Cephalon sues to protect cancer drug Treanda

Teva-owned subsidiary Cephalon has sued Sun Pharma, claiming the Mumbai-based firm infringed a patent protecting its Treanda (bendamustine hydrochloride) product.

According to the complaint, filed at the US District Court for the District of Delaware on March 14, Sun Pharma submitted an Abbreviated New Drug Application seeking approval from the US Food and Drug Administration (FDA) to sell a generic version of Treanda before Cephalon’s 8,609,863 patent expires.

The ‘863 patent, which covers bendamustine pharmaceutical compositions, was issued by the US Patent and Trademark Office in December 2013. It expires in 2026.

Treanda is used to treat chronic lymphocytic leukaemia and non-Hodgkin’s lymphoma. It is Teva’s biggest selling cancer therapy, with sales totalling $709 million in 2013.

In November last year, the FDA granted Treanda orphan status when it is indicated for the treatment of indolent B-cell non-Hodgkin’s lymphoma that has progressed.

Combined with the six months of paediatric exclusivity already granted, this gives Teva exclusive rights on this indication of the drug until April 2016.

Teva told LSIPR that it has no comment, while Sun said that it does not comment on ongoing patent litigation.