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Indomethacin Capsules high dose — Competitive Intelligence Brief

Indomethacin Capsules high dose (Indomethacin Capsules high dose) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: NSAID. Area: Rheumatology.

phase 2 NSAID COX-1 and COX-2 Rheumatology Small molecule Live · refreshed every 30 min

Target snapshot

Indomethacin Capsules high dose (Indomethacin Capsules high dose) — Iroko Pharmaceuticals, LLC. Non-selective COX-1 and COX-2 inhibitor

Comparator set (6 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Indomethacin Capsules high dose TARGET Indomethacin Capsules high dose Iroko Pharmaceuticals, LLC phase 2 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
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)
Topical diclofenac sodium gel Topical diclofenac sodium gel Guang'anmen Hospital of China Academy of Chinese Medical Sciences marketed Nonsteroidal anti-inflammatory drug (NSAID) COX-1 and COX-2 enzymes
Bromfenac Sodium 0.07% Bromfenac Sodium 0.07% Retina Research Institute, LLC marketed Nonsteroidal anti-inflammatory drug (NSAID) 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
Ketorolac Nasal Spray Ketorolac Nasal Spray Hersh, Elliot V., DMD, MS, PhD 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 (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). Indomethacin Capsules high dose — Competitive Intelligence Brief. https://druglandscape.com/ci/indomethacin-capsules-high-dose. Accessed 2026-05-17.

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