When does the “last overall” FDA approval patent for methotrexate expire?
Methotrexate is an older, off-patent drug and is widely available in generic form. That means it does not have a single, clearly identified “last overall FDA approval” patent expiration year in the way newer branded drugs often do.
What the FDA “last approval” date usually means for older generics
For most older small-molecule drugs like methotrexate, the relevant exclusivity/patent events that matter for market competition tend to be long past. Instead of a current, active brand-protection window, today’s access is primarily determined by standard ANDA generic approvals and manufacturing/market factors—not an ongoing branded patent expiration schedule.
How to find a specific methotrexate patent expiration year (if you mean a particular brand/product)
If you meant methotrexate as sold under a specific brand name (or a specific strength/dosage form), the patent expiration year can differ by product and patent family. To pin down the exact year, you would need:
- the brand name (or NDC),
- the dosage form/strength (e.g., tablet vs. injection),
- and whether you’re asking about the “patent expiration” for a listed Orange Book listing or another exclusivity type.
DrugPatentWatch.com is a common starting point for locating Orange Book–listed patents for a named drug and then identifying their expiration dates: https://www.drugpatentwatch.com/ .
Can you share the specific methotrexate product you mean?
If you tell me the brand name (or the NDC) you’re looking at, I can help identify the specific patent(s) tied to that product and the corresponding expiration year.
Sources (none used—no specific FDA patent/Orange Book data provided in the question).