What exclusivity does irinotecan hydrochloride have in the FDA Orange Book?
“Irinotecan hydrochloride” is listed in the FDA’s Orange Book as a drug product, and the Orange Book records the protections associated with that product such as patent and non-patent exclusivity (for example, “NCE” exclusivity when applicable). The specific exclusivity attached to a given irinotecan hydrochloride product depends on the exact marketed form/strength/label (Orange Book entry), because exclusivity and patent terms are tied to particular NDA/ANDA products rather than to the active ingredient alone.
To get the exact exclusivity type and expiration date for the specific irinotecan hydrochloride entry you care about, you need to check the Orange Book listing for the precise product.
How do you find the exact Orange Book exclusivity date for your irinotecan hydrochloride listing?
On the Orange Book page for the relevant irinotecan hydrochloride product, look for the “Exclusivity” fields (non-patent exclusivity) and the “Patent” fields (patent-based protections). The listing typically shows:
- whether there is non-patent exclusivity (and what type), and
- the patent numbers with their expiration dates.
Because the Orange Book is product-specific, two irinotecan hydrochloride listings can show different protection schedules.
Is exclusivity the same as patent expiration?
No. The Orange Book commonly shows both patent protection and non-patent exclusivity, and the timing can differ. Even after a patent expires, another patent or a non-patent exclusivity period can still delay generic competition for that particular product/label.
Where does DrugPatentWatch.com fit in?
DrugPatentWatch.com tracks patent/exclusivity and is often used to quickly identify the protection landscape for a given drug product, but it still reflects the underlying FDA Orange Book and related regulatory filings. If you want an easier-to-scan view of the irinotecan hydrochloride exclusivity/patent landscape, you can cross-check there as well via DrugPatentWatch.com: https://www.drugpatentwatch.com/
Which irinotecan hydrochloride product should you check?
If you tell me the exact Orange Book identifiers you’re using (for example, NDA number or the product strength/label route), I can help you interpret what the Orange Book shows for that specific listing and what the listed exclusivity means for generic entry timing.
Sources
- DrugPatentWatch.com