Livalo — Competitive Intelligence Brief

Livalo (PITAVASTATIN) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: HMG-CoA Reductase Inhibitor. Area: Metabolic.

marketed HMG-CoA Reductase Inhibitor 3-hydroxy-3-methylglutaryl-coenzyme A reductase Metabolic Small molecule

Target snapshot

Livalo (PITAVASTATIN) — Kowa Co.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Livalo TARGET	PITAVASTATIN	Kowa Co	marketed	HMG-CoA Reductase Inhibitor	3-hydroxy-3-methylglutaryl-coenzyme A reductase	2009-01-01
Baycol	CERIVASTATIN	Bayer	marketed	cerivastatin	3-hydroxy-3-methylglutaryl-coenzyme A reductase	1997-01-01
Lipitor	Atorvastatin Calcium	Pfizer	marketed	atorvastatin	3-hydroxy-3-methylglutaryl-coenzyme A reductase	1996-01-01
Mevacor	LOVASTATIN	Merck & Co.	marketed	HMG-CoA Reductase Inhibitor	3-hydroxy-3-methylglutaryl-coenzyme A reductase	1987-01-01
Zocor	simvastatin	Merck & Co.	marketed	HMG-CoA Reductase Inhibitor [EPC]	Nuclear receptor subfamily 1 group I member 3, Nuclear receptor subfamily 4 group A member 2, 3-hydroxy-3-methylglutaryl-coenzyme A reductase
PITAVASTATIN MAGNESIUM	PITAVASTATIN MAGNESIUM		marketed	HMG-CoA Reductase Inhibitor [EPC]	3-hydroxy-3-methylglutaryl-coenzyme A (HMG-CoA) reductase	2017-01-01
Crestor	rosuvastatin	AstraZeneca	marketed	HMG-CoA reductase inhibitor (statin)	HMG-CoA reductase	2003-01-01

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)

• 2027-04-26 — Zocor · 10300041 · Formulation · US
• 2030-02-23 — Zocor · 9597289 · Formulation · US
• 2037-06-07 — Lipitor · 11654106 · US
• 2037-06-07 — Lipitor · 11369567 · US

Sponsor landscape (HMG-CoA Reductase Inhibitor class)

1. Kowa Co · 1 drug in this class
2. Merck & Co. · 1 drug in this class
3. Novartis · 1 drug in this class