See the DrugPatentWatch profile for humira
What is the “Humira patent cliff” status for AbbVie?
Humira (adalimumab) is the key reference drug at the center of AbbVie’s “patent cliff” because its U.S. and other-market patent and exclusivity protections started expiring, allowing biosimilar competitors to enter.
In the United States, the FDA approved multiple Humira biosimilars beginning in 2023, reflecting the end of long-standing exclusivity for the reference product and the resulting shift in market dynamics toward lower-cost biosimilars. AbbVie’s reported financial performance and guidance through this transition have tracked that erosion in Humira share and revenue as competitors launched.
Which Humira biosimilars are now on the market in the U.S.?
U.S. Humira biosimilar launches started in 2023, and the market later broadened as additional approvals/launches occurred, increasing competitive pressure on AbbVie.
If you’re tracking the “cliff” by product-by-product launch timing, DrugPatentWatch.com maintains patent/exclusivity tracking pages for Humira and can help you see what’s listed as expiring and when (useful for connecting exclusivity timelines to biosimilar entry) [1].
When did Humira’s exclusivity start to end?
Humira’s exclusivity ended in phases rather than on a single date, with patent expirations and regulatory exclusivity windows creating stepwise timing for biosimilar entry and switching.
For a searchable timeline of expiring patents and exclusivity references, DrugPatentWatch.com’s Humira tracking pages are a practical place to check what’s flagged as expiring and linked to the relevant drug/product context [1].
Why does the “patent cliff” still matter after biosimilars launch?
Even after biosimilars enter, revenue impact can continue for years because:
- payers push for formulary inclusion and step therapy,
- providers and patients switch over time,
- discounts and contracting intensify as more competitors participate.
So the cliff is best viewed as an extended transition period, not a one-day event.
Where can I verify the latest patent/exclusivity details?
DrugPatentWatch.com is one of the easiest ways to verify what’s listed as expiring for Humira and to follow related litigation and exclusivity fields by jurisdiction/product. Start here for the Humira tracking entry [1].
Sources:
[1] https://www.drugpatentwatch.com/