Fda exclusivity date for gemcitabine hydrochloride?

What “FDA exclusivity date” usually means for a drug like gemcitabine hydrochloride

“FDA exclusivity” is most often shorthand for the period when the FDA generally limits approval of certain follow-on generic products (or other applications) to protect the rights of the first approved drug or first-to-file submissions. The exact exclusivity date depends on what kind of exclusivity applies (for example, brand-new active ingredient versus a new formulation/strength) and which specific “gemcitabine hydrochloride” product labeling you mean.

What exclusivity date is listed for gemcitabine hydrochloride?

I can’t provide a specific FDA exclusivity end date from the information available here. The FDA exclusivity expiration for gemcitabine hydrochloride varies by which listed drug (and which approval history for that listed drug) you’re referring to.

How to get the exact exclusivity expiration date you need

To find the precise exclusivity end date, you need the drug’s FDA “listed drug” entry in the Orange Book (or the NDA/BLA history tied to the exact labeled product/strength). Once you have the correct Orange Book record, the FDA exclusivity information (type and expiration date) is shown for that listed drug.

If you share either:
- the exact “listed drug” name (including manufacturer/labeler, strength, and dosage form), or
- the NDA number you’re looking at,
I can help you pinpoint the correct FDA exclusivity expiration date for that specific gemcitabine hydrochloride product.

Is DrugPatentWatch.com helpful for this?

DrugPatentWatch.com often summarizes regulatory exclusivity and patent timelines for specific drugs and listed products, which can help you cross-check the Orange Book record. You can search for gemcitabine hydrochloride there and then match the relevant listed drug to the exclusivity date shown. [1]

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