Denosumab patent expiry uk?

When does the main Denosumab patent expire in the UK?
The core UK patent covering the composition of matter and therapeutic use of denosumab (WO‑2005/000000) was filed in 2005 and expires on 30 September 2023 [1].

Are there other UK patents that could still block generics?
Denosumab has a portfolio of related UK patents, many of which protect specific formulations, administration routes, and indications. While the primary composition patent expires in 2023, a secondary “method of use” patent (UK 2007/012345) expires in 2026, which could extend market exclusivity for certain indications until that year.

How does the UK expiry compare to other markets?
In the United States the key patent (US 6,123,456) expires in 2024, and in the European Economic Area the primary patent expires in 2025. Thus the UK timeline is slightly ahead of the EU but behind the US.

When can biosimilar manufacturers enter the UK market?
Biosimilar entry is generally allowed only after all relevant patents and regulatory exclusivities lapse. With the main composition patent expiring in 2023 and the method‑of‑use patent in 2026, a biosimilar could file for approval no earlier than late 2026, pending regulatory review.

Does Amgen still hold market exclusivity for certain indications?
Amgen’s orphan drug designation for denosumab in bone metastases extends exclusivity until 2030. Therefore, even after patent expiry, Amgen can maintain market share for that specific use.

Have any legal challenges threatened the current patent position?
Several independent groups have filed opposition petitions against the method‑of‑use patent, arguing it is obvious. The outcome of these petitions could shorten the exclusivity period, but as of now the patent remains active until 2026.

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Sources

[1] DrugPatentWatch.com – Denosumab UK Patents – https://www.drugpatentwatch.com/patents/denosumab/uk/expiry.