Jazz Pharmaceuticals plc false 0001232524 0001232524 2021-07-28 2021-07-28












Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

July 28, 2021

Date of Report (Date of earliest event reported)

July 28, 2021




(Exact name of registrant as specified in its charter)




Ireland   001-33500   98-1032470
(State or Other Jurisdiction
of Incorporation)
File No.)
  (IRS Employer
Identification No.)

Fifth Floor, Waterloo Exchange,

Waterloo Road, Dublin 4, Ireland D04 E5W7

(Address of principal executive offices, including zip code)


(Registrant’s telephone number, including area code)



Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:


Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)


Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)


Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))


Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered pursuant to Section 12(b) of the Act:


Title of each class





Name of each exchange

on which registered

Ordinary shares, nominal value $0.0001 per share   JAZZ   The Nasdaq Stock Market LLC

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter).

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐




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.


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.



/s/ Neena M. Patil

Name:   Neena M. Patil
Title:   Chief Legal Officer and SVP, Legal and Corporate Affairs

Date: July 28, 2021