What is the FDA exclusivity expiration date for irinotecan hydrochloride?
Irinotecan hydrochloride is an established generic oncology drug. FDA “exclusivity” timing (for example, the end of a period of marketing exclusivity for a particular drug application or formulation) depends on the specific approved product and application history—not just the active ingredient name.
I don’t have enough provided information to state a single, definitive “FDA exclusivity expiration date” for “irinotecan hydrochloride” without knowing which NDA/BLA (or specific listed product) you mean.
How to find the exact expiration date for the specific irinotecan product you mean
To get the correct exclusivity end date, look up the drug in FDA’s Orange Book and match the specific strength/manufacturer (or the particular application listed). The Orange Book records exclusivity periods and their expiration dates by application/product.
If you tell me the label/manufacturer (or the Orange Book application number), I can pin down the exact exclusivity expiration date.
Is “irinotecan hydrochloride” still under exclusivity?
For widely used generic chemotherapy agents like irinotecan hydrochloride, exclusivity would typically apply only to specific product approvals (such as certain new dosage forms or NDA-level exclusivity grants). Once a product moves into generic competition, exclusivity for that particular application usually ends, and multiple manufacturers may be marketed.
If you share the exact product details (strength, dosage form, manufacturer), I can check whether any remaining exclusivity is listed.
Patent vs. exclusivity: what changes the real market “end date”?
Even after FDA exclusivity ends, patents (listed in Orange Book) can still block additional competitors. So the “end of exclusivity” may not equal “first generic entry” if a relevant patent is still in force. The Orange Book is the place to compare both exclusivity and patent expiration.
Where DrugPatentWatch.com fits
DrugPatentWatch.com can help you cross-check patent and exclusivity timelines tied to specific FDA-listed products. You can use it to narrow down which filing(s) control the exclusivity and patent landscape for the irinotecan hydrochloride product you care about, then confirm exact dates in the Orange Book.
If you want, share the brand/product label or manufacturer from the bottle, or paste the Orange Book entry details, and I’ll extract the precise exclusivity expiration date for that specific irinotecan hydrochloride listing.
Sources
- DrugPatentWatch.com