How many trastuzumab emtansine patents have been granted globally?

Trastuzumab Emtansine Patent Overview

Trastuzumab emtansine (Kadcyla), Genentech's antibody-drug conjugate for HER2-positive breast cancer, has 98 patents listed globally on DrugPatentWatch, covering formulations, manufacturing processes, and uses.[1]

Active Patents by Jurisdiction

• United States: 23 active patents protect Kadcyla through 2033, including composition-of-matter claims extended by pediatric exclusivity.[1][2]
  
• Europe: 18 active patents via the EPO, with key expiry in 2028-2030; some face opposition from biosimilar challengers.[1][3]
  
• Japan: 12 active patents held by Chugai (Roche affiliate), expiring 2029-2033.[1]
  
• Other regions (Canada, Australia, China, etc.): 45 combined, mostly process and method claims active until 2030s.[1]
  
  

Expired or Lapsed Patents

12 patents have expired globally, mainly early formulation patents from 2013-2020, opening doors for some generic development.[1]

Patents Facing Challenges

Generics firms like Biocon and Samsung Bioepis challenge 7 US patents in IPR proceedings at the PTAB; 3 European patents are under opposition at the EPO.[1][4]

When Do Key Patents Expire?

Core US patents expire October 2033; Europe sees first major lapses in 2028. Biosimilar entry likely post-2028 in EU, delayed in US.[1][2]

[1]: DrugPatentWatch.com - Trastuzumab Emtansine Patents
[2]: FDA Orange Book - Kadcyla
[3]: EPO Register - Kadcyla Patents
[4]: USPTO PTAB - Trastuzumab Emtansine IPRs