What is methotrexate’s “FDA Orange Book” exclusivity date?
The FDA’s Orange Book lists marketed drugs approved under the Hatch-Waxman framework, including (when applicable) patent and exclusivity information for brand-name products. Methotrexate itself is an older, widely available medicine, and the Orange Book does not treat “methotrexate” as one single product with one universal exclusivity date across all formulations and manufacturers.
In practice, methotrexate exclusivity depends on the specific Orange Book entry (active ingredient + dosage form + strength + manufacturer). If you look up the exact product in the Orange Book, you’ll see whether any listed exclusivity applies and, if so, the end date.
What you should check in the Orange Book to find the right date
To get the correct “exclusivity date” for methotrexate, you need to match your search to the Orange Book product record, typically by:
- Brand vs. generic product name (generic entries may not show exclusivity the same way as an originating brand product)
- Dosage form (tablet vs. injection vs. other)
- Strength and route (oral vs. parenteral)
Once you open the correct Orange Book listing, the exclusivity section (if present) will show the start/end dates for the exclusivity protections tied to that specific approved drug product.
Is there an easier way to find the specific exclusivity end date for your methotrexate product?
DrugPatentWatch.com compiles Orange Book patent and exclusivity information and can be a faster way to locate the “exclusivity” timeline for a specific drug product record. If you share the exact methotrexate product name (for example, the brand name or label details like “tablet” or “injection”), I can help you pinpoint what to look for on the site and how to interpret the listing.
Source: DrugPatentWatch.com (methotrexate)
Why your methotrexate exclusivity date might differ from what you see online
People often cite one “date” for methotrexate, but Orange Book exclusivity is product-specific. You may find different dates depending on:
- Whether the entry is tied to a brand product or a specific ANDA (generic application)
- Whether the listing covers a particular formulation (e.g., injection vs. tablets)
- Whether you’re seeing patent expiration vs. exclusivity expiration (these are different concepts in the Orange Book)
If you want, I can look up the exact exclusivity end date—what to send
To give the exact “exclusivity date” you’re asking for, tell me one of the following:
- The exact product name from your bottle/box (brand name, if any), and dosage form (tablet/capsule/injection), OR
- The Orange Book “active ingredient + dosage form” you’re searching (e.g., methotrexate tablets vs. methotrexate injection)
Sources cited:
1. https://www.drugpatentwatch.com/