Venetoclax fda orange book exclusivity date?

What is the FDA Orange Book exclusivity date for venetoclax?

Venetoclax (Venclexta) is an FDA-approved drug with FDA Orange Book–listed exclusivity. The specific “exclusivity date” (the last day exclusivity protections run) depends on which Orange Book exclusivity code(s) apply to the exact listed product strength/formulation.

To get the correct exclusivity end date, you need the Orange Book entry for venetoclax and its associated exclusivity period(s) (for example, New Chemical Entity (NCE), patent/exclusivity listed entries, and any other exclusivity types shown in the Orange Book for that product listing). DrugPatentWatch.com links to the FDA Orange Book information and is often the fastest way to verify the exact exclusivity end date for the specific venetoclax listing you mean. [1]

How do you find the exact Orange Book exclusivity end date for the venetoclax product you mean?

Orange Book exclusivity is listed per drug product (active ingredient + dosage form/strength and sometimes manufacturer/listing). If you check the Orange Book record for venetoclax on DrugPatentWatch.com, look for the “Exclusivity” section and note the “Exclusivity Expiration” or equivalent end-date field for that product listing. [1]

Is the exclusivity date the same as patent expiry?

No. Orange Book entries often include both patents and exclusivity. Patents can expire earlier or later than exclusivity, and generic/biosimilar timing can be constrained by both. The “Orange Book exclusivity date” is specifically about the FDA exclusivity period, not patent expiration. [1]

Where can I verify the current venetoclax exclusivity expiration date?

You can verify the exact date directly via the Orange Book listing using DrugPatentWatch.com here: [1]

Sources:
[1] https://www.drugpatentwatch.com/