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Lipfendra

PCSK9 inhibitors have transformed cholesterol management, but until now they have largely depended on injections. Lipfendra (enlicitide decanoate) changes that by becoming the first FDA-approved oral PCSK9 inhibitor for lowering LDL cholesterol.

The therapy works by blocking PCSK9, allowing more LDL receptors to remain active on the liver and clear harmful cholesterol from the bloodstream. Delivering this mechanism in a once-daily tablet could improve convenience and potentially increase patient adherence.

As cardiovascular treatment continues to evolve, Lipfendra is likely to become an important benchmark in lipid-management studies. Tracking its commercial adoption and exclusivity period will help clinical trial and regulatory teams stay ahead of emerging opportunities.

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 :

    Enlicitide Decanoate
  • Innovator :

    MERCK SHARP AND DOHME LLC
  • Approval Date :

    15-Jul-26
  • NCE-1 Date :

    15-Jul-30
  • NCE Date :

    15-Jul-31
  • Dosage Form :

    Oral Tablet
  • Strength :

    EQ 20MG BASE
  • Therapeutic Category :

    Oral PCSK9 Inhibitor
  • Revenue ($M) :

    NA

Year-wise Projected Sales ($M) :

  • 2026 :

    18
  • 2027 :

    305
  • 2028 :

    667
  • 2029 :

    1346
  • 2030 :

    2096
  • 2031 :

    2781
  • 2032 :

    3488
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