AbbVie settles RINVOQ generic cases, delays rivals

AbbVie Inc. reported that it has settled litigation with all generic drug manufacturers that filed abbreviated new drug applications in the United States for generic versions of its upadacitinib tablets, marketed as RINVOQ.

Rhea-AI Filing Summary

AbbVie Inc. reported that it has settled litigation with all generic drug manufacturers that filed abbreviated new drug applications in the United States for generic versions of its upadacitinib tablets, marketed as RINVOQ. Based on these settlement and license agreements, and assuming pediatric exclusivity is granted, AbbVie does not expect any generic upadacitinib tablet products to enter the U.S. market before April 2037, subject to standard acceleration provisions in the agreements.

The company also reiterated that these expectations are forward-looking and could be affected by factors such as intellectual property challenges, litigation outcomes, regulatory changes, and broader business risks described in its prior annual and quarterly reports.

Positive

• AbbVie settles all U.S. RINVOQ tablet generic litigation, with settlement and license agreements indicating no generic upadacitinib tablet entry is expected before April 2037, assuming pediatric exclusivity is granted.
• U.S. market exclusivity for RINVOQ tablets is effectively extended under these agreements, which may support longer-term revenue from the branded upadacitinib tablet franchise, subject to standard acceleration provisions and other risks.

Negative

• None.

Insights

Pharmaceutical IP and lifecycle strategy analyst

Settling RINVOQ generic cases aims to keep U.S. tablets generic‑free until April 2037.

AbbVie has reached settlement and license agreements with all generic manufacturers that sought U.S. approval for generic upadacitinib tablets, sold as RINVOQ. The agreements indicate that, assuming pediatric exclusivity is granted, no generic tablet entry is expected in the United States before April 2037, with standard acceleration provisions governing potential changes.

Delaying generic competition for a branded autoimmune therapy can help preserve pricing power and revenue durability for the tablet formulation during this period. The disclosure underscores that this expectation is forward‑looking and depends on intellectual property strength, litigation dynamics, regulatory decisions, and broader risk factors previously outlined in AbbVie’s 2024 Form 10‑K and subsequent Form 10‑Q filings.

Investors can treat April 2037 as the current reference point for potential U.S. generic tablet entry for upadacitinib under these settlements, while recognizing that standard acceleration provisions and regulatory developments may affect timing.

8-K Event Classification

Item 7.01 — Regulation FD Disclosure

1 item

Item 7.01 Regulation FD Disclosure Disclosure

Material non-public information disclosed under Regulation Fair Disclosure, often investor presentations or guidance.

FAQ

What did AbbVie (ABBV) announce regarding RINVOQ generics?

AbbVie announced that it has settled litigation with all generic manufacturers that filed abbreviated new drug applications in the U.S. for generic versions of upadacitinib tablets, which it markets as RINVOQ.

When are generic RINVOQ (upadacitinib) tablets expected to enter the U.S. market?

Based on the settlement and license agreements, and assuming pediatric exclusivity is granted, AbbVie does not expect any generic upadacitinib tablets to enter the U.S. market before April 2037, subject to standard acceleration provisions.

Which product is covered by AbbVie’s new settlement with generic manufacturers?

The settlement covers upadacitinib tablets, which AbbVie markets under the brand name RINVOQ in the United States.

Does AbbVie’s statement about RINVOQ generics involve forward-looking risks?

Yes. AbbVie notes that the expectations about no generic entry before April 2037 are forward-looking statements subject to risks such as intellectual property challenges, litigation outcomes, regulatory changes, and other factors described in its 2024 Form 10-K and subsequent Form 10-Q filings.

Is the RINVOQ generic entry timing dependent on pediatric exclusivity for AbbVie (ABBV)?

AbbVie’s expectation that no generic upadacitinib tablets will enter the U.S. market before April 2037 is stated to apply assuming pediatric exclusivity is granted.

What kind of SEC filing did AbbVie use to disclose the RINVOQ settlement?

AbbVie disclosed the RINVOQ generic settlement and related expectations in an Item 7.01 Regulation FD Disclosure within a Form 8-K.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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Accepted by SEC EDGAR 09/11/2025 - 07:30 AM Learn about SEC filing dates

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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