Mumbai, May 15: Sun Pharma has settled a legal dispute with Novartis over blockbuster leukemia drug Gleevec in the US. The development will pave the way for Dilip Shanghvi-promoted Sun Pharma to launch a generic version of the drug in the US in 2016.
Sun Pharma today announced that one of its subsidiaries has executed a settlement agreement with Novartis, which will result in the dismissal of the lawsuits filed in the US against it with regard to the submission of an abbreviated new drug application (ANDA) for a generic version of Gleevec, the imatinib mesylate tablets. These tablets are indicated for the treatment of chronic myeloid leukemia. ANDA is a proposal to manufacture and market a generic drug in the US.
A press statement from Sun Pharma said under the terms of the settlement agreement, its subsidiary might launch its version of the Gleevec in the US on February 1, 2016. However, the other terms of the agreement are confidential. The agreement is subject to customary regulatory approvals, it added.
Sun Pharma’s subsidiary holds a tentative approval from the US Food and Drug Administration for the ANDA. According to US data analytics firm IMS Health, Gleevec had annual sales of around $2 billion in the US.
The announcement led to the shares of Sun Pharma gaining around 2 per cent on the stock exchanges today. On the BSE, the scrip ended at Rs 621.80, a rise of 1.72 per cent over its previous close.
“This settlement validates Novartis patents while allowing Sun Pharma’s subsidiary to enter the market with its generic product,” a Novartis statement said.
However, the Swiss multinational will get a relief of around seven months before the generic version is launched. This is because the basic compound patent for Gleevec expires in the US on July 4, 2015.
The settlement comes at a time innovators are looking at various ways to maximise returns from their portfolios.
Last month, Novartis inked agreements with GlaxoSmithKline and Eli Lilly. As part of the deal, Novartis agreed to acquire GSK’s oncology products and divest its vaccines business to the latter. Novartis divested its animal health division to Eli Lilly to focus on innovative pharmaceuticals, eye care and generics.