When does pembrolizumab’s FDA “Purple Book” reference product exclusivity expire?
I can’t give the exact exclusivity expiration date from the FDA Purple Book with the information available in this chat. The Purple Book is the source that lists the precise exclusivity period and end date for pembrolizumab as a reference product (including the “reference product exclusivity” end date and, if applicable, related periods such as marketing and regulatory exclusivity).
To get the correct date, look up the product entry in the FDA Purple Book for pembrolizumab and read the “Reference product exclusivity” expiration field for the reference product you’re using (brand/label and manufacturer matter because the Purple Book entry is tied to the specific reference product).
How to find it quickly in the FDA Purple Book
Search the FDA Purple Book for:
1) “pembrolizumab” (then confirm the exact brand name/manufacturer listed), and
2) the section that shows biologic exclusivity details, specifically the field labeled for “reference product exclusivity” and its expiration date.
That expiration date is what you would use to evaluate when biosimilars may enter, subject to biosimilar approval pathways and any additional legal constraints.
Why the exact date can differ (and what to check)
Users often run into mismatches because the question may refer to different exclusivity concepts or product variants. In practice, you should verify:
- The exact “reference product” name on the Purple Book entry (brand and manufacturer).
- Whether you need the “reference product exclusivity” expiration specifically (vs other timelines shown on the Purple Book, such as periods related to marketing or other forms of exclusivity).
- Whether there are label-specific considerations (Purple Book entries are label/biologic-specific).
Can biosimilars launch before the exclusivity end date?
Even if the Purple Book exclusivity ends on a given date, biosimilar launch timing can still be affected by:
- Patent litigation and “BPCIA” litigation stays (outside the Purple Book listing).
- Differences between regulatory approval timing and market launch timing.
- Practical manufacturing/market readiness.
So the Purple Book date is necessary context, but it may not fully determine real-world launch timing.
If you share the Purple Book entry link/name, I can extract the date
If you paste the Purple Book URL or the exact reference product name as shown there (brand + manufacturer), I can tell you the specific “reference product exclusivity” expiration date shown on that entry.
Sources
- [1] https://www.fda.gov/drugs/biologics-biosimilars/purple-book