Biosimilar Pathway
Humira (adalimumab) is a biologic, not a small-molecule drug. Biologics are not listed in the FDA Orange Book and do not face conventional “generic” competition. Instead, follow-on competitors called biosimilars can be approved through the FDA’s BPCIA pathway, typically after the reference product’s 12-year exclusivity period and the resolution of any patent litigation.
For the current biosimilar approvals and exclusivity status of Humira, see the authoritative FDA Purple Book listing for adalimumab.
Related Drug Patent Expirations
44 patents · earliest expires 2027 · Pharmacyclics LLC
45 patents · earliest expires 2031 · AbbVie Inc.
0 patents · AbbVie Inc.
0 patents · Genentech Inc.
9 patents · earliest expires 2033 · Gilead Sciences Inc.
0 patents · Novartis AG
Humira is one of the data points covered by this site’s U.S. pharmaceutical patent expirations dataset. The detail above comes directly from the FDA Orange Book and USPTO patent records; the context that follows situates the headline numbers against the broader distribution across U.S. brand-name drugs.
Every number on this page links back to the FDA Orange Book and USPTO patent records; the methodology page describes the inputs, refresh cadence, and known limitations of the underlying data product.
Practical use of this page is in combination with the comparison and ranking pages elsewhere on the site, which surface the same data for Humira’s peers within U.S. brand-name drugs. A single-entity reading without peer context can be misleading when an entity is an outlier on one axis but typical on another.