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Topical, intra-oral ketoprofen gel — Competitive Intelligence Brief

Topical, intra-oral ketoprofen gel (Topical, intra-oral ketoprofen gel) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: NSAID. Area: Pain management.

phase 3 NSAID COX-1, COX-2 Pain management Small molecule Live · refreshed every 30 min

Target snapshot

Topical, intra-oral ketoprofen gel (Topical, intra-oral ketoprofen gel) — Behar, Caren, M.D.. Ketoprofen 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)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Topical, intra-oral ketoprofen gel TARGET Topical, intra-oral ketoprofen gel Behar, Caren, M.D. phase 3 NSAID COX-1, COX-2
Standard Dose Ibuprofen Standard Dose Ibuprofen Ottawa Hospital Research Institute marketed Nonsteroidal anti-inflammatory drug (NSAID) 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)
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)
optimized ibuprofen optimized ibuprofen OSF Healthcare System marketed Nonsteroidal anti-inflammatory drug (NSAID) COX-1, COX-2
Ibuprofen, Hydrocortisone Ibuprofen, Hydrocortisone X-pert Med GmbH marketed NSAID + corticosteroid combination COX-1, COX-2, glucocorticoid receptor
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

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 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

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Cite this brief

Drug Landscape (2026). Topical, intra-oral ketoprofen gel — Competitive Intelligence Brief. https://druglandscape.com/ci/topical-intra-oral-ketoprofen-gel. Accessed 2026-05-18.

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