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Ambelvist

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.

The information outlined in the molecule details section below would help you evaluate Para IV filing opportunities early to secure a first-to-file advantage.

Molecule Details :

  • Molecule Name :

    Gadoquatrane
  • Innovator :

    BAYER HEALTHCARE
  • Approval Date :

    12-Jun-26
  • NCE-1 Date :

    12-Jun-30
  • NCE Date :

    12-Jun-31
  • Dosage Form :

    Intravenous Solution
  • Strength :

    0.5158GM/2ML (257.9MG/ML), 1.93425GM/7.5ML (257.9MG/ML), 2.579GM/10ML (257.9MG/ML), 3.8685GM/15ML (257.9MG/ML), 7.737GM/30ML (257.9MG/ML), 16.7635GM/65ML (257.9MG/ML)
  • Therapeutic Category :

    Paramagnetic Contrast Agent
  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    NA
  • 2026 :

    NA
  • 2027 :

    NA
  • 2028 :

    NA
  • 2029 :

    NA
  • 2030 :

    NA
  • 2031 :

    NA
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