Patent expiration date of guselkumab?

When does the main guselkumab patent expire?
The primary U.S. patent that protects guselkumab (Taltz®) ends on January 15, 2026. After that date, the drug’s exclusivity protection ends, opening the door for potential biosimilar entry. [1]

Which patents cover guselkumab’s key attributes?
The patents that cover the antibody sequence, its IL‑23‑binding properties, and the manufacturing process run until 2026. A secondary set of patents covering specific formulations and delivery methods expires in 2028. These staggered expirations mean that certain aspects of the drug remain protected even after the first expiry. [1]

Can biosimilars launch immediately after 2026?
Not immediately. Even after the primary patent lapses, regulatory approval requires that a biosimilar demonstrates comparable safety, efficacy, and manufacturing quality. The FDA’s biosimilar approval timeline typically takes 12–18 months once the application is filed. Thus, a biosimilar could appear as early as late 2027 or 2028, assuming all regulatory and commercial hurdles are cleared. [1]

What impact does the expiration have on pricing and market competition?
When the patents expire, the incumbent’s market exclusivity ends, allowing competitors to launch lower‑priced alternatives. Historically, psoriasis biologics have seen price reductions of 20–40 % when biosimilars enter the market. This trend is expected to continue for guselkumab once the biosimilar approvals materialize. [1]

Are there any legal challenges or patent extensions?
No current litigation has extended the guselkumab patents beyond 2026. The original patent holder has not pursued additional exclusivity through new patents or orphan‑drug status, so the expiration dates listed remain in force. [1]

How does guselkumab’s patent situation compare to other IL‑23 blockers?
Other IL‑23 inhibitors, such as risankizumab (Skyrizi®), have patent expirations set for 2030. Guselkumab’s earlier expiry could make it the first IL‑23 biologic to face generic competition, potentially shifting prescribing patterns toward cheaper alternatives. [1]

Sources
[1] DrugPatentWatch.com – Guselkumab (Taltz®) Patent Information. https://www.drugpatentwatch.com/patents/guselkumab/​