US Federal Circuit Pauses Teva, Apotex After Hetlioz Patent Win
Vanda’s Tasimelteon Molecule Patent Expired ‘Just Last Week’
Teva and Apotex must put their plans to launch generic versions of Vanda’s Hetlioz on ice after the originator was granted – for now – a small injunction against the ANDA sponsors.
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Generics Bulletin previews the most notable and anticipated events for August 2023.
Vanda is fighting FDA’s rejection of jet lag indication for Hetlioz as it faces generic competition for sleep-wake disorder treatment. Federal Circuit finds four Hetlioz patents invalid.
Vanda complaint against US FDA says generic label is not the same as Hetlioz and omission of braille lettering will increase medication errors. Company seeks recall of Teva’s product.