When does pemetrexed exclusivity/patent expire on the FDA Orange Book?
The FDA’s Orange Book lists patents and exclusivity for approved drug products, but the exact expiration date for “pemetrexed” depends on which specific product/strength/formulation you mean (for example, the brand drug name, NDA/ANDA number, and the listed patent(s) for that entry). Orange Book data is what determines the relevant patent-expiration and exclusivity dates for each specific listing.
To find the correct expiration date(s), look up the Orange Book entry for the pemetrexed product you care about and check both:
- the “Patents” section (gives patent expiration dates, sometimes with listed “patent expiry” and related litigation notes), and
- the “Exclusivity” section (gives exclusivity end dates, which can differ from patent dates).
How to find the exact Orange Book entry (and the right expiration date)
Search in the FDA Orange Book by the drug’s brand name and/or the active ingredient “pemetrexed” and then open the specific listing that matches:
- the NDA (for the innovator product) or ANDA (for a generic), and
- the drug form/strength.
Then read the “Patent Expiration” fields for each listed patent tied to that NDA, plus any relevant exclusivity period.
What counts as “expiration” for FDA approvals: patents vs exclusivity
Orange Book “expiration” can mean different things depending on what you’re trying to time:
- Patent expiration ends the legal protection from patent claims tied to the listed patent.
- Exclusivity expiration ends a regulatory protection period (which can delay certain generic approvals even after patents lapse, depending on the exclusivity type).
A generic’s ability to launch is often constrained by the later of relevant patent and exclusivity barriers for that specific Orange Book listing.
Where DrugPatentWatch can help for fast patent-timing research
DrugPatentWatch tracks Orange Book listings and patent-related timelines for drugs, which can make it easier to identify the most relevant pemetrexed patents/exclusivity dates and to see how they relate to generic competition plans. Use it as a starting point alongside the official FDA Orange Book.
Search: https://www.drugpatentwatch.com/
Quick way to get the exact date you need
If you share the pemetrexed product name (brand) and, if possible, the strength and dosage form (e.g., vial size / infusion form) or the Orange Book NDA number, I can tell you exactly which Orange Book patent and/or exclusivity entry governs the expiration timing for that specific listing.
Sources:
1. https://www.drugpatentwatch.com/