Stelara patent expiry?

Stelara (ustekinumab) – Patent Landscape Overview

(All dates are approximate and reflect the most recent publicly‑available U.S. and international patent filings as of 2026. Actual commercial exclusivity can be longer if the drug is still covered by product‑exclusivity, patent‑term extensions, or other legal mechanisms.)

Why the “expiry” date varies so much

1. Multiple layers of protection – The original antibody composition patents (covering the genetic sequence and the antibody itself) have long expired, but newer patents cover:

   • Specific therapeutic indications (psoriasis, Crohn’s disease, ulcerative colitis, etc.).
   • Formulations and delivery devices (pre‑filled syringes, injection pens).
   • Manufacturing processes (glycosylation patterns, cell‑line development).

2. Patent‑term extensions (PTEs) – Under U.S. law, a drug can receive up to 5 years of extension if the FDA’s approval process took longer than the statutory 6 years. This can push the effective expiry later than the filing‑to‑grant window.

3. Exclusivity periods – Even after a patent expires, the drug can enjoy product exclusivity (e.g., 5‑year biologic exclusivity in the U.S.) that blocks generic entry. The expiry of exclusivity often aligns closely with the last of the active use patents.

4. Regional differences – The EU, Canada, and Japan each have their own rules for granting and terminating exclusivity. In the EU, for example, a biologic enjoys a 10‑year exclusivity period from the date of first approval, but can also be protected by use patents that expire earlier or later.

What this means for patients & payers

Bottom line

• Stelara’s core antibody patents are long expired (2018‑2020).
• The remaining key protection is the use patents, which expire between 2025 and 2027, depending on the country.
• Exclusivity periods and possible patent‑term extensions may push the effective market exclusivity to about 2026‑2027 in the U.S., 2028 in the EU, and 2028 in Canada.
• Biosimilars are expected to enter the market around 2028‑2029 once the last of the patents expires and regulatory approvals are secured.

Tip: If you’re a clinician, pharmacist, or insurer, keep an eye on the U.S. Patent and Trademark Office (USPTO) and European Medicines Agency (EMA) databases. They publish “Patent Status” reports that update the expiry of each active claim. For the most accurate, real‑time status, the FDA’s “Orange Book” and the EMA’s “Biosimilar Review” sections are the best references.