SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
Pursuant to Section 13 or 15(d)
of the Securities Exchange Act of 1934
Date of Report (Date of earliest event reported)
July 28, 2021
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|Item 8.01.|| |
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.
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
|JAZZ PHARMACEUTICALS PUBLIC LIMITED COMPANY|
|Name:||Neena M. Patil|
|Title:||Chief Legal Officer and SVP, Legal and Corporate Affairs|
Date: July 28, 2021