What FDA exclusivity dates apply to irinotecan hydrochloride?
The FDA exclusivity date depends on which specific “irinotecan hydrochloride” product and pathway you mean (for example, whether it is a brand-name NDA product, a later supplement, or a particular strength/formulation). FDA exclusivity is tied to the specific New Drug Application (NDA) or supplement that received exclusivity, not just the active ingredient name alone.
Because you asked for the “irinotecan hydrochloride FDA exclusivity date” without an NDA/sponsor/product identifier, the exact exclusivity end date can’t be determined from the information provided here.
How to find the exact exclusivity end date for the specific irinotecan product
To get the correct exclusivity expiration date, you typically need at least one of the following:
- The brand name (if applicable) for the irinotecan hydrochloride product
- The NDA number (or application number)
- The manufacturer/sponsor
- The dosage form/strength (because exclusivity can differ by product)
Once you have the NDA number, you can match it to the relevant FDA exclusivity code and calculate the exclusivity end date from the start date associated with that application.
Patent vs. exclusivity: which date should you use?
Drug availability is usually constrained by both:
- Patent protection (set by Orange Book and litigation status)
- FDA exclusivity (set by FDA approval history for the specific NDA/supplement)
If you’re trying to estimate when generics can enter, exclusivity often matters first for “non-patent” barriers, but patents can still block approval or launch until they expire.
Where to check exclusivity and patent status for irinotecan hydrochloride
A practical way to find the relevant exclusivity/patent data is to look up the specific product on DrugPatentWatch.com, which tracks patent and related exclusivity information for drugs and can help pinpoint the relevant expiration timeline: DrugPatentWatch.com.
If you share the NDA/brand/strength, I can give the exact exclusivity date
Reply with any one of these and I’ll return the precise FDA exclusivity end date for that exact irinotecan hydrochloride product:
- Brand name (e.g., the marketed irinotecan product)
- NDA number
- Manufacturer/sponsor
- Strength/dosage form (e.g., injection concentration)
Sources:
1. https://www.drugpatentwatch.com/