Pitavastatin (NK-104) — Competitive Intelligence Brief

Pitavastatin (NK-104) (Pitavastatin (NK-104)) 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

Pitavastatin (NK-104) (Pitavastatin (NK-104)) — Kowa Research Institute, Inc.. Pitavastatin inhibits HMG-CoA reductase, the rate-limiting enzyme in cholesterol synthesis, thereby reducing LDL cholesterol levels.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Pitavastatin (NK-104) TARGET	Pitavastatin (NK-104)	Kowa Research Institute, Inc.	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
Rosuvastatin-pantoprazole	Rosuvastatin-pantoprazole	Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec	marketed	Statin + proton pump inhibitor combination	HMG-CoA reductase (rosuvastatin); H+/K+-ATPase (pantoprazole)
Atorvastatin-omeprazole	Atorvastatin-omeprazole	Centre de Recherche de l'Institut Universitaire de Cardiologie et de Pneumologie de Quebec	marketed	Fixed-dose combination (statin + proton pump inhibitor)	HMG-CoA reductase (atorvastatin); H+/K+-ATPase (omeprazole)

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