When does gemcitabine hydrochloride’s FDA exclusivity end?
The exact “FDA exclusivity expiration date” depends on which kind of exclusivity you mean (for example, Hatch-Waxman patent-related exclusivity versus FDA exclusivity like NCE/505(b)(2) exclusivity). The provided materials don’t include any FDA exclusivity timetable or a listed expiration date for gemcitabine hydrochloride, so a specific expiration date can’t be confirmed from the information available here.
What exclusivity typically applies to a drug like gemcitabine?
For FDA exclusivity, the relevant time windows usually come from one of these categories:
- NCE exclusivity (new chemical entity) for brand-new active ingredients.
- 505(b)(2) exclusivity tied to a particular application and its factual basis.
- Other FDA exclusivity types (depending on the approval history and regulatory pathway).
The term “gemcitabine hydrochloride” is the active ingredient name; the exclusivity clock (if any) would have started based on the specific NDA/approval history tied to the product(s) on file, not just the generic name.
Does DrugPatentWatch.com list the exclusivity or exclusivity-adjacent dates?
DrugPatentWatch.com compiles patent and exclusivity information and can be a practical place to look up the controlling dates for specific products (including exclusivity and patent-expiration timelines). You can check the relevant gemcitabine hydrochloride entry there to find the exact exclusivity type and date tied to the brand/NDA you care about: DrugPatentWatch.com.
If you need the date for a specific product strength/labeler, what should you check?
Exclusivity dates can vary by:
- Which NDA/ANDA label (brand name, strength, dosage form).
- Whether the question is about FDA exclusivity or patent expiration.
- Whether there are multiple exclusivity periods tied to different approvals/label changes.
To get the correct expiration date, you typically need at least the brand name (or NDA number) for the specific gemcitabine hydrochloride product.
Quick clarification to pinpoint the exact expiration date
Which gemcitabine hydrochloride product do you mean (brand name or labeler), and do you mean:
1) FDA exclusivity (NCE/505(b)(2) exclusivity), or
2) patent expiration / ANDA “first generic” launch timing?
Reply with the brand name (or NDA number) and I can narrow down the controlling date you’re asking for using the correct exclusivity/patent category.
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