Voltaren Topical Gel, 1% — Competitive Intelligence Brief

Voltaren Topical Gel, 1% (Voltaren Topical Gel, 1%) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: NSAID. Area: Musculoskeletal.

phase 3 NSAID COX Musculoskeletal Small molecule

Target snapshot

Voltaren Topical Gel, 1% (Voltaren Topical Gel, 1%) — Amneal Pharmaceuticals, LLC. Voltaren Topical Gel, 1% works by reducing inflammation and pain through the inhibition of prostaglandin synthesis.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Voltaren Topical Gel, 1% TARGET	Voltaren Topical Gel, 1%	Amneal Pharmaceuticals, LLC	phase 3	NSAID	COX
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
Paracetamol-Tramadol	Paracetamol-Tramadol	Astes	marketed	Analgesic combination (non-opioid + opioid)	Cyclooxygenase (COX), opioid receptors (μ, δ, κ), norepinephrine transporter, serotonin transporter
Ketorolac + Ranibizumab	Ketorolac + Ranibizumab	Università degli Studi di Brescia	marketed	NSAID + anti-VEGF monoclonal antibody fragment	COX enzymes (ketorolac); VEGF-A (ranibizumab)
Ropivacaine Ketorolac	Ropivacaine Ketorolac	University of Aarhus	marketed	Local anesthetic + NSAID combination	Voltage-gated sodium channels (ropivacaine); COX-1/COX-2 (ketorolac)
ASA	ASA	Biogen	marketed	Nonsteroidal anti-inflammatory drug (NSAID); antiplatelet agent	Cyclooxygenase-1 (COX-1); 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