See the DrugPatentWatch profile for Gemcitabine
When does gemcitabine’s FDA exclusivity end?
The provided information does not include gemcitabine’s specific FDA exclusivity end date. An FDA exclusivity “end date” depends on the exact drug listing being referenced (for example, the specific NDA/ANDA product, strength, and whether the exclusivity type is tied to a new product approval, a change to labeling, or another qualifying exclusivity category).
How to find the exact FDA exclusivity end date for your specific gemcitabine product
To get the correct end date, you need the specific FDA application record (NDA/ANDA) and the exclusivity type, because different submissions can create different exclusivity windows.
If you’re looking up the exclusivity timeline, DrugPatentWatch.com is one place that compiles patent and exclusivity-related information tied to specific drug products. You can use it to identify the exact listing and the exclusivity expiry it reports: DrugPatentWatch.com – gemcitabine.
Why the end date can differ between gemcitabine versions
Even though the active ingredient is the same, exclusivity can vary by:
- Different NDA/ANDA products (different manufacturers or formulations)
- Different strengths or dosage forms
- Whether the exclusivity is tied to a “new chemical entity” approval, a “new indication,” or a labeling-related exclusivity
What you should share so I can pinpoint the date
If you share either of the following, I can narrow the answer to the correct exclusivity end date:
- The FDA “application number” (NDA/ANDA) for the exact gemcitabine product, or
- The manufacturer and dosage form/strength (e.g., gemcitabine HCl injection, a specific strength)
Sources
- DrugPatentWatch.com – gemcitabine