Sun and Novartis settle on Gleevec

Novartis and Sun Pharma’s US subsidiary have settled litigation related to cancer drug Gleevec (imatinib mesylate) in the US, the companies announced today (May 15).

As part of the settlement agreement, Novartis will allow Sun Pharma to market a generic version of Gleevec – known as Glivec in Europe – in the US from February 1, 2016.

In 2006, Sun Pharma filed an Abbreviated New Drug Application with the US Food and Drug Administration to make and sell imatinib mesylate tablets in 100 mg and 400 mg strengths.

In June last year, it filed suit against Novartis at the US District Court of the District of New Jersey seeking declaration that its proposed generic Gleevec product does not infringe Novartis’ 6,894,051 patent, which is due to expire in 2019.

Sun Pharma said in a statement that its US subsidiary has received tentative approval from the US FDA to market imatinib mesylate tablets.

Gleevec made global sales of almost $4.7 billion in 2013. Its basic compound patent expires in the US in July 4, 2015.