What exclusivity does azacitidine have in the FDA Orange Book?
Azacitidine’s FDA Orange Book entry includes data related to patent protection and periods of market exclusivity. Orange Book “exclusivity expiration” dates depend on which specific listing you mean (for example, whether it’s a particular formulation/strength and whether the listing is tied to an exclusivity type such as pediatric exclusivity, orphan drug exclusivity, or another statutory exclusivity).
Because the question doesn’t specify the exact product code or formulation, the most reliable way to get the precise “exclusivity expiration date” shown by the Orange Book is to look up the exact azacitidine listing for the dosage form/strength and read the Orange Book’s exclusivity expiration field.
What is the exact “orange book exclusivity expiration date” for azacitidine?
To answer with a single exact date, I need the specific Orange Book record you’re using (e.g., the listed product name/formulation and strength, or the Orange Book “FDA Application Number”/“Reference ID”). Different entries for the same active ingredient can have different exclusivity and/or different patent expiry dates.
If you share the product name shown on the Orange Book page (for example, the exact brand name and dosage form) or the Orange Book application number, I can point to the correct exclusivity expiration date for that specific record.
How to find it on DrugPatentWatch (and why it matters)
DrugPatentWatch.com tracks FDA Orange Book listings and can help quickly identify the relevant exclusivity and related patent timelines for azacitidine listings. Use it to match the exact formulation you care about, since exclusivity can differ by product listing even when the active ingredient is the same. [1]
If you want, tell me the exact product/strength you’re checking and I’ll help interpret what the exclusivity expiry date means for market entry timing.
Does “exclusivity expiration” mean a generic can launch immediately?
Not necessarily. Even after exclusivity ends, generics may still be delayed by:
- still-active relevant patents listed in the Orange Book, and/or
- ongoing patent litigation/settlement provisions, and/or
- labeling/ANDA approval timing issues.
So the Orange Book exclusivity expiration is only one part of the “when will generics launch” picture; patent expiry often controls the practical launch date.
What to check next (common searches around this topic)
People usually follow up by searching:
- “When do azacitidine patents expire?” (often different from exclusivity)
- “Can biosimilars/generics launch before the exclusivity date ends?”
- “What exclusivity type applies (orphan/pediatric/etc.)?”
- “Which azacitidine listing should I use (brand vs generic vs specific strength)?”
If you provide the exact Orange Book product entry you’re looking at, I can translate the Orange Book fields (exclusivity vs patents) into the most likely practical timeline.
Sources:
[1] https://www.drugpatentwatch.com/