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Duvyzat

Duvyzat is an oral histone deacetylase inhibitor prescribed for Duchenne muscular dystrophy in patients aged six and older. It slows muscle degeneration, reduces inflammation, and supports muscle strength by modulating gene regulation processes.

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 :

    Givinostat
  • Innovator :

    ITALFARMACO SPA
  • Approval Date :

    21-Mar-24
  • NCE-1 Date :

    21-Mar-28
  • NCE Date :

    21-Mar-29
  • Dosage Form :

    Oral Suspension
  • Strength :

    EQ 8.86MG BASE/ML
  • Therapeutic Category :

    Neuromuscular Agents
  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    363
  • 2026 :

    393
  • 2027 :

    432
  • 2028 :

    484
  • 2029 :

    543
  • 2030 :

    600
  • 2031 :

    NA
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