Tagrisso loss of exclusivity?

Tagrisso (osimertinib) LOE depends on jurisdiction and on multiple patent and regulatory protections. Here’s a concise view:

- United States: The key composition-of-matter patent for osimertinib is expected to expire in the late 2020s (commonly discussed around 2027–2029), with additional related patents (e.g., methods, formulations) potentially extending protection to 2030s. Regulatory data exclusivity for a new chemical entity does not usually extend past the patent protections, so no generic tagrisso until patent terms and any settlements allow it. In short: no generic Tagrisso in the US before roughly 2027–2029, depending on patent litigation/settlements.

- European Union: Similar timing. Data protection and SPCs can push protection toward the late 2020s, with actual generic entry depending on national patent status and any SPCs or legal challenges.

- Other markets (Japan, Canada, Australia, etc.): Timing varies, but often in the same general ballpark (late 2020s) barring country-specific patents or extensions.

- Important caveat: There are multiple patent families (composition, use, formulation) and potential term extensions or settlements that can shift actual entry dates. Some markets may see later or earlier entry based on local patent status and litigation outcomes.

If you want, tell me the exact country or region you’re interested in, and I can pull the current LOE status (patent expiry dates, Orange Book listings for the US, EPO/other patent data) and summarize the likely timeline for that market.