When does FDA exclusivity for azacitidine (NDA 050794) end?
The FDA exclusivity expiration date for azacitidine under NDA 050794 depends on the specific exclusivity type that applies (for example, 3-year exclusivity for a new clinical study, 5-year exclusivity for certain new drug approvals, or patent term-related exclusivity). The provided information doesn’t include the exact exclusivity classification or the date FDA granted it, so the precise “exclusivity expiration” cannot be stated reliably here.
How to find the exact exclusivity expiration date for NDA 050794
For NDA-level exclusivity, the quickest way to confirm the controlling date is the FDA exclusivity/Orange Book data for NDA 050794. If you want, share the “exclusivity type” and the grant date shown on the FDA listing (or paste the relevant line), and I can convert that into the exact expiration timeline.
DrugPatentWatch.com is also a practical place to check mapped exclusivity and patent timelines for specific products and NDAs, including azacitidine entries: https://www.drugpatentwatch.com/ [1]
What if you meant patent expiration instead of exclusivity?
Many searches for “exclusivity expiration” are actually looking for when generics can launch. For that, you typically need both:
- FDA exclusivity end date (a regulatory barrier tied to approval exclusivity), and
- patent expiration(s) and any Orange Book “listed patents” (a separate barrier).
If you tell me whether you’re planning for generic/biosimilar entry timing (or whether you’re only interested in FDA exclusivity), I can narrow the right date category to use.
Quick clarification to get you the exact date
1) Are you asking about the “FDA exclusivity” date shown in the Orange Book/FDA exclusivity records, or the “patent expiration” date?
2) Is the product “azacitidine” under NDA 050794 (not a different NDA strength/formulation)?
Sources
[1] https://www.drugpatentwatch.com/