Serial litigator Vanda Pharmaceuticals appears to have exhausted all options in its legal battle against Hetlioz (tasimelteon) abbreviated new drug application sponsors Teva and Apotex, after the US Supreme Court denied the originator’s petition for a writ of certiorari review of a decisive patent-litigation loss for its landmark sleep disorder drug.
Vanda Comes Up Empty Handed As US Supreme Court Denies Hetlioz Appeal
ANDA Sponsors Teva, Apotex, Already Launched At Risk Following Earlier Win
Vanda looks likely to have to face up to unimpeded US generic competition to its core Hetlioz brand, after a further denial in its litigation against ANDA sponsors Teva and Apotex.

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Teva should not be able to overturn European fines imposed over a historical “pay-for-delay” arrangement covering Cephalon’s Provigil (modafinil), an advocate general of the CJEU has recommended.
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Generics Bulletin previews the most noteworthy and anticipated events for April 2025.