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): October 4, 2018 (October 3, 2018)
VANDA PHARMACEUTICALS INC.
(Exact name of Registrant as specified in its charter)
(State or other jurisdiction of incorporation)
2200 Pennsylvania Avenue NW
Washington, DC 20037
(Address of principal executive offices and zip code)
Registrants telephone number, including area code: (202) 734-3400
(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.|| |
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.
VANDA PHARMACEUTICALS INC.
|Dated: October 4, 2018||
Senior Vice President, General Counsel and Secretary