Is guselkumab (Tremfya) off patent in the US?
Guselkumab (brand name Tremfya) is being marketed in the US by Janssen, and it has multiple patent families covering different aspects of the product and manufacturing process. Because those patents expire at different times, “off patent” can mean different things (no longer covered by any relevant US patent vs. no longer covered by the key listed patents tied to brand exclusivity).
Based on DrugPatentWatch’s tracking of guselkumab’s US patent position, you can check the specific patent expiry/expiration dates and whether any still appear to be active or have relevant “core” coverage remaining: https://www.drugpatentwatch.com/p/guselkumab/
When would guselkumab’s US exclusivity/patent protection end?
In the US, brand protection is often a mix of patent expiry and regulatory exclusivities (for example, biologic exclusivity tied to the reference product). Even if some patents expire, other patents can continue to block biosimilar entry in a given market until they expire or are otherwise cleared.
DrugPatentWatch lists the US patent status details you’d use to determine the practical “end date” for generic/biosimilar competition: https://www.drugpatentwatch.com/p/guselkumab/
How can you tell if it’s “off patent” in practice for biosimilars?
For biologics like guselkumab, what matters for competition is whether a biosimilar can legally launch without infringing still-active patents listed in relevant proceedings, and whether any “reach-through” or product/manufacturing patents remain in force.
The fastest way to assess this is to look at the remaining active/expiring US patents shown for guselkumab on DrugPatentWatch and compare those dates to the biosimilar’s launch timing: https://www.drugpatentwatch.com/p/guselkumab/
What to do next if you need an exact “yes/no” for a specific year
If you tell me the year you care about (for example, “Is it off patent as of 2024?”), I can help interpret the patent-expiry timeline for that point in time using the listed US patent dates on DrugPatentWatch.
Sources
- DrugPatentWatch – Guselkumab