AbbVie Settles Litigation with Generic Manufacturers, Delays Generic RINVOQ Entry Until 2037
AbbVie Inc. has settled litigation with generic manufacturers regarding its upadacitinib tablets, RINVOQ, delaying the entry of generic versions into the U.S. market until April 2037, assuming pediatric exclusivity is granted. The settlement includes license agreements with standard acceleration provisions, aimed at protecting AbbVie's proprietary formulations and extending market exclusivity.
AbbVie Inc. announced on September 11, 2025, that it has reached a settlement in litigation with all generic manufacturers that filed abbreviated new drug applications with the U.S. Food and Drug Administration for generic versions of its upadacitinib tablets, marketed as RINVOQ. The settlement includes license agreements subject to standard acceleration provisions. Assuming pediatric exclusivity is granted, no generic versions of upadacitinib tablets are anticipated to enter the U.S. market before April 2037. This development follows efforts to protect AbbVie’s proprietary formulations and extend market exclusivity for its product. Disclaimer: This news brief was created by Public Technologies (PUBT) using generative artificial intelligence. While PUBT strives to provide accurate and timely information, this AI-generated content is for informational purposes only and should not be interpreted as financial, investment, or legal advice. AbbVie Inc. published the original content used to generate this news brief via EDGAR, the Electronic Data Gathering, Analysis, and Retrieval system operated by the U.S. Securities and Exchange Commission (Ref. ID: 0001104659-25-089245), on September 11, 2025, and is solely responsible for the information contained therein. © Copyright 2025 - Public Technologies (PUBT) Original Document: here
