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): February 26, 2016
INCYTE CORPORATION
(Exact name of registrant as specified in its charter)
Delaware |
|
0-27488 |
|
94-3136539 |
1801 Augustine Cut-Off |
|
|
Wilmington, DE |
|
19803 |
(Address of principal executive offices) |
|
(Zip Code) |
(302) 498-6700
(Registrants telephone number,
including area code)
N/A
(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 obligations of the registrant under any of the following provisions (see General Instruction A.2. below):
o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
Item 8.01 Other Events.
On February 26, 2016, Incyte Corporation (Incyte) received a Paragraph IV certification notice (the Notice Letter) regarding an Abbreviated New Drug Application (an ANDA) submitted to the U.S. Food and Drug Administration (the FDA) requesting approval to market a generic version of Jakafi® (ruxolitinib). The Notice Letter purports to challenge patents covering ruxolitinib phosphate and its use that expire in 2028. The Notice Letter does not challenge the ruxolitinib composition of matter patent, which expires on December 24, 2027.
SIGNATURE
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: February 29, 2016
|
INCYTE CORPORATION | |
|
| |
|
| |
|
By: |
/s/ Eric H. Siegel |
|
|
Eric H. Siegel |
|
|
Executive Vice President and |
|
|
General Counsel |