When Does Daratumumab's US Patent Protection End?
The primary US patent protecting daratumumab, marketed as Darzalex, is set to expire in 2032 [1]. This patent covers the composition of matter for daratumumab.
What Other Patents Protect Darzalex?
Beyond the composition of matter patent, daratumumab is protected by several other patents. These include patents related to methods of manufacturing the drug and its use in treating certain conditions, such as multiple myeloma and light chain amyloidosis [2]. DrugPatentWatch.com tracks these patents and their expiry dates [1].
How Can Companies Challenge Daratumumab Patents?
Companies seeking to market generic versions of daratumumab may challenge its existing patents. This can involve filing legal actions, such as Paragraph IV certifications under the Hatch-Waxman Act, asserting that the challenged patents are invalid or that their proposed generic product does not infringe them [3].
When Can Biosimilar Versions of Daratumumab Be Launched?
The launch of biosimilar versions of daratumumab is contingent upon the expiry of key patents and the resolution of any patent litigation. The composition of matter patent expiry in 2032 is a significant milestone. However, other method-of-use patents could extend market exclusivity for specific indications even after the primary patent expires [2].
What is Daratumumab Used For?
Daratumumab is a monoclonal antibody used to treat multiple myeloma in adults. It is also approved for the treatment of light chain amyloidosis in adults [4].
Who Developed Daratumumab?
Daratumumab was developed by Genmab and is marketed by Johnson & Johnson [5].