ANI Pharmaceuticals Announces the FDA Approval and Launch of Pimozide Tablets with 180 Day CGT Exclusivity
ANI Pharmaceuticals has launched Pimozide Tablets in both 1 mg and 2 mg dosages, marking the introduction of a generic version of the reference listed drug Orap®. This launch comes with 180-Day CGT exclusivity, positioning ANI to capitalize on a market with annual sales estimated at $3.1 million as of February 2026, according to IQVIA data. Nikhil Lalwani, President and CEO of ANI, emphasized the company’s commitment to providing limited competition products that enhance access to essential therapeutics.
The significance of this launch extends beyond market dynamics; Pimozide is primarily indicated for the treatment of Tourette syndrome and other movement disorders, making it a valuable addition to the therapeutic arsenal for managing these conditions. By offering a generic alternative, ANI aims to improve patient access and affordability, particularly in the context of rising healthcare costs. The introduction of Pimozide Tablets also reflects ANI’s broader strategy to leverage its R&D capabilities and operational efficiencies within its Generics business, ensuring high-quality products are available to patients in need.
This development has notable implications for the field of longevity science and healthspan research, particularly in the context of drug development timelines. The successful launch of Pimozide Tablets may encourage further investment in the generics sector, potentially accelerating the availability of other essential medications that target age-related disorders. As ANI continues to navigate the complexities of regulatory environments and market competition, the outcomes of this launch could inform future strategies for developing and commercializing generic therapeutics, ultimately enhancing patient care in the longevity space.
Source: globenewswire.com