ANI Pharmaceuticals' Prucalopride Tablets: A Game Changer in Chronic Constipation Treatment

PRINCETON, N.J., Jan. 02, 2025 (GLOBE NEWSWIRE) -- ANI Pharmaceuticals, Inc. (ANI or the Company) (Nasdaq: ANIP) today announced a significant milestone in the treatment of chronic constipation with the FDA approval and launch of Prucalopride Tablets. This generic version of the reference listed drug (RLD) Motegrity® comes with a Competitive Generic Therapy (CGT) designation and 180-day exclusivity, positioning ANI to capture a substantial portion of the market.

The U.S. annual sales for Prucalopride Tablets total approximately $168.0 million, based on October 2024 moving annual total (MAT) IQVIA data. With the CGT exclusivity, ANI is expected to secure around 50-60% market share during the first half of 2025, generating approximately $40-50 million in revenue. This represents a significant growth opportunity for ANI, whose current market cap is $1.16 billion.

Prucalopride Tablets' mechanism as a selective serotonin type 4 receptor agonist offers an important alternative in the constipation therapy landscape. The exclusivity period provides ANI with a crucial window to establish market presence, build relationships with healthcare providers and pharmacy benefit managers, and drive rapid adoption of this more affordable alternative. The successful development of this complex generic further validates ANI's R&D capabilities and positions them favorably for future complex generic approvals.