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Beyfortus

Beyfortus is a single-dose antibody given to newborns and infants to prevent serious RSV (respiratory syncytial virus) lung infections during their first two RSV seasons. It reduces hospitalizations by about 70 to 80%.

The information outlined in the molecule details section below would help you plan aBLA development early to enable a streamlined and competitive biosimilar strategy.

Molecule Details :

  • Molecule Name :

    Nirsevimab-Alip
  • Innovator :

    SANOFI
  • Approval Date :

    17-Jul-23
  • Data Exclusivity Expiry :

    17-Jul-27
  • Market Exclusivity Expiry :

    17-Jul-35
  • Dosage Form :

    Intramuscular Injection
  • Strength :

    100mg/ 1ml and 50mg/ 0.5ml
  • Therapeutic Category :

    Antiviral
  • Revenue ($M) :

    2,346

Year-wise Projected Sales ($M) :

  • 2025 :

    2,606
  • 2026 :

    2,914
  • 2027 :

    3,168
  • 2028 :

    3,382
  • 2029 :

    3,536
  • 2030 :

    3,699
  • 2031 :

    3,862
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