ANI Pharmaceuticals Launches Pimozide Tablets with 180-Day Exclusivity and $3.1M Market
ANI Pharmaceuticals received FDA approval for generic Pimozide Tablets 1 mg and 2 mg and launched them with 180-day CGT exclusivity. U.S. annual sales for pimozide tablets total approximately $3.1 million based on February 2026 MAT data.
1. FDA Approval and Product Launch
ANI Pharmaceuticals secured FDA approval and began commercial shipments of Pimozide Tablets in 1 mg and 2 mg strengths. The launch marks the entry of a generic alternative to the reference listed drug Orap®.
2. 180-Day CGT Exclusivity
The product carries 180-day Competitive Generic Therapy (CGT) exclusivity, preventing other generics from entering the market during this period. This window allows ANI to capture initial market share without direct generic competition.
3. Market Sales Outlook
Based on February 2026 moving annual total data, U.S. pimozide tablet sales amount to roughly $3.1 million annually. The limited-competition launch offers a clear revenue stream to support broader generics growth.
4. Generics Business Strategy
This launch aligns with ANI’s strategy to introduce limited-competition products and expand its U.S.-based manufacturing footprint. The company aims to build on this exclusivity model to drive sustainable growth in its generics segment.