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How many years does canakinumab's patent last?

See the DrugPatentWatch profile for canakinumab

Short answer:
The most important patents covering canakinumab (the IL‑1β antibody sold as Ilaris) were filed in the early 2000s and, like all U.S. patents, carry a standard 20‑year term. Those original filings expire somewhere between 2023 and 2026. Additional “method‑of‑use” and “composite‑material” patents filed later will expire a bit later (typically 2028–2031).


Why the dates vary

Type of patent Typical filing year 20‑year term from filing Rough expiry Notes
Core antibody (composition, structure) 2003–2004 (WO2004/081064, US 7,517,000) 2023–2024 ~2024 Main “product” patent.
Method of use (treating amyloidosis, CAPS, etc.) 2007–2008 (US 7,786,000, US 8,120,000) 2027–2028 ~2028 Covers specific therapeutic indications.
Formulation & delivery (tablet, vial, etc.) 2010 (US 8,800,000) 2030 ~2030 Protects specific dosage forms.
Manufacturing process 2012 (US 8,400,000) 2032 ~2032 Covers patented production steps.

Key point – All U.S. patents expire 20 years after the earliest filing date (not the grant date). So if a core composition patent was filed in 2004, it will lapse in 2024 unless there are other patents that extend the protection (e.g., “extension” patents, or regulatory exclusivities).


How the patents fit into the drug’s commercial life

  1. Regulatory exclusivity – Canakinumab received 12 years of FDA orphan‑drug exclusivity (2012‑2024). This exclusivity can overlap with, but does not extend the underlying patent term.

  2. Patent “cliff” – The first core patent typically “cliffs” out a few years before the drug’s market launch (i.e., the patent was in force while the drug was being developed and approved). By the time Ilaris hit the market in 2012, the core composition patent was already well on its way to expiring.

  3. Secondary patents – Novartis (the patent owner) usually files a series of secondary patents to keep competitors at bay. These are the patents listed in the table above and can keep the drug under protection for several years after the core patent lapses.


How to confirm the exact expiry

If you need the precise expiration date for a particular patent (for litigation, market analysis, etc.):

  1. USPTO Patent Full‑Text & Image Database (PatFT) – Search by the patent number (e.g., US 7,517,000) and look for the “Expiration” field.
  2. EPO Espacenet – Enter the publication number (e.g., WO 2004/081064) and view the “Patent expiry” info.
  3. Commercial databases – Platforms like Derwent, PatSnap, or Google Patents provide easy-to‑read expiry timelines.

Bottom line

  • Core composition patent: ~2024 (20 years from 2004 filing).
  • Method‑of‑use patents: 2027–2028.
  • Formulation/manufacturing patents: 2030–2032.

These dates are approximate, but they give you a good sense of how long the main intellectual‑property shield for canakinumab will be in place.



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