ANI Pharmaceuticals announced the launch of a generic version of the antipsychotic drug Pimozide, marketed under the brand name Orap. The new product is available in 1 mg and 2 mg tablet strengths and carries a 180‑day Competitive Generic Therapy (CGT) exclusivity period, giving the company a temporary monopoly on sales in the United States.
Projected U.S. annual sales for the new Pimozide tablets are approximately $3.1 million, based on February 2026 moving‑annual‑total IQVIA data. While modest compared with ANI’s overall revenue, the launch expands the company’s generics portfolio and provides a new cash‑generating source that complements its rapidly growing rare‑disease franchise.
The decision to launch Pimozide aligns with ANI’s broader strategy of leveraging U.S. manufacturing to capture market share in high‑margin specialty generics. The company routinely introduces 10–15 new products each year, and the 180‑day exclusivity period allows it to secure early market share before broader generic competition emerges. This approach supports the company’s goal of making rare‑disease products account for roughly 60 % of total net revenues by 2026.
President and CEO Nikhil Lalwani said the launch “reinforces our commitment to delivering high‑margin specialty generics while we accelerate our transformation into a leading rare‑disease company.” He added that the generics business “provides the cash flow needed to fund our rare‑disease pipeline and disciplined capital deployment.”
ANI’s Q4 2025 results illustrate the strength of this dual‑focus strategy. Net revenues rose 43.8 % year‑over‑year to $883.4 million, driven by a 28.2 % increase in the generics segment and an 87.6 % jump in the rare‑disease segment, particularly Cortrophin Gel. Adjusted non‑GAAP EBITDA reached $229.8 million, up 47.3 % YoY, and the company beat earnings expectations with a diluted EPS of $2.33 versus the $1.97 consensus. The company reaffirmed its 2026 guidance, projecting total net revenues between $1,055 million and $1,115 million.
The Pimozide market is currently dominated by the brand Orap, and the 180‑day exclusivity period protects ANI from competition until the end of that window. After the exclusivity expires, other generics manufacturers will be able to enter the market, potentially eroding the company’s early‑stage pricing power. Nonetheless, the launch adds a new revenue stream that, while small relative to the company’s overall top line, demonstrates ANI’s ability to generate incremental cash flow from its generics platform.
The launch of Pimozide tablets is a notable milestone for ANI’s generics business, reinforcing its strategy of leveraging U.S. manufacturing capabilities to capture market share in high‑margin specialty generics. While the projected sales volume is modest relative to the company’s overall revenue, the 180‑day exclusivity period provides a short‑term competitive advantage and supports the company’s cash‑generating foundation for future growth initiatives.
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