Please login to the form below

Not currently logged in

Actavis mounts patent challenge on Velcade in US

Plans to launch own version of Takeda’s cancer drug

Takeda, Velcade

Generic drugmaker Actavis has filed a legal challenge against Takeda subsidiary Millennium Pharmaceuticals seeking to overturn its US patent protection on multiple myeloma and mantle cell lymphoma treatment Velcade.

Actavis' new parent company Watson Pharmaceuticals said the company had filed for approval of a generic product based on bortezomib, the active ingredient in Velcade, and had promptly been sued by Millennium for patent infringement.

Under US law, the lawsuit introduces an immediate 30-month stay on FDA approval of the generic unless Actavis can overturn patents protecting Velcade.

Millennium's defence of Velcade rests on two US patents (6,713,446 and 6,958,319) which were filed in 2005 and are both due to expire on January 5, 2022, according to court documents filed by the company.

Velcade is Millennium's biggest-selling product and had sales of around $740m in the 12 months ending October 31, 2012, according to IMS Health data.

The drug acts as a proteasome inhibitor and was first approved in the US in 2003 as an intravenous therapy and is now also available in a subcutaneous formulation.

Outside the US it is marketed by Johnson & Johnson, which said in November it recorded almost $1bn in sales for the product in the first nine months of 2012, a 16 per cent increase driven by approvals of the subcutaneous formulation in the EU and Canada.

2nd January 2013

From: Sales



Featured jobs

Subscribe to our email news alerts


Add my company

Star’s a full service resourcing house and for almost 12 years we’ve recruited the best people for pharma, medical devices...

Latest intelligence

‘Less Is More: Making Patient-Centered Digital Communication a Reality’
Letizia Affinito writes on the Gower Publishing blog....
The Seven Cs Of Cross-Functional Brand Planning
As more and more organisations have moved to cross-functional and cross-regional involvement in the development of their strategic and operational brand plans, the result has been greater engagement and alignment,...
2015/16 Pharmaceutical Titles
Browse our latest interactive Pharmaceutical and Healthcare catalogue...