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Orserdu

Orserdu is a once-daily selective estrogen receptor degrader (SERD) approved for ER-positive, HER2-negative, ESR1-mutated, advanced or metastatic breast cancer in adults after endocrine therapy.

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 :

    Elacestrant
  • Innovator :

    STEMLINE THERAPEUTICS INC
  • Approval Date :

    27-Jan-23
  • NCE-1 Date :

    27-Jan-27
  • NCE Date :

    27-Jan-28
  • Dosage Form :

    Tablet
  • Strength :

    EQ 86MG BASE,EQ 345MG BASE
  • Therapeutic Category :

    Hormonal Therapy
  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2025 :

    6
  • 2026 :

    28
  • 2027 :

    58
  • 2028 :

    98
  • 2029 :

    139
  • 2030 :

    174
  • 2031 :

    212
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