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Skyclarys

Skyclarys is the first FDA-approved treatment for Friedreich’s ataxia in patients aged 16 years and older. It helps reduce physical impairment associated with the 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 :

    Omaveloxolone
  • Innovator :

    REATA PHARMACEUTICALS INC
  • Approval Date :

    28-Feb-23
  • NCE-1 Date :

    28-Feb-27
  • NCE Date :

    28-Feb-28
  • Dosage Form :

    Capsule
  • Strength :

    50mg
  • Therapeutic Category :

    Neuroprotective
  • Revenue ($M) :

    383

Year-wise Projected Sales ($M) :

  • 2025 :

    526
  • 2026 :

    672
  • 2027 :

    791
  • 2028 :

    908
  • 2029 :

    1,014
  • 2030 :

    1,089
  • 2031 :

    1,148
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