Vanda Pharmaceuticals is actively pursuing new markets and indications for Hetlioz to offset declining sales attributed to increased generic competition in the United States. The company's efforts include seeking FDA approval for jet lag disorder and insomnia, as well as defending its intellectual property through ongoing litigation.
Hetlioz Sales Impacted by Generics
For the first nine months of 2024, Vanda reported a 28% decrease in net product sales for Hetlioz. According to Vanda, this decline is a direct consequence of generic versions of the drug entering the market. Despite this overall decrease, Q3 sales of Hetlioz showed a slight increase, reaching $17.9 million compared to $17.5 million in the same quarter of the previous year.
Pursuing New Indications and Markets
To counter the impact of generic competition, Vanda is focusing on expanding the approved uses of Hetlioz. "We are committed to growing our revenue from our existing products and continuing to diversify our sources of revenue through indication expansion and new product development," stated Mihael H. Polymeropoulos, MD, Vanda's President, CEO, and Chairman of the Board.
The company has initiated a Hetlioz LQ program targeting pediatric insomnia, a condition for which there are currently no approved treatments. Studies estimate that 20-40% of children experience significant sleep problems, highlighting the potential need for effective interventions.
Vanda is also actively seeking FDA approval for Hetlioz in the treatment of jet lag disorder and insomnia. The company is challenging the FDA's rejection of its supplemental New Drug Application (sNDA) for jet lag in the US Court of Appeals for the DC Circuit and has requested a hearing with the FDA regarding the approvability of the insomnia sNDA.
Patent Litigation and European Expansion
Vanda is engaged in litigation to protect its Hetlioz Patent No. 11,285,129 against generic manufacturers. A jury trial is scheduled for the first quarter of 2026 in the US District Court for the District of Delaware.
In addition to its efforts in the United States, Vanda anticipates a decision from the European Medicines Agency (EMA) in the first quarter of 2025 regarding its Marketing Authorization Application for Hetlioz and Hetlioz LQ for Smith-Magenis Syndrome.
