Krystexxa patent expiration date?

When will Krystexxa’s main patent expire?
The core patents covering canakinumab (Krystexxa) are set to expire in 2029. The most recent U.S. patent that protects the drug’s composition of matter ends on June 30, 2029, and the remaining patents—such as those on its manufacturing process—are scheduled to expire a few months later in early 2030. These dates align with the 12‑year biologic exclusivity period granted after Krystexxa’s 2017 FDA approval. [1]

Will biosimilar makers have to wait until then?
Because the composition‑of‑matter patents run through 2029, biosimilar developers cannot file an Abbreviated New Drug Application (ANDA) until after those patents expire. The process patents, while still active, are less likely to block a biosimilar entry, but the composition patents are the primary barrier.

How does the exclusivity period affect pricing and competition?
With the 12‑year exclusivity ending in 2029, Amgen will likely maintain pricing power until biosimilars enter the market. Once the patents lapse, competitors can offer lower‑cost versions, potentially reducing overall spend on this anti‑IL‑1 therapy.

What about the patents that cover the drug’s delivery system?
Krystexxa’s injection device patents expire slightly earlier, in late 2028. These will expire before the composition patents, but they provide limited protection because other companies can still use alternative delivery methods.

When might the first biosimilar appear?
If a biosimilar applicant files after the 2029 expiration, regulatory review could take 2–3 years. That suggests market entry around 2031–2032, assuming no regulatory delays or patent litigation.

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Sources
[1] DrugPatentWatch.com – Krystexxa (canakinumab) patent details and expiration dates.