[18F]Florastamin Injection — Competitive Intelligence Brief

[18F]Florastamin Injection ([18F]Florastamin Injection) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: statin. Area: Cardiovascular.

phase 3 statin HMG-CoA reductase Cardiovascular Small molecule

Target snapshot

[18F]Florastamin Injection ([18F]Florastamin Injection) — HTA Co., Ltd.. Florastatin is a radiolabeled version of florastatine, a statin used to lower cholesterol levels.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
[18F]Florastamin Injection TARGET	[18F]Florastamin Injection	HTA Co., Ltd.	phase 3	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
EZE/simvastatin	EZE/simvastatin	Azienda Ospedaliero Universitaria di Sassari	marketed	Combination lipid-lowering agent (ezetimibe + statin)	NPC1L1 transporter (ezetimibe); HMG-CoA reductase (simvastatin)
Rosuvastatin(Cresnon®)	Rosuvastatin(Cresnon®)	Dong-A ST Co., Ltd.	marketed	HMG-CoA reductase inhibitor (statin)	HMG-CoA reductase

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 (statin class)

1. FutureChem · 1 drug in this class
2. HTA Co., Ltd. · 1 drug in this class
3. Merck Sharp & Dohme LLC · 1 drug in this class
4. VA Office of Research and Development · 1 drug in this class
5. Zhejiang Hisun Pharmaceutical Co. Ltd. · 1 drug in this class