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): December 16, 2022 (
(Exact name of Registrant as specified in its charter)
(State or other jurisdiction
(Address of principal executive offices and zip code)
Registrant’s telephone number, including area code:
(Former Name or Former Address, if Changed Since Last Report)
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 (see General Instruction A.2. below):
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
Common Stock, par value $0.001
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.|| |
On December 16, 2022, Vanda Pharmaceuticals Inc. (the “Company”) issued a press release providing an update on its appeal of the recent ruling of the United States District Court for the District of Delaware in the Company’s patent litigation involving its product HETLIOZ®.
The full text of the press release is attached as Exhibit 99.1 to this Current Report on Form 8-K and is incorporated by reference herein.
|Item 9.01.|| |
Financial Statements and Exhibits.
|99.1||Press release of Vanda Pharmaceuticals Inc. dated December 16, 2022.|
|104||Cover Page Interactive Data File (embedded within the Inline XBRL document).|
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.
|Dated: December 16, 2022||VANDA PHARMACEUTICALS INC.|
/s/ Timothy Williams
Senior Vice President, General Counsel
Vanda Pharmaceuticals Provides an Update to HETLIOZ® ANDA Litigation Appeal: Federal Circuit grants motion to temporarily enjoin generic launch
WASHINGTON, December 16, 2022 /PRNewswire/ Vanda Pharmaceuticals Inc. (Vanda) (Nasdaq: VNDA) today provided an update on its appeal of the recent HETLIOZ® ANDA litigation ruling.
On December 14, 2022, Vanda appealed the December 13th decision of the United States District Court for the District of Delaware in the HETLIOZ® ANDA litigation to the United States Court of Appeals for the Federal Circuit and requested an injunction prohibiting market entry by Teva Pharmaceuticals USA, Inc. (Teva) and Apotex Inc. (Apotex) while the appeal is pending. Today, the Court granted a temporary injunction to prohibit market entry by Teva and Apotex until at least January 6, 2023 while the Court considers Vandas pending motion for an injunction that would extend until the Court decides the appeal.
About Vanda Pharmaceuticals Inc.
Vanda is a leading global biopharmaceutical company focused on the development and commercialization of innovative therapies to address high unmet medical needs and improve the lives of patients. For more on Vanda Pharmaceuticals Inc., please visit www.vandapharma.com and follow us on Twitter @vandapharma.
For full U.S. Prescribing Information for HETLIOZ® and HETLIOZ LQ®, including indication and Important Safety Information, visit www.hetlioz.com.
Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer
Vanda Pharmaceuticals Inc.
Elizabeth Van Every
Head of Corporate Affairs
Vanda Pharmaceuticals Inc.