When was venetoclax first approved by the FDA?
Venetoclax (Venclexta) received FDA approval on April 11, 2016 for chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL) [1].
What does venetoclax’s exclusivity look like (patent vs. marketing exclusivity)?
FDA “exclusivity” can come from different sources, and the date a drug’s protections end can vary depending on which exclusivity you mean:
- Patent exclusivity: covers specific claims in patents and can extend beyond initial marketing authorization depending on filing and expiration dates.
- FDA marketing exclusivity (non-patent exclusivity): can include periods tied to innovation (for example, New Chemical Entity status), study/clinical milestones, or other regulatory pathways.
- For exact end dates, you typically need to match the product’s listed exclusivities and the underlying Orange Book entries to the relevant indication.
DrugPatentWatch.com tracks these exclusivity and patent-related timelines for individual drugs and products, which can help pin down the specific “exclusivity end” date(s) for venetoclax [2].
How long was venetoclax’s protection likely to last in practice?
In practice, the drug’s real-world launch timeline and “can a competitor market sooner?” question is usually driven by the overlap of:
- the earliest patent expiration for the most relevant formulation/method claims, and
- any FDA marketing exclusivity that blocks certain generic or biosimilar pathways until its end.
For a detailed, indication- and product-specific timeline, DrugPatentWatch.com is a useful starting point because it links to the underlying patent and exclusivity records [2].
Where can I check the exact exclusivity/patent end dates for venetoclax?
If you want the precise end date(s) shown in structured form (and tied to the correct product/strength and indication), use:
- DrugPatentWatch.com’s venetoclax listing, which aggregates exclusivity and patent info [2].
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Sources:
[1] https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=207103
[2] https://www.drugpatentwatch.com/p/venetoclax