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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): September 11, 2025
ABBVIE
INC.
(Exact name of registrant as specified in its charter)
Delaware |
|
001-35565 |
|
32-0375147 |
(State or other jurisdiction of incorporation) |
|
(Commission File Number) |
|
(IRS Employer
Identification No.) |
1
North Waukegan Road
North
Chicago, Illinois 60064-6400
(Address of principal executive offices)(Zip Code)
Registrant’s
telephone number, including area code: (847) 932-7900
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)) |
Securities registered pursuant to Section 12(b) of the Act:
Title
of each class |
|
Trading
Symbol(s) |
|
Name
of each exchange on which registered |
Common
Stock, $0.01 Par Value |
|
ABBV |
|
New
York Stock Exchange |
|
|
|
|
NYSE Texas |
0.750%
Senior Notes due 2027 |
|
ABBV27 |
|
New
York Stock Exchange |
2.125%
Senior Notes due 2028 |
|
ABBV28 |
|
New
York Stock Exchange |
2.625%
Senior Notes due 2028 |
|
ABBV28B |
|
New
York Stock Exchange |
2.125%
Senior Notes due 2029 |
|
ABBV29 |
|
New
York Stock Exchange |
1.250%
Senior Notes due 2031 |
|
ABBV31 |
|
New
York Stock Exchange |
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 7.01 Regulation FD Disclosure
On September 11, 2025, AbbVie announced that it has settled litigation
with all generic manufacturers that filed abbreviated new drug applications with the U.S. Food and Drug Administration for generic
versions of upadacitinib tablets, which AbbVie markets as RINVOQ.
Given the settlement and license agreements, which are subject to standard
acceleration provisions, assuming pediatric exclusivity is granted, no generic entry for any upadacitinib tablets is expected prior to
April 2037 in the United States.
Some statements in this filing are, or may be considered, forward-looking
statements for purposes of the Private Securities Litigation Reform Act of 1995. The words "believe," "expect," "anticipate,"
"project" and similar expressions and uses of future or conditional verbs, generally identify forward-looking statements. AbbVie
cautions that these forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially
from those expressed or implied in the forward-looking statements. Such risks and uncertainties include, but are not limited to, challenges
to intellectual property, adverse litigation or government action, changes to laws and regulations applicable to our industry, and other
uncertainties and risks associated with global business operations. Additional information about the economic, competitive, governmental,
technological and other factors that may affect AbbVie's operations is set forth in Item 1A, "Risk Factors," of AbbVie's 2024
Annual Report on Form 10-K, which has been filed with the Securities and Exchange Commission, as updated by its Quarterly Reports
on Form 10-Q and in other documents that AbbVie subsequently files with the Securities and Exchange Commission that update, supplement
or supersede such information. AbbVie undertakes no obligation, and specifically declines, to release publicly any revisions to forward-looking
statements as a result of subsequent events or developments, except as required by law.
The information in this Item 7.01, including the exhibit referenced
herein and attached hereto, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of
1934 (the “Exchange Act”), nor shall it be deemed incorporated by reference in any Company filing under the Securities Act
of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such filing.
Item 9.01 Financial Statements and Exhibits
(d) Exhibits
Exhibit No. |
|
Exhibit |
|
|
|
104 |
|
Cover Page Interactive Data File (embedded within the Inline XBRL document) |
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.
|
|
|
ABBVIE INC. |
|
|
|
|
Date: |
September 11, 2025 |
By: |
/s/ Perry C. Siatis |
|
|
|
Perry C. Siatis |
|
|
|
Executive Vice President, General Counsel and Secretary |