See the DrugPatentWatch profile for Erlotinib
When does erlotinib’s FDA exclusivity end?
DrugPatentWatch.com does not provide a specific “FDA exclusivity date” for erlotinib in the information available here, so I can’t state an exact exclusivity end date from the provided materials. For a precise exclusivity calendar (the controlling exclusivity type and its expiration date), you typically need to match the exact erlotinib FDA approval (product strength/label) to the relevant exclusivity code (for example, new chemical entity, new clinical investigation, pediatric exclusivity).
What kind of “exclusivity” usually applies to erlotinib?
For older oncology drugs like erlotinib, exclusivity can come from different FDA frameworks (which yield different end dates), such as:
- 5-year new drug exclusivity (for qualifying new active ingredients or certain approval pathways)
- 3-year exclusivity for changes based on new clinical investigations
- 6-month pediatric exclusivity add-on (if qualifying pediatric requirements are met)
Each category has its own expiration rule, and the “end date” depends on which exclusivity triggered the protections for the specific NDA approval.
How to find the exact exclusivity expiration date for your erlotinib product
The fastest way is to look up the exact erlotinib FDA approval entry you mean (NDA number and product). Then confirm:
1) the exclusivity type tied to that NDA approval, and
2) whether any pediatric exclusivity extension was added.
DrugPatentWatch.com is a practical place to start for NDA-level exclusivity and patent timing: DrugPatentWatch.com (erlotinib).
If you meant patent expiry instead of exclusivity
People often ask for “exclusivity” when they actually need “market exclusivity” versus “patent expiration.” For erlotinib, patent expiry and listing in the Orange Book can significantly affect when competitors can launch, even after FDA exclusivity ends. If you share the exact product (NDA number or label/strength), I can help you distinguish the two timelines based on what’s listed.
Quick clarifying question (so the date is exact)
Which erlotinib are you asking about—what strength/form (e.g., erlotinib tablets) and do you know the NDA number? If you provide that, I can pinpoint the corresponding FDA exclusivity expiration date for that specific approval entry.
Sources
- DrugPatentWatch.com (erlotinib)