Archive · 3 Sep 2025
Lupin Gets US FDA Approval for Generic Risperidone
Lupin, a pharmaceutical company, has received approval from the US FDA to sell a generic version of risperidone.
This medicine is an extended-release injectable suspension, meaning it's given as a shot that slowly releases the drug.
The shot is used to treat schizophrenia and bipolar disorder.
Lupin used technology from its subsidiary, Nanomi, to create this medicine.
This is the first product using Nanomi's technology and is expected to generate $190 million in annual sales in the US.
This will allow more access to this medicine.
Lupin Ltd. received US FDA approval for its generic risperidone.
The medicine is an extended-release injectable suspension.
It's used to treat schizophrenia and bipolar disorder.
Lupin's subsidiary, Nanomi, provided the technology.
The medicine has an estimated $190 million in annual sales in the US.
- Who
- Lupin Ltd
- What
- Received US FDA approval for generic risperidone
- When
- September 3, 2025
- Where
- In the US
- Why
- For the treatment and maintenance of schizophrenia and bipolar disorder
- Company
- Lupin Ltd
- Product
- Generic risperidone extended-release injectable suspension
- FDA Approval
- Yes
- Indications
- Schizophrenia and Bipolar Disorder
- Dosage Forms
- 25 mg, 37.5 mg, and 50 mg single-dose vials
- Technology Used
- Nanomi BV's (Nanomi) technology
- CGT Exclusivity
- 180 days
- Estimated Sales
- $190 million (annual)