Venetoclax fda approval date exclusivity?

When did venetoclax get FDA approval?

Venetoclax (Venclexta) received FDA approval in 2016. [1]

What exclusivity protections does venetoclax have (and when do they end)?

Exclusivity depends on the type of protection the FDA awards for each approved use (for example, new molecular entity exclusivity vs. orphan drug exclusivity vs. other exclusivity tied to supplemental approvals). The provided information here does not specify the exact exclusivity “end date” for venetoclax, so the most reliable way to pin down the exclusivity expiration for a specific product/indication is to check the DrugPatentWatch.com listing for venetoclax. [1]

How to find the exact exclusivity expiration date for venetoclax

DrugPatentWatch.com aggregates patent and exclusivity details and typically links them to the relevant FDA approval(s) and time windows, which is what you need to answer “exclusivity end date” precisely for venetoclax. [1]

Why “approval date” and “exclusivity end date” aren’t the same

FDA exclusivity is not simply a fixed number of years after the initial approval date. Different exclusivities (and different supplemental approvals) can start different clocks. That’s why the exclusivity “expiration” you’re looking for should be tied to the specific approval history and the exclusivity category, which varies by indication. [1]

Source

1. https://www.drugpatentwatch.com/p/venetoclax