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Comparator: ezetimibe and simvastatin — Competitive Intelligence Brief

Comparator: ezetimibe and simvastatin (Comparator: ezetimibe and simvastatin) competitive landscape: 5 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Combination lipid-lowering agent (ezetimibe + statin). Area: Cardiovascular.

phase 3 Combination lipid-lowering agent (ezetimibe + statin) NPC1L1 transporter (ezetimibe) and HMG-CoA reductase (simvastatin) Cardiovascular Small molecule Live · refreshed every 30 min

Target snapshot

Comparator: ezetimibe and simvastatin (Comparator: ezetimibe and simvastatin) — Organon and Co. This is a fixed-dose combination of ezetimibe (which blocks cholesterol absorption in the intestine) and simvastatin (which inhibits HMG-CoA reductase to reduce cholesterol synthesis), working synergistically to lower LDL cholesterol.

Comparator set (5 drugs)

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DrugGenericSponsorPhaseClassTargetApproval / PDUFA
Comparator: ezetimibe and simvastatin TARGET Comparator: ezetimibe and simvastatin Organon and Co phase 3 Combination lipid-lowering agent (ezetimibe + statin) NPC1L1 transporter (ezetimibe) and 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)
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)
Ezetimibe + Simvastatin Ezetimibe + Simvastatin Organon and Co marketed 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)
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)

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 (Combination lipid-lowering agent (ezetimibe + statin) class)

  1. Organon and Co · 4 drugs in this class
  2. Azienda Ospedaliero Universitaria di Sassari · 1 drug in this class
  3. University of Texas Southwestern Medical Center · 1 drug in this class

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Cite this brief

Drug Landscape (2026). Comparator: ezetimibe and simvastatin — Competitive Intelligence Brief. https://druglandscape.com/ci/comparator-ezetimibe-and-simvastatin. Accessed 2026-05-16.

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