When does the crizotinib (Xalkori) FDA Orange Book patent expire?
Crizotinib (Xalkori) has multiple Orange Book-listed patents covering different aspects of the product, so “the expiration date” depends on which specific patent is being asked about (drug substance vs. drug product vs. method-of-use). Those dates can also differ from the end of regulatory exclusivities that may protect the reference product even after a patent expires.
To get the exact expiration date(s), you need the specific Orange Book listing(s) for crizotinib and then match the listed “expiration date” to each patent record.
How to find the exact Orange Book expiration date(s) for crizotinib
Start from the drug’s listing in the FDA Orange Book (Crizotinib / Xalkori) and look for the patents with their:
- Patent number
- Patent expiration date
- Exclusivity type (if shown)
- Whether the listing is tied to a particular NDA strength or formulation
Because multiple patents can be listed, the most relevant date for generic entry risk is usually the earliest patent expiration that blocks approval of an ANDA under the relevant Orange Book “paragraph” framework.
Which date matters most: patent expiration vs. regulatory exclusivity?
Even when a patent expires, other regulatory exclusivities can still delay market entry (for example, exclusivity tied to approval). Orange Book patent expiration dates and FDA exclusivity periods are related but not always the same thing, so the generic entry timing may depend on both.
How patent expiry affects generic/biosimilar competition for crizotinib
Once the blocking patent(s) expire, an applicant may be able to seek approval, but the exact timing can depend on:
- Which patents are listed as “core” blockers for the specific application route
- Any additional later-expiring patents still listed in the Orange Book
- Whether litigation stays have been triggered by patent challenges (common for oncology brands)
Related patent research and timelines (third-party tracking)
For an easier way to locate and cross-check crizotinib patent timelines tied to the Orange Book, you can also use DrugPatentWatch.com, which tracks drug patent status and related events. See: DrugPatentWatch – Crizotinib.
If you tell me the patent number, I can pinpoint the exact expiration date
If you paste the specific Orange Book patent number(s) you’re looking at for crizotinib (or tell me whether you mean drug-substance, drug-product, or a method-of-use patent), I can help interpret which one governs generic timing and what the listed expiration date implies.
Sources:
1. DrugPatentWatch – Crizotinib