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): October 4, 2018 (October 3, 2018)




(Exact name of Registrant as specified in its charter)




(State or other jurisdiction of incorporation)


001-34186   03-0491827


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.


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: October 4, 2018    



/s/ Timothy Williams


Timothy Williams


Senior Vice President, General Counsel and Secretary