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Ezetimibe + Simvastatin — Competitive Intelligence Brief
marketed
Combination lipid-lowering agent (ezetimibe + statin)
NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin)
Cardiovascular
Small molecule
Live · refreshed every 30 min
Target snapshot
Ezetimibe + Simvastatin (Ezetimibe + Simvastatin) — Organon and Co. Ezetimibe and simvastatin work together to lower cholesterol by blocking intestinal cholesterol absorption and inhibiting hepatic cholesterol synthesis.
Comparator set (5 drugs)
| Drug | Generic | Sponsor | Phase | Class | Target | Approval / PDUFA |
|---|---|---|---|---|---|---|
| Ezetimibe + Simvastatin TARGET | Ezetimibe + Simvastatin | Organon and Co | marketed | Combination lipid-lowering agent (ezetimibe + statin) | NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin) | |
| Ezetimibe and Simvastatin | Ezetimibe and Simvastatin | University of Texas Southwestern Medical Center | marketed | Combination lipid-lowering agent (ezetimibe + statin) | NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin) | |
| EZE/simvastatin | EZE/simvastatin | Azienda Ospedaliero Universitaria di Sassari | marketed | Combination lipid-lowering agent (ezetimibe + statin) | NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin) | |
| Comparator: ezetimibe and simvastatin | Comparator: ezetimibe and simvastatin | Organon and Co | phase 3 | Combination lipid-lowering agent (ezetimibe + statin) | NPC1L1 transporter (ezetimibe) and HMG-CoA reductase (simvastatin) | |
| Comparator: Placebo to ezetimibe/simvastatin | Comparator: Placebo to ezetimibe/simvastatin | Organon and Co | phase 3 | Combination lipid-lowering agent (ezetimibe + statin) | NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin) | |
| ezetimibe/simvastatin 10/40 | ezetimibe/simvastatin 10/40 | Organon and Co | phase 3 | Combination lipid-lowering agent (ezetimibe + statin) | NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin) |
Recent regulatory actions (last 90 days)
Upcoming PDUFA dates (next 180 days)
Patent timeline (forward window)
Sponsor landscape (Combination lipid-lowering agent (ezetimibe + statin) class)
- Organon and Co · 4 drugs in this class
- Azienda Ospedaliero Universitaria di Sassari · 1 drug in this class
- University of Texas Southwestern Medical Center · 1 drug in this class
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- Ezetimibe + Simvastatin CI watch — RSS
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Cite this brief
Drug Landscape (2026). Ezetimibe + Simvastatin — Competitive Intelligence Brief. https://druglandscape.com/ci/ezetimibe-simvastatin. Accessed 2026-05-13.
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