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SUN Pharmaceutical Industries has reached an out-of-court settlement with Novartis in the United States with regard to a patent dispute over the Swiss drug major’s Alzheimer’s drug Exelon, the Indian company said. “Under the terms of the settlement, Sun Pharma will not market generic Exelon in the US until sometime prior to the expiration of the patents covering Exelon. The specific date on which Sun may launch and the other terms of the agreement are confidential,” said Sun Pharma in a statement.

The US Food and Drug Administration (FDA) had granted final approval for Sun Pharma’s generic version of Exelon, chemically known as rivastigmine tartrate, on October 22, 2007. The approval had come after the completion of the 30-month stay triggered by Novartis’ complaint for patent infringement. However, the litigation between the two companies was still ongoing. At the time of the announcement, Sun Pharma had said that the company would “evaluate all its launch options.”
Sun Pharma, being one of the first to file an abbreviated new drug application to sell generic Exelon in the US, was eligible to share a 180-day marketing exclusivity on the drug. However, had Sun Pharma launched its generic version of Exelon before reaching an agreement with Novartis or the court’s ruling, it would have done so at risk of damages claim from the Swiss company. US-based Watson Pharma and India’s Dr Reddy’s Lab were also first-to-file on this product. The Hyderabad-based company has also received final approval to market rivastigmine tablets in the US on October 31st, 2007. Ranbaxy Laboratories is also seeking approval to market a generic version of Novartis’ drug in the US. Exelon has annual sales of about $200 million in the US.

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