Gadobutrol Injection — Competitive Intelligence Brief

Gadobutrol Injection (Gadobutrol Injection) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Gadolinium-based contrast agent. Area: Diagnostic Imaging.

phase 3 Gadolinium-based contrast agent Water protons (paramagnetic enhancement) Diagnostic Imaging Small molecule

Target snapshot

Gadobutrol Injection (Gadobutrol Injection) — Shanghai Shengdi Pharmaceutical Co., Ltd. Gadobutrol is a gadolinium-based contrast agent that accumulates in tissues and enhances magnetic resonance imaging (MRI) signal by shortening T1 relaxation time.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Gadobutrol Injection TARGET	Gadobutrol Injection	Shanghai Shengdi Pharmaceutical Co., Ltd	phase 3	Gadolinium-based contrast agent	Water protons (paramagnetic enhancement)
Gadavist	GADOBUTROL	Bayer	marketed	Gadolinium-based Contrast Agent [EPC]		2011-01-01
MultiHance 0.05 mmol/kg	MultiHance 0.05 mmol/kg	Bracco Diagnostics, Inc	marketed	Gadolinium-based contrast agent	Water proton relaxation (T1 relaxation enhancement)
Gadoteric Acid Meglumine Salt	Gadoteric Acid Meglumine Salt	The Central Hospital of Lishui City	marketed	Gadolinium-based contrast agent	Water proton relaxation (T1 relaxation time)
Gadoterate (Dotarem/Clariscan)	Gadoterate (Dotarem/Clariscan)	Bayer	marketed	Gadolinium-based contrast agent	Water protons (via paramagnetic gadolinium ion)
Gadopentetate-Dimeglumine 0.05 mmol	Gadopentetate-Dimeglumine 0.05 mmol	Paracelsus Medical University	marketed	Gadolinium-based contrast agent	Water protons (T1 relaxation enhancement)
Gadobutrol (Gadovist/Gadavist)	Gadobutrol (Gadovist/Gadavist)	Insel Gruppe AG, University Hospital Bern	marketed	Gadolinium-based contrast agent (GBCA)	Water proton relaxation (T1 relaxation enhancement)

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)

No upcoming patent expiries for this set.

Sponsor landscape (Gadolinium-based contrast agent class)

1. Guerbet · 4 drugs in this class
2. Bayer · 4 drugs in this class
3. Paracelsus Medical University · 2 drugs in this class
4. GE Healthcare · 1 drug in this class
5. Bracco Diagnostics, Inc · 1 drug in this class
6. Seoul National University Hospital · 1 drug in this class
7. Shanghai Shengdi Pharmaceutical Co., Ltd · 1 drug in this class
8. The Central Hospital of Lishui City · 1 drug in this class