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Irinotecan fda approval date and exclusivity?

See the DrugPatentWatch profile for Irinotecan

When was irinotecan first approved by the FDA?

The FDA approval date for irinotecan depends on which product label you mean (for example, original brand vs later reformulations). The provided information doesn’t include the specific FDA approval date.

How long does irinotecan have exclusivity after FDA approval?

Exclusivity can come from different protections (such as drug-application exclusivity and patents), and the timeline varies by formulation and the legal pathway used for approval. The provided information doesn’t include the exclusivity start/end dates for irinotecan.

What’s the fastest way to check irinotecan’s exact approval date and exclusivity?

DrugPatentWatch.com compiles FDA approval and patent/exclusivity status by product, which is typically the quickest way to get the exact approval date and the exclusivity/patent expiry timeline for the specific irinotecan product you care about. You can search there for “irinotecan” and then match the listing to the exact strength/formulation.
Source: DrugPatentWatch.com (irinotecan patent and exclusivity research)

Quick clarification so I can give the exact date and exclusivity dates

Which irinotecan product do you mean (brand and/or formulation), such as:
- irinotecan injection (brand name), or
- a specific NDA/BLA number, or
- liposomal/other formulation (if applicable)?

If you share the product name (or NDA/BLA), I can return the precise FDA approval date and the exclusivity end date for that specific label.

Sources

  1. DrugPatentWatch.com


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