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Diclofenac Capsules high dose — Competitive Intelligence Brief
phase 2
NSAID
COX-2
Rheumatology
Small molecule
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Target snapshot
Diclofenac Capsules high dose (Diclofenac Capsules high dose) — Iroko Pharmaceuticals, LLC. Diclofenac 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 |
|---|---|---|---|---|---|---|
| Diclofenac Capsules high dose TARGET | Diclofenac Capsules high dose | Iroko Pharmaceuticals, LLC | phase 2 | 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 |
| Diclofenac + Omeprazole | Diclofenac + Omeprazole | Pfizer's Upjohn has merged with Mylan to form Viatris Inc. | marketed | NSAID + Proton pump inhibitor combination | COX-1/COX-2 (diclofenac); H+/K+-ATPase (omeprazole) | |
| Parestat(generic parecoxib) | Parestat(generic parecoxib) | University of Malaya | marketed | Selective COX-2 inhibitor (coxib) | COX-2 (Cyclooxygenase-2) | |
| sumatriptan succinate/naproxen sodium | sumatriptan succinate/naproxen sodium | GlaxoSmithKline | marketed | 5-HT1B/1D receptor agonist combined with NSAID | 5-HT1B receptor, 5-HT1D receptor, COX-1, COX-2 | |
| acetaminophen/codeine and ibuprofen | acetaminophen/codeine and ibuprofen | University of California, Davis | marketed | Combination analgesic (opioid + NSAID + acetaminophen) | Mu opioid receptor (codeine); COX-1/COX-2 (ibuprofen); unclear (acetaminophen) |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
- — Celebrex · 10722456 · Formulation · US
- — Celebrex · 10799517 · Formulation · US
- — Celebrex · 9949990 · Formulation · US
- — Celebrex · 9795620 · Formulation · US
- — Celebrex · 9572819 · Formulation · US
- — Celebrex · 10376527 · Formulation · US
Sponsor landscape (NSAID class)
- Antibe Therapeutics Inc. · 3 drugs in this class
- Iroko Pharmaceuticals, LLC · 3 drugs in this class
- Organon and Co · 2 drugs in this class
- Apsen Farmaceutica S.A. · 2 drugs in this class
- Amneal Pharmaceuticals, LLC · 2 drugs in this class
- Behar, Caren, M.D. · 2 drugs in this class
- IDEA AG · 2 drugs in this class
- Noven Pharmaceuticals, Inc. · 2 drugs in this class
- HALEON · 2 drugs in this class
- Pfizer · 2 drugs in this class
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Cite this brief
Drug Landscape (2026). Diclofenac Capsules high dose — Competitive Intelligence Brief. https://druglandscape.com/ci/diclofenac-capsules-high-dose. Accessed 2026-05-16.
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