Humira (adalimumab) – key patent expirations
| Patent (U.S.) | Key Claims (what it covers) | Expiration Date | Notes |
|---------------|-----------------------------|-----------------|-------|
| US 7,158,300 | “Human monoclonal antibody against TNF‑α” – the core adalimumab molecule | August 16 2014 | This was the earliest patent for the antibody itself. It has already expired. |
| US 7,605,000 | “Method of treating autoimmune disease with adalimumab” – therapeutic uses in rheumatoid arthritis, Crohn’s disease, etc. | November 28 2026 | The last of the “product‑use” patents that still shield Humira from generic entry in the U.S. |
| US 8,317,021 | “Adalimumab formulations and methods of delivery” – specific drug products and dosage forms | December 25 2028 | Covers certain formulations that can still be patented. |
| US 9,141,589 | “Adalimumab with specific glycosylation patterns” – biosimilar‑related claims | February 2 2034 | This is a “beyond‑the‑patent” claim that protects certain manufacturing details. |
What does this mean?
1. First U.S. patents expired – The original 1994‑1996 patents that covered the antibody itself are long gone (2014).
2. Last “use” patent expires in 2026 – Until then, the U.S. Federal Trade Commission (FTC) and the FDA consider Humira protected against generic competition.
3. Additional claims still protect certain formulations – Even after 2026, some of the more specific claims (formulations, manufacturing processes, etc.) keep parts of the product under patent until 2028‑2034.
What about generics/biosimilars?
* Amjevita® (by Amgen) – First U.S.‑approved biosimilar to Humira, cleared by the FDA in 2019 and launched in 2021.
* Other biosimilars – Several other biosimilars (by Samsung Biologics, Pfizer, etc.) have received FDA approval or are in late‑stage clinical trials.
* Generic (non‑biosimilar) entry – Because many of the original patents were invalidated or found not to cover the actual commercial product, Humira has faced earlier generic entry than a typical biologic would. However, the “use” and formulation patents still provide a shield until 2028‑2034, depending on the claim.
International picture
| Region | Expiry of main adalimumab patents | Notes |
|--------|----------------------------------|-------|
| EU | 2028 | The European Medicines Agency (EMA) listed a number of patents that expire in 2028. |
| Canada | 2027 | The Canadian Intellectual Property Office (CIPO) lists the same core patents, expiring in 2027. |
| Australia | 2028 | Patents on adalimumab and its uses expire in 2028. |
Bottom line
- The core adalimumab antibody patents have long since expired (2014).
- The most important “use” patents that protect Humira in the U.S. will expire on November 28 2026.
- Formulation‑ and process‑related patents can extend protection until 2028–2034.
- Biosimilar competitors have already entered the U.S. market (Amjevita, etc.) but the original product remains under patent protection until the dates above.
If you’re interested in a specific country or a particular claim set, let me know and I can dig deeper!