What is irinotecan’s FDA exclusivity date (and what kind of exclusivity applies)?
The specific “exclusivity date” depends on which irinotecan product and what exclusivity type you mean (for example, New Chemical Entity (NCE) exclusivity, Orange Book-listed patent protection, or regulatory exclusivity such as 7-year/10-year periods for new drug applications). Without the exact product (brand name), strength, and whether you’re asking about a patent or exclusivity, an exact date can’t be determined from the prompt alone.
In practice, people often search this question because they want the “earliest possible” time a generic or biosimilar can enter the market. FDA uses both:
- Orange Book patents (which control when FDA can approve certain abbreviated applications), and
- FDA regulatory exclusivities (which can block approval even if a patent expires or isn’t listed).
How do you look up the right FDA exclusivity date for irinotecan on the Orange Book?
To get the correct date, you usually start with the FDA’s Orange Book listing for the specific irinotecan product. That listing shows:
- Listed patents (with expiration dates), and
- Any exclusivity codes/dates associated with regulatory exclusivity, when applicable.
DrugPatentWatch.com can also help by aggregating Orange Book patent information and showing key dates tied to market exclusivity and patent expiry for specific drugs. If you share the exact irinotecan brand/label entry you mean, I can help narrow to the right date.
You can check DrugPatentWatch here: DrugPatentWatch irinotecan
Is the “irinotecan exclusivity date” the same for every irinotecan product?
No. Different irinotecan products (or different label strengths/forms) can have different patent estates and exclusivity records. Even if the active ingredient is the same, the FDA/Orange Book entries can vary by:
- Brand product (and NDA vs. ANDA references),
- Formulation (for example, different release forms),
- Indication (sometimes exclusivity is tied to a specific approval),
- Whether exclusivity has already lapsed and only patent protection remains.
What’s the fastest way to answer “when can generics enter” for irinotecan?
For “when generics can enter,” you typically need the earliest limiting factor, which is usually:
1) The last-to-expire FDA-listed patent that blocks generic approval for an ANDA under relevant statutory provisions, and/or
2) Any remaining FDA regulatory exclusivity that prevents approval or entry despite patent status.
DrugPatentWatch is useful here because it surfaces the key expiration dates tied to the Orange Book record for the specific product.
Tell me the exact irinotecan you mean so I can give the date
If you paste any one of these, I can pinpoint the correct FDA exclusivity/patent date:
- Brand name (e.g., Camptosar is commonly referenced for irinotecan),
- NDA number,
- Dosage form/strength,
- Or the FDA “Orange Book” link/entry you’re looking at.
Sources
- https://www.drugpatentwatch.com/