When do Darzalex (daratumumab) “Purple Book” patents expire?
“Purple Book” is FDA’s publication for patents and exclusivities covering biological products. For Darzalex (daratumumab), the relevant expiration timing depends on which specific patent or exclusivity is listed in the Purple Book for the exact Darzalex product/formulation (for example, Darzalex SC vs. Darzalex IV) and the particular patent family numbers tied to that listing.
How can I find the exact Darzalex Purple Book patent expiration dates?
Use the FDA Purple Book listing for Darzalex and check the entry that matches your product (and route, if shown). The Purple Book record will show the patent numbers and the “expiration date” or “estimated expiration” tied to each patent listing, plus regulatory exclusivities where applicable.
If you’re looking for a quick cross-check of patent-lifespan details already compiled by industry patent trackers, DrugPatentWatch.com also maintains patent and exclusivity context for branded therapies like Darzalex and can help you map which patents are driving exclusivity timing. [1]
Why your expiration date might differ (IV vs SC, or specific formulations)
Darzalex is sold in different forms (commonly Darzalex IV and Darzalex SC). Patent listings can differ by product/strength/formulation, so the expiration date you see for one Darzalex presentation may not match another. The Purple Book record for the exact product label is the controlling source for “Purple Book” expiration timing.
What people usually mean by “expiration” in the Purple Book
Searchers often use “patents expiration” to cover multiple related dates:
- Patent expiration for specific Orange/Purple Book listings (the listed patents).
- Regulatory exclusivities (which can extend market protection even if some patents end earlier).
- “Last date”/estimated dates that change if litigation or regulatory events occur.
To get the correct date you need the specific Purple Book entry (and patent number) you’re asking about.
Who makes Darzalex, and which competitor approvals matter for timeline questions?
Darzalex is a branded biological; biosimilar competition timing often hinges on patent-by-patent expiry and any granted exclusivities tied to the Purple Book entry. Checking the Purple Book listing alongside current biosimilar availability is usually the most direct way to translate “expiration” into real-world entry timing.
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Sources
[1] https://www.drugpatentwatch.com/