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Vanda provides update to Hetlioz ANDA litigation appeal

The United States Court of Appeals for the Federal Circuit has granted a motion to temporarily enjoin the generic launch by Teva and Apotex of Hetlioz.

On Dec. 14, 2022, Vanda appealed the Dec. 13 decision of the United States District Court for the District of Delaware in the Hetlioz ANDA litigation to the United States Court of Appeals for the Federal Circuit and requested an injunction prohibiting market entry by Teva and Apotex while the appeal is pending.

The court on Dec. 16, 2022, granted a temporary injunction to prohibit market entry by Teva and Aptex until at least Jan. 6, 2023, while the Court considers Vanda's pending motion for an injunction that would extend until the Court decides the appeal.

[Read more: Challenges continue, but generics companies see a bright future with biosimilars]

Hetlioz is the first and only medication that has been proven to treat people with non-24 and nighttime sleep disturbances in SMS.

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