0001193125-18-293314.txt : 20181004 0001193125-18-293314.hdr.sgml : 20181004 20181004163105 ACCESSION NUMBER: 0001193125-18-293314 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 1 CONFORMED PERIOD OF REPORT: 20181003 ITEM INFORMATION: Other Events FILED AS OF DATE: 20181004 DATE AS OF CHANGE: 20181004 FILER: COMPANY DATA: COMPANY CONFORMED NAME: Vanda Pharmaceuticals Inc. CENTRAL INDEX KEY: 0001347178 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 030491827 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-34186 FILM NUMBER: 181108192 BUSINESS ADDRESS: STREET 1: 2200 PENNSYLVANIA AVE NW STREET 2: SUITE 300E CITY: WASHINGTON STATE: DC ZIP: 20037 BUSINESS PHONE: 202-734-3400 MAIL ADDRESS: STREET 1: 2200 PENNSYLVANIA AVE NW STREET 2: SUITE 300E CITY: WASHINGTON STATE: DC ZIP: 20037 8-K 1 d625217d8k.htm 8-K 8-K

 

 

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 8-K

 

 

CURRENT REPORT

Pursuant to Section 13 or 15(d)

of the Securities Exchange Act of 1934

Date of Report (Date of earliest event reported): October 4, 2018 (October 3, 2018)

 

 

VANDA PHARMACEUTICALS INC.

(Exact name of Registrant as specified in its charter)

 

 

Delaware

(State or other jurisdiction of incorporation)

 

001-34186   03-0491827

(Commission

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:

 

☐

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))

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 October 3, 2018, the U.S. Food and Drug Administration publication, Approved Drug Products With Therapeutic Equivalence Evaluations, commonly known as the Orange Book, updated its listing for the Vanda Pharmaceuticals Inc. (Vanda) new chemical entity patent, number 5,856,529, for HETLIOZ® (the ‘529 Patent) to reflect the receipt of the full five-year extension of the expiration date under the Hatch-Waxman Act. Prior to receipt of the five-year Hatch-Waxman extension, the ‘529 Patent was set to expire in December 2018 following an interim one-year extension granted in 2017. With the five-year extension, the ‘529 Patent is now set to expire in December 2022 absent any other applicable patent term extensions. Including the ‘529 Patent, Vanda currently has a total of 8 patents covering HETLIOZ® listed in the Orange Book, the latest of which has an expiration date of February 2035.

SIGNATURES

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.

 

   

VANDA PHARMACEUTICALS INC.

Dated: October 4, 2018    

By:

  

/s/ Timothy Williams

    Name:  

Timothy Williams

    Title:  

Senior Vice President, General Counsel and Secretary