high-dose rosuvastatin single administration — Competitive Intelligence Brief

high-dose rosuvastatin single administration (high-dose rosuvastatin single administration) 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 rosuvastatin single administration (high-dose rosuvastatin single administration) — Korea University Anam Hospital. Rosuvastatin inhibits HMG-CoA reductase to reduce cholesterol synthesis and lower LDL cholesterol levels.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
high-dose rosuvastatin single administration TARGET	high-dose rosuvastatin single administration	Korea University Anam Hospital	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
Red Yeast Rice Pill	Red Yeast Rice Pill	Shiraz University of Medical Sciences	marketed	Statin (natural/herbal)	HMG-CoA reductase
Continue Ritonavir-boosted PI+Rosuvastatin	Continue Ritonavir-boosted PI+Rosuvastatin	Juan A. Arnaiz	marketed	Antiretroviral combination (protease inhibitor + statin)	HIV protease (PI component); HMG-CoA reductase (rosuvastatin 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