STOCKWATCH
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Pharmaceuticals
New Launch14 Nov 2025, 07:25 am

Lupin Launches Risperidone Long-Acting Injectable with 180-day CGT Exclusivity in the U.S.

AI Summary

Global pharma major Lupin Limited has announced the launch of Risperidone for extended-release injectable suspension, 25 mg per vial, 37.5 mg per vial, and 50 mg per vial, with 180-day CGT exclusivity in the U.S. This is the first product from its proprietary Long-Acting Injectable platform PrecisionSphere™. The product is bioequivalent and therapeutically equivalent to the reference listed drug Risperdal Consta® Long-Acting Injection, and is indicated for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar disorder in adults. Risperidone for extended-release injectable suspension (RLD Risperdal Consta®) has estimated sales of USD 187 million combined for 25 mg, 37.5 mg and 50 mg in the U.S.

Key Highlights

  • Lupin launched Risperidone for extended-release injectable suspension with 180-day CGT exclusivity in the U.S.
  • The product is the first from Lupin's proprietary Long-Acting Injectable platform PrecisionSphere™.
  • Risperidone for extended-release injectable suspension is bioequivalent and therapeutically equivalent to the reference listed drug Risperdal Consta® Long-Acting Injection.
  • The product is indicated for the treatment of schizophrenia in adults and as monotherapy or as adjunctive therapy to lithium or valproate for the maintenance treatment of bipolar disorder in adults.
  • Risperidone for extended-release injectable suspension (RLD Risperdal Consta®) has estimated sales of USD 187 million combined for 25 mg, 37.5 mg and 50 mg in the U.S.
LUPIN
Pharmaceuticals
LUPIN LTD.

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