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Humira patent cliff?

See the DrugPatentWatch profile for Humira

Short answer: Humira (adalimumab) has faced a patent cliff in major markets, but the picture is nuanced because of a large patent thicket and settlements.

What happened (high-level)
- US: The key composition-of-matter patent for adalimumab ultimately expired around 2023, opening the door for biosimilars to compete. However, a bundle of follow-on patents and regulatory exclusivities (and settlements with biosimilar makers) delayed full, broad entry in some cases. By 2023–2024, biosimilars began to enter the US market in earnest, bringing meaningful price competition.
- EU/other markets: Europe saw earlier and more extensive biosimilar competition (many Humira biosimilars were launched there starting around 2018–2019). The US‑style “cliff” played out later there, with ongoing competition and price pressure through the mid‑2020s.

Key takeaways
- The “patent cliff” in the US is largely realized for the molecule’s core patent, but Humira still faces ongoing legal and regulatory protections in some jurisdictions and for some indications or formulations.
- Biosimilar competition has been strong in Europe for several years and has grown in the US since 2023–2024.
- Price pressure from biosimilars remains a major factor for Humira’s market dynamics, but AbbVie still maintains a large sales presence due to brand recognition, patient support, and therapeutic options.

If you’d like, I can tailor this to a specific market (US, EU, or another country) and give a concise timeline with the key patent and biosimilar entry dates.



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