug (NSAID)	Cyclooxygenase-1 (COX-1) and Cyclooxygenase-2 (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)

• 2036-05-27 — Celebrex · 10722456 · Formulation · US
• 2036-05-27 — Celebrex · 10799517 · Formulation · US
• 2036-05-27 — Celebrex · 9949990 · Formulation · US
• 2036-05-27 — Celebrex · 9795620 · Formulation · US
• 2036-05-27 — Celebrex · 9572819 · Formulation · US
• 2036-05-27 — Celebrex · 10376527 · Formulation · US

Sponsor landscape (NSAID class)

1. Antibe Therapeutics Inc. · 3 drugs in this class
2. Iroko Pharmaceuticals, LLC · 3 drugs in this class
3. Organon and Co · 2 drugs in this class
4. Apsen Farmaceutica S.A. · 2 drugs in this class
5. Amneal Pharmaceuticals, LLC · 2 drugs in this class
6. Behar, Caren, M.D. · 2 drugs in this class
7. IDEA AG · 2 drugs in this class
8. Noven Pharmaceuticals, Inc. · 2 drugs in this class
9. HALEON · 2 drugs in this class
10. Pfizer · 2 drugs in this class