The clock is ticking on Vanda Pharmaceuticals’ sleep disorder drug Hetlioz—and, Tuesday, it got louder.
A federal court in Delaware has not only rejected (PDF) Vanda’s claim of patent infringement against generic drug makers Teva Pharmaceuticals and Apotex, it has ruled that four of Vanda’s patent claims are invalid.
With generic competition looming, the prospects for Washington, D.C.-based Vanda are dim. Last year, with sales of $173.5 million, the pill accounted for 65% of the company’s revenue.
With news of the defeat, Vanda’s share price tumbled by 33% on Tuesday.
Vanda said it will appeal the decision, requesting a “stay of market entry” by the generics companies while the appeal is pending.
Hetlioz, which won FDA approval in 2014, remains the only therapy for non-24-hour sleep-wake disorder. The circadian rhythm ailment affects approximately 70% of people who are totally blind.
The patent decision does not relate to Hetlioz’s oral suspension formula and will not affect its status in Europe, the company said.
In 2019, the company’s bid for a label expansion to treat jet lag was met with a complete response letter from the FDA. Vanda’s efforts to receive a hearing to revisit the decision have gone for naught, and, earlier this year, the company filed suit against the agency.
The FDA and Vanda have had a difficult relationship. In 2020, a U.S. district court in Washington, D.C., sided with the regulator after the company challenged the agency’s partial clinical hold on its investigative gastroparesis treatment tradipitant.
The court ruled that the FDA could require Vanda to conduct animal studies to show that the drug wasn’t toxic.