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Vanda Loses US Trade Secrets Battle Over Fanapt And Hetlioz Generics

 
• 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 said.

trade secrets
The federal court said the dissolution specifications adopted by generics firms were not developed by Vanda. • Source: Shutterstock
Key Takeaways
  • A federal court said the FDA did not improperly disclose trade secrets about Vanda’s Fanapt and Hetlioz to generics manufacturers.
  • Vanda claimed dissolution specifications, as well as impurities testing and micronization information, were given to generics manufacturers during ANDA reviews.
  • The court determined that Vanda did not develop the specifications at issue.

A federal court ruled in favor of the government after

Vanda’s May 2023 complaint focused on the proposed “dissolution specifications,” indicating the amount of the label-listed active ingredient that must dissolve by a specified point after administration for the drug to be safe and

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