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NCE-1 Intelligence & Market Opportunity

Ambelvist

Gadoquatrane
Paramagnetic Contrast Agent
Intravenous Solution

Ambelvist is an FDA approved gadolinium-based contrast agent indicated for contrast-enhanced magnetic resonance imaging (MRI) to detect and visualize lesions with abnormal vascularity in the central nervous system and other body regions. As a next-generation, lower-dose MRI contrast agent, Ambelvist advances diagnostic imaging while supporting high-quality visualization across a broad range of clinical applications. For clinical trial and first-to-file teams, monitoring its market adoption, exclusivity timeline, and availability will be important, as it may become a relevant comparator in diagnostic imaging, radiology, and pharmaceutical development studies.

Approval Date
12-Jun-26
NCE-1 Date
12-Jun-30
NCE Date
12-Jun-31
Commercial snapshot

Market performance & projections

Revenue ($M)
NA
CAGR (%)
NA
Projected sales, 2026–2032 ($M)
Analyst projection, $M per year
2026
NA
2027
NA
2028
NA
2029
NA
2030
NA
2031
NA
2032
NA
Molecule profile

Details & specifications

Molecule
Gadoquatrane
Innovator
BAYER HEALTHCARE
Dosage Form
Intravenous Solution
Strength
0.5158 gm/2 mL (257.9 mg/mL), 1.93425 gm/7.5 mL (257.9 mg/mL), 2.579 gm/10 mL (257.9 mg/mL), 3.8685 gm/15 mL (257.9 mg/mL), 7.737 gm/30 mL (257.9 mg/mL), 16.7635 gm/65 mL (257.9 mg/mL)
Therapeutic Category
Paramagnetic Contrast Agent
Usage
To detect and visualize lesions with abnormal vascularity, in conjunction with MRI
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Frequently asked questions

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Intelligence you can file on

Verified regulatory data
Milestones tracked against primary FDA sources and refreshed continuously.
Analyst-built projections
Seven-year sales outlooks modeled by our pharma intelligence team.
First-to-file focus
Exclusivity windows framed around the decisions generics teams actually make.
Partnership on demand
From API sourcing to dossier support — one request starts the conversation.

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