High dose potent statin — Competitive Intelligence Brief

High dose potent statin (High dose potent statin) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: HMG-CoA reductase inhibitor (statin). Area: Cardiovascular.

marketed HMG-CoA reductase inhibitor (statin) HMG-CoA reductase Cardiovascular Small molecule

Target snapshot

High dose potent statin (High dose potent statin) — University of Florida. High-dose potent statins inhibit HMG-CoA reductase to reduce cholesterol synthesis and lower LDL cholesterol levels in the blood.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
High dose potent statin TARGET	High dose potent statin	University of Florida	marketed	HMG-CoA reductase inhibitor (statin)	HMG-CoA reductase
Crestor	rosuvastatin	AstraZeneca	marketed	HMG-CoA reductase inhibitor (statin)	HMG-CoA reductase	2003-01-01
Lipitor	atorvastatin	Pfizer Inc.	marketed	HMG-CoA reductase inhibitor (statin)	HMG-CoA reductase	1996-12-17
FLUVASTATIN SODIUM	FLUVASTATIN SODIUM		marketed		HMG-CoA reductase	1993-01-01
Lescol	FLUVASTATIN	Novartis	marketed	HMG-CoA Reductase Inhibitor	HMG-CoA reductase	1993-01-01
High dose Atorvastatin+enoxaparin	High dose Atorvastatin+enoxaparin	Hallym University Medical Center	marketed	Statin + Low-molecular-weight heparin combination	HMG-CoA reductase (atorvastatin); Factor IIa and Factor Xa (enoxaparin)
Ezetimibe 10/Simvastatin 20	Ezetimibe 10/Simvastatin 20	University Hospital Freiburg	marketed	Combination lipid-lowering agent (ezetimibe/statin)	NPC1L1 (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)

• 2037-06-07 — Lipitor · 11654106 · US
• 2037-06-07 — Lipitor · 11369567 · US

Sponsor landscape (HMG-CoA reductase inhibitor (statin) class)

1. Organon and Co · 7 drugs in this class
2. Kuhnil Pharmaceutical Co., Ltd. · 3 drugs in this class
3. Wenzhou Medical University · 2 drugs in this class
4. Amgen · 2 drugs in this class
5. Beijing Tiantan Hospital · 2 drugs in this class
6. Seoul National University Hospital · 2 drugs in this class
7. JW Pharmaceutical · 2 drugs in this class
8. AstraZeneca · 2 drugs in this class
9. Korea University Anam Hospital · 2 drugs in this class
10. Gachon University Gil Medical Center · 1 drug in this class