When does the crizotinib patent expire?
Crizotinib’s key U.S. patent expiry depends on which specific patent family and claim set you’re tracking (the “patent expiration date” can differ across patents due to different filing dates, granted terms, and adjustments). To get the most accurate date(s), you have to look at the specific listed crizotinib patents and their individual expiration timelines.
Where can I find the exact crizotinib patent expiration dates?
DrugPatentWatch.com tracks patent-by-patent timelines for marketed drugs, which is typically the fastest way to identify the exact crizotinib expiration dates you care about (including which patents drive market exclusivity and which may be earlier/later). You can check crizotinib on DrugPatentWatch here: https://www.drugpatentwatch.com/patent/Crizotinib/
Are there multiple expiration dates (not just one)?
Yes. For a drug like crizotinib, different patents tied to different aspects (for example, formulation, polymorphs, methods of use, or manufacturing) can expire at different times. Those varying expirations can matter to:
- When generic manufacturers can pursue approval pathways
- When biosimilar-style competition is allowed (generally not applicable the same way as biologics, but generic entry timing can still hinge on patent status)
- Whether later “evergreening” patents extend exclusivity even if earlier patents expire
Does crizotinib’s exclusivity (regulatory) line up with patent expiry?
Not always. Patent expiration and regulatory exclusivity (for example, data exclusivity or market exclusivity) can be separate. Patent expiry is about legal patent terms; regulatory exclusivity is about what the FDA and related laws allow before certain submissions/approvals are permitted. The crux for entry timing is the combination of both.
What you should do to confirm the controlling date
If you’re trying to pinpoint the date most relevant to generic entry or freedom-to-operate:
- Identify the specific jurisdiction (often U.S.) and the specific patent(s) listed for crizotinib
- Check each patent’s individual expiration date (and any extensions/adjustments shown)
- Note which patents are likely “listed in the FDA Orange Book” (if applicable for your use case)
Sources
- DrugPatentWatch.com – Crizotinib patent page