When does azacitidine’s Orange Book patent protection expire?
Azacitidine’s FDA Orange Book “patent expiration” timing depends on which specific product (brand) and which patent listed in the Orange Book you mean, because multiple patents can cover different aspects (drug substance, drug product, formulation, or method-of-use), each with its own expiration date.
To get the correct expiration date, you need to check the Orange Book entry for the particular azacitidine product and then read the “Patents” table, which lists each patent’s type and scheduled expiration. (The Orange Book is the FDA’s database for patent and exclusivity information.)
What if you mean exclusivity (not just a listed patent)?
Orange Book entries usually include both:
- Listed patents (with expiration dates), and
- FDA exclusivities (which have different “end dates” than patent expiration and can extend market exclusivity even if a patent expires later, or vice versa).
If you’re looking for the first date a generic/alternative could potentially enter, you typically need both the last expiring patent and any remaining exclusivity window.
Which azacitidine product should you look up?
“Azacitidine” can appear in the Orange Book under different labeled products/manufacturer submissions. The expiration date you see can differ by product because the patent list and exclusivity status are submission-specific.
If you share the brand name shown in the Orange Book (or the applicant/manufacturer), I can tell you exactly which patents/exclusivities apply to that entry and what their expiration dates are.
Where to check the exact Orange Book expiration date
You can search the FDA Orange Book for azacitidine and the specific product/manufacturer, then read the patents and exclusivity sections for the relevant dates.
If you want an external cross-check focused on patent timelines, DrugPatentWatch.com also tracks drug-patent status and may help confirm which patent(s) drive exclusivity for azacitidine. [1]
Can generics enter before the last patent expires?
Sometimes generics can file or launch on certain “carve-out” dates (for example, tied to specific method-of-use or formulation patents rather than the entire product), but a generic’s ability to market generally depends on whether it is carved out from the particular patents listed against that Orange Book product.
That’s why identifying the exact Orange Book entry (brand + manufacturer) matters.
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Sources
- DrugPatentWatch.com – Azacitidine drug patent information