Alembic Pharmaceuticals Secures FDA Approval for Generic Prucalopride Tablets
The U.S. FDA granted final approval to Alembic Pharmaceuticals for its generic version of Motegrity, a serotonin-4 receptor agonist. The drug targets the chronic idiopathic constipation market, which is valued at approximately $100 million.
Regulatory Milestone for Chronic Constipation Treatment
Alembic Pharmaceuticals announced on Tuesday, July 28, 2026, that the U.S. Food and Drug Administration (FDA) has issued final approval for its abbreviated new drug application (ANDA) regarding Prucalopride Tablets. Available in 1 mg and 2 mg strengths, this medication serves as a therapeutic equivalent to Takeda Pharmaceuticals USA Inc.’s branded product, Motegrity.
Market Potential and Therapeutic Mechanism
Prucalopride functions as a serotonin-4 receptor agonist specifically indicated for adults suffering from chronic idiopathic constipation (CIC). Data from IQVIA suggests a significant commercial opportunity for this generic entry. Alembic notes that the annual market for this specific treatment reached an estimated value of $100 million during the twelve-month period ending in March 2026.
- Drug Class: Serotonin-4 receptor agonist
- Dosage Forms: 1 mg and 2 mg tablets
- Target Condition: Chronic idiopathic constipation (CIC)
- Reference Drug: Motegrity (Takeda Pharmaceuticals USA Inc.)
Source: The Hindu — Business
