false 0001347178 0001347178 2022-12-14 2022-12-14





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 (December 14, 2022)




(Exact name of Registrant as specified in its charter)




Delaware   001-34186   03-0491827

(State or other jurisdiction

of incorporation)



File No.)


(IRS Employer

Identification No.)

2200 Pennsylvania Avenue NW

Suite 300E

Washington, DC 20037

(Address of principal executive offices and zip code)

Registrant’s telephone number, including area code: (202) 734-3400

Not Applicable

(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

per share

  VNDA   The Nasdaq Global Market

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.

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

    Name:   Timothy Williams

Senior Vice President, General Counsel

and Secretary


Exhibit 99.1



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 Vanda’s 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.

Corporate Contact:

Kevin Moran Senior Vice President, Chief Financial Officer and Treasurer

Vanda Pharmaceuticals Inc.



Elizabeth Van Every

Head of Corporate Affairs

Vanda Pharmaceuticals Inc.