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Dawnzera

Dawnzera is an RNA-targeted antisense oligonucleotide indicated for prophylaxis to prevent attacks of hereditary angioedema (HAE) in patients aged 12 years and older. It works by selectively reducing prekallikrein production, thereby lowering bradykinin formation, to significantly reduce the frequency and severity of swelling episodes. The drug is administered via a subcutaneous autoinjector every 4 weeks, offering a convenient self-injectable prophylactic option for this serious condition.

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 :

    Donidalorsen
  • Innovator :

    IONIS PHARMACEUTICALS, INC
  • Approval Date :

    21-Aug-25
  • NCE-1 Date :

    21-Aug-29
  • NCE Date :

    21-Aug-30
  • Dosage Form :

    Injection
  • Strength :

    80MG
  • Therapeutic Category :

    Hereditary Angioedema Agents
  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    15
  • 2026 :

    77
  • 2027 :

    168
  • 2028 :

    261
  • 2029 :

    331
  • 2030 :

    401
  • 2031 :

    470
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