1 May 2014Americas

Cephalon launches another Treanda action

Cephalon has filed another lawsuit to protect its chronic lymphocytic leukaemia and non-Hodgkin’s lymphoma treatment Treanda (bendamustine hydrochloride), this time against Canadian pharmaceutical company Uman Pharma.

The Teva-owned subsidiary has accused Uman of infringing two patents that cover the drug, which in 2013 generated sales of $709 million.

The first patent, 8,445,524, covers “solid forms of bendamustine hydrochloride” and expires on March 26, 2029. The second patent, 8,436,190, expires on October 26, 2030 and covers “bendamustine pharmaceutical compositions”.

Cephalon launched the action at the US District Court for the District of Delaware on April 30, in response to an Abbreviated New Drug Application (ANDA) Uman filed with the US Food and Drug Administration for approval to sell a generic version of Treanda.

In March, Cephalon sued Sun Pharma for infringing the third of Treanda’s three patents, which also covers bendamustine pharmaceutical compositions and is due to expire in 2026.

It has asked for judgment that the ‘524 and ‘190 patents are valid and enforceable, that the court find Uman’s ANDA filing an act of infringement, and for a permanent injunction keep Uman from making or selling the Treanda generic.

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