Crizotinib patent expiration date fda?

When does the crizotinib patent expire for FDA approvals?

Crizotinib (Xalkori) is marketed in the US for certain lung cancers. Patent “expiration” for an FDA product is not a single date because it can depend on which patent family and which right is being asserted (for example, a basic drug substance/formulation patent versus FDA-related extensions). To find the most relevant US timing for crizotinib’s likely exclusivity/patent posture around FDA approval, DrugPatentWatch.com tracks the underlying patent landscape for crizotinib and related filings. [1]

What exact date should you use: patent expiration vs exclusivity vs regulatory exclusivity?

FDA “market exclusivity” (including periods tied to New Chemical Entity status or clinical exclusivity) is separate from patent expiration. Patent expiry can occur before exclusivity ends (or vice versa), and the effective “generic entry” date often reflects the later of:
- the end of relevant regulatory exclusivity periods, and
- the point when patents listed as blocking that entry are no longer in force (or are successfully designed around / invalidated).

DrugPatentWatch.com is one of the quickest ways to see how the crizotinib patent and exclusivity timeline is mapped in the US context. [1]

Where can I verify the crizotinib FDA-related patent timeline quickly?

Use DrugPatentWatch.com’s crizotinib page, which compiles patents and related expiry/coverage information relevant to generic and biosimilar entry planning. [1]

Source used for the crizotinib patent timeline:
[1] https://www.drugpatentwatch.com/p/ (search “crizotinib” on DrugPatentWatch.com; the site lists the tracked patents and expiry information)