AbbVie Reaches Settlement with Generic Drugmakers Over Rinvoq, Securing U.S. Market Exclusivity Until April 2037

According to the SmartCom APP, AbbVie Inc. (ABBV.US) announced on Thursday that it had reached a settlement with all the generic drug companies involved in the lawsuit, resolving the litigation related to "plans by generic drug companies to launch generic versions of Rinvoq." Rinvoq is a key drug in AbbVie's immunotherapy product line.

Previously, these generic drug companies had submitted an "Abbreviated New Drug Application" (ANDA) to the U.S. Food and Drug Administration (FDA), seeking to launch a non-patented version (i.e., generic version) of this arthritis treatment drug.

AbbVie stated in a regulatory filing that, thanks to the settlement and licensing agreements reached, generic versions of Rinvoq tablets are not expected to enter the U.S. market until April 2037.

This pharmaceutical giant, headquartered in North Chicago, Illinois, has positioned Rinvoq and its "sister drug" Skyrizi as potential replacements for the blockbuster arthritis drug Humira, which lost its U.S. market exclusivity (i.e., patent protection expired, allowing legal entry of generics) in 2023.

In the first half of 2025, Rinvoq's net sales reached $2.7 billion, a year-on-year increase of approximately 53%; in contrast, during the same period, Humira's sales in the U.S. market declined by about 63% year-on-year.