Item 8.01. Other Events.
In June 2021, Jazz Pharmaceuticals plc (the "Company") received notice from
Lupin Inc. ("Lupin"), that it has filed with the U.S. Food and Drug
Administration ("FDA") an Abbreviated New Drug Application ("ANDA"), for a
generic version of Xywav. The notice from Lupin included a "paragraph IV
certification" with respect to ten of the Company's patents listed in FDA's
Orange Book for Xywav on the date of the receipt of the notice. The asserted
patents relate generally to the composition and method of use of Xywav, and
methods of treatment when Xywav is administered concomitantly with certain other
medications. A paragraph IV certification is a certification by a generic
applicant that alleges that patents covering the branded product are invalid,
unenforceable, and/or will not be infringed by the manufacture, use or sale of
the generic product.
On July 28, 2021, the Company filed a patent infringement suit against Lupin in
the United States District Court for the District of New Jersey. The complaint
alleges that by filing its ANDA, Lupin has infringed ten of the Company's Orange
Book listed patents, seeking a permanent injunction to prevent Lupin from
introducing a generic version of Xywav that would infringe the Company's
patents. As a result of this lawsuit, the Company expects that a stay of
approval of up to 30 months will be imposed by FDA on Lupin's ANDA. As recently
recognized by FDA, Xywav also has Orphan Drug Exclusivity through July 21, 2027.
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