Short answer: Humira (adalimumab) is protected by a large, multi‑patent portfolio. Over time, many core protection lines have expired in major markets, and biosimilars are now on the market in several places, though some narrower patents (e.g., on specific uses, formulations, or manufacturing processes) can still affect certain activities in some jurisdictions.
A quick, high-level overview
- What is protected:
- Composition-of-matter patents covering the adalimumab antibody itself.
- Method-of-use patents covering treating diseases such as rheumatoid arthritis, Crohn’s disease, ulcerative colitis, psoriasis, etc.
- Formulation, dosage, and manufacturing/process patents.
- Potential regulatory/data protections (data exclusivity) in some markets.
- United States:
- The core composition patents and many key claims have expired or are near expiry, enabling biosimilar competition beginning around 2023–2024.
- Some later patents and/or formation/use claims and exclusivities may have slowed entry in certain cases, and there has been litigation around remaining claims.
- European Union:
- A mix of expired core patents and some later-filed or more narrow patents; biosimilars entered earlier (roughly around 2017–2019 in many markets) and competition has been strong.
- Other major markets (Canada, Japan, Australia, etc.):
- Generally similar pattern: core patents expired earlier in many places, with continued protection on narrower claims in some jurisdictions.
If you’re after specifics, tell me:
- Which country or region you care about (US, EU, UK, Canada, Japan, etc.)?
- Are you interested in current status, historic expiry timelines, or particular patent numbers?
- Do you want (a) a summary for patients/drug availability or (b) a more detailed patent-law perspective?
Note: I can’t give legal advice, but I can point you to resources and outline typical patent types and how to look up current status in patent databases (USPTO, EPO, Google Patents, etc.).