Placebo to Atorvastatin — Competitive Intelligence Brief

Placebo to Atorvastatin (Placebo to Atorvastatin) 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

Placebo to Atorvastatin (Placebo to Atorvastatin) — Amgen. This is a Phase 3 trial comparing placebo to atorvastatin, a statin that lowers cholesterol by inhibiting HMG-CoA reductase.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Placebo to Atorvastatin TARGET	Placebo to Atorvastatin	Amgen	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
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
Atorvastatin, Amlodipine, Perindopril	Atorvastatin, Amlodipine, Perindopril	Charles University, Czech Republic	marketed	Fixed-dose combination: statin, calcium channel blocker, ACE inhibitor	HMG-CoA reductase (atorvastatin); L-type calcium channels (amlodipine); Angiotensin-converting enzyme (perindopril)
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)

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