Atorvastatin (generic Lipitor) — Competitive Intelligence Brief

Atorvastatin (generic Lipitor) (Atorvastatin (generic Lipitor)) 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

Atorvastatin (generic Lipitor) (Atorvastatin (generic Lipitor)) — University of Pennsylvania. Atorvastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels in the blood.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Atorvastatin (generic Lipitor) TARGET	Atorvastatin (generic Lipitor)	University of Pennsylvania	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
Diet+pravastatin	Diet+pravastatin	Mitsukoshi Health and Welfare Foundation	marketed	Statin (HMG-CoA reductase inhibitor)	HMG-CoA reductase
EZE/simvastatin	EZE/simvastatin	Azienda Ospedaliero Universitaria di Sassari	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