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See the DrugPatentWatch profile for Stelara
Stelara (ustekinumab) is protected by multiple patent families in the US and Europe, plus regulatory data/exclusivity protections. There isn’t a single “Stelara patent expiry date” to quote because: - There are several patent families (composition, manufacture, methods of use, formulations, etc.). - Patent expiry dates depend on the specific patent, any term extensions, and legal status in each jurisdiction. - In addition to patents, biologic-specific data exclusivity and, in the EU, potential market exclusivity can affect biosimilar entry. Rough guidance (not exact dates): - United States: Biologics data exclusivity provides 12 years from FDA approval (Stelara was approved in 2009, so that data exclusivity would be around 2021). However, individual patent expiries (for ustekinumab composition, uses, etc.) can be later or earlier depending on term extensions and litigation. So the real “effective” protection could extend into the mid-to-late 2020s or beyond for certain patent families. - Europe: The EU generally provides data protection for biologics (often around 10 years, with possible extensions for pediatric investigations and other regulatory extensions) and patent terms can be extended via supplementary protection certificates (SPCs). Thus, European patent expiry can vary and may extend into the 2020s or 2030s for some families. If you want precise dates, I can look these up from patent databases. Would you like me to fetch the current, official expiry dates for the main ustekinumab patent families in the US and EU and list them with their status (expired, active, expired but under litigation, etc.)?
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