Delayed high-intensity statin — Competitive Intelligence Brief

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

phase 3 HMG-CoA reductase inhibitor (statin) HMG-CoA reductase Cardiovascular Small molecule

Target snapshot

Delayed high-intensity statin (Delayed high-intensity statin) — Beijing Tiantan Hospital. A statin formulation designed to achieve high-intensity lipid-lowering effects through delayed or modified release kinetics to reduce LDL cholesterol.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Delayed high-intensity statin TARGET	Delayed high-intensity statin	Beijing Tiantan Hospital	phase 3	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
Lescol	FLUVASTATIN	Novartis	marketed	HMG-CoA Reductase Inhibitor	HMG-CoA reductase	1993-01-01
FLUVASTATIN SODIUM	FLUVASTATIN SODIUM		marketed		HMG-CoA reductase	1993-01-01
High dose Rosuvastatin	High dose Rosuvastatin	Nanjing First Hospital, Nanjing Medical University	marketed	HMG-CoA reductase inhibitor (statin)	HMG-CoA reductase
Rosuvastatin-ranitidine	Rosuvastatin-ranitidine	Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec	marketed	Fixed-dose combination: HMG-CoA reductase inhibitor + H2-receptor antagonist	HMG-CoA reductase (rosuvastatin component); Histamine H2 receptor (ranitidine component)

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