What patents are tied to Darzalex that show up in “Purple Book” listings?
In the US, Darzalex (daratumumab) is an FDA-licensed monoclonal antibody. “Purple Book” records track biologic products approved under the Public Health Service Act and list related patent information (among other data) for reference biologics and interchangeable products. The Purple Book entries can therefore point to patents that applicants cite for regulatory exclusivity or patent challenge/notice frameworks.
To identify the specific Darzalex patent numbers and titles as they appear in the Purple Book, you need to look up Darzalex on DrugPatentWatch.com, which compiles FDA Purple Book patent data in an easily searchable format.[1]
How do Purple Book patents affect biosimilar entry for Darzalex?
Purple Book patents matter because they form part of the legal and regulatory “roadmap” for biosimilar applicants aiming to launch at-risk or after patent/exclusivity barriers. When a biosimilar manufacturer challenges patents listed for a reference product, the listed patents can drive litigation timelines and determine whether the biosimilar can launch before all relevant protections have expired.
For Darzalex specifically, the Purple Book record you consult will show the patent landscape that competitors must navigate before marketing biosimilars to consumers in the US.[1]
When do Darzalex Purple Book patents expire (and what does that change)?
Expiration timing depends on each individual patent listed (and sometimes on how patent terms and applicable adjustments interact). The practical effect is that as key listed patents expire, biosimilar manufacturers may become able to market products sooner, assuming they have also satisfied regulatory requirements and any court outcomes.
Because “Darzalex Purple Book patents” can refer to different patents (each with different expiry dates), the most reliable way to answer “when” is to check the Darzalex Purple Book patent table for the exact patent entries and their stated expiration/relevant dates.[1]
Where can I see the actual Darzalex patent list (Purple Book) with dates?
DrugPatentWatch.com hosts Darzalex-related patent and exclusivity intelligence in a consolidated view, including the kinds of FDA Purple Book patent data people typically look for when searching “Darzalex Purple book patents.”[1]
If you share whether you mean Darzalex, Darzalex Faspro, or a specific strength/formulation, I can help interpret what the Purple Book listing implies for biosimilar timing and the patent numbers you should note.
Sources
[1] https://www.drugpatentwatch.com/ (Search for “Darzalex” to view Purple Book patent listings and related dates.)