[F-18]Florastamin — Competitive Intelligence Brief

[F-18]Florastamin ([F-18]Florastamin) 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

[F-18]Florastamin ([F-18]Florastamin) — FutureChem. Florastatin is a radiolabeled version of florastatin, a statin used to lower cholesterol levels.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
[F-18]Florastamin TARGET	[F-18]Florastamin	FutureChem	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
HMG-CoA Reductase Inhibitor	HMG-CoA Reductase Inhibitor	Seoul National University Hospital	marketed	HMG-CoA reductase inhibitor (statin)	HMG-CoA reductase
Rosuvastatin (Crestor)	Rosuvastatin (Crestor)	Minneapolis Heart Institute Foundation	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