ANI Pharmaceuticals (NASDAQ:ANIP) announced today the U.S. Food and Drug Administration (FDA) approval and commercial launch of Pimozide Tablets in 1 mg and 2 mg strengths.
The product is the therapeutic generic equivalent of Orap®, an antipsychotic medication primarily indicated for the suppression of motor and phonic tics in patients with Tourette’s Disorder.
A significant aspect of the approval is the designation of 180-day Competitive Generic Therapy (CGT) exclusivity.
This regulatory status prevents the FDA from approving other generic versions of pimozide for a six-month period, granting ANI Pharmaceuticals a period of limited competition to establish its market presence.
According to February 2026 MAT IQVIA data, annual U.S. sales for Pimozide Tablets are approximately $3.1 million.
While the market size is specialized, the CGT exclusivity allows ANI to capture a substantial portion of that value by operating as the primary generic provider during the exclusive window.
The introduction of pimozide follows ANI’s broader initiative to expand its generics portfolio through high-barrier-to-entry products.
By focusing on medications with complex manufacturing requirements or smaller patient bases, the company aims to avoid the heavy price erosion often seen in "blockbuster" generic markets.