Company: ABBV
Filing Date: 2025-11-04
Form Type: 10-Q
Source: 0001551152-25-000049
Chunk: 2

Company: AbbVie Inc.
Filing Date: 2025-11-04
Form: 10-Q
Item: Part I, Item 2
Chunk 2
---
 issued on May 12, 2025, directs the Secretary of Health and Human Services (HHS) to pursue most-favored-nation (MFN) pricing, defined as the lowest price in any Organization for Economic Co-operation and Development country with a gross domestic product per capita of at least 60% of that of the United States. The order directs HHS to implement policies mandating MFN pricing along with other regulatory actions if substantial progress toward voluntary compliance is not achieved. AbbVie continues to evaluate the potential impact of this executive order, and any new or additional legislation, regulations or executive orders related to pharmaceutical pricing may increase uncertainties and associated risks and could adversely impact AbbVie’s business and results of operations. 

On July 4, 2025, the United States government signed into law the One Big Beautiful Bill Act of 2025 (2025 Act). Included within the 2025 Act are provisions that permanently extend certain expiring provisions of the 2017 Tax Cuts and Jobs Act, modify the international tax framework to reduce the tax rate on certain foreign earned income, restore the tax treatment of expensing for domestic research and development costs and bonus depreciation, and allow for full expensing of qualified production property. In addition, the legislation contains multiple effective dates and transition elections, with certain provisions effective in 2025 and others implemented through 2027. The 2025 Act also includes certain new health care provisions related to the orphan drug exclusion of the Inflation Reduction Act of 2022, and Medicaid, which have various effective dates. The company expects the new legislation to have a favorable impact on cash tax payments in the current year. The company will continue to assess the impact of the 2025 Act as further information is made available.

U.S. Capital Investment

In September 2025, AbbVie announced the start of construction of a new active pharmaceutical ingredient facility in Illinois and an expansion of biologics manufacturing and research and development capacity in Massachusetts. These projects are part of AbbVie's previously announced plan to increase capital investment in the U.S. to broadly support innovation and expand critical manufacturing capabilities and capacity.

Intellectual Property Protection and Regulatory Exclusivity

On September 11, 2025, AbbVie announced the settlement of 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