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Vanda Loses US Trade Secrets Battle On Fanapt And Hetlioz ANDA Products

Court In D.C. Finds NDA Dissolution Specifications Not Developed By Vanda

 
• By Dean Rudge

“While Vanda developed the brand-name drugs, the trade secret and confidential and proprietary information claimed to have been taken by the government was, in fact, proposed and recommended to Vanda by the FDA,” a US federal court found as it granted summary judgment to the US government.

trade secrets
• Source: Shutterstock

The US government was favored by a federal court in Washington D.C., after being sued by Vanda Pharmaceuticals for allegedly improperly disclosing the originator’s trade secrets and confidential commercial and proprietary information to generics manufacturers seeking approvals for versions of Vanda’s Fanapt (iloperidone) and Hetlioz (tasimelteon) brands.

At the crux of Vanda’s May 2023 complaint against the US government were the proposed “dissolution specifications,” indicating how much of the label-listed active ingredient must dissolve by a specified point after administration for the drug to

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