15 March 2013Americas

Mylan signs generic truce with Shionogi and Andrx

Generic drug maker Mylan has struck a deal with pharma companies Shionogi and Andrx to resolve a patent dispute over their diabetes drug Fortamet.

US company Mylan can now sell its generic version of Fortamet on August 1, 2013 or earlier “under certain conditions”, according to a short statement. The deal’s remaining details are confidential.

Japanese pharma Shionogi sells Fortamet while US company Andrx, which re-branded as Actavis in January this year, owns the patents directed to 500-mg and 1,000-mg extended-release metformin hydrochloride, both of which read on Fortamet.

In January 2010, Mylan told the companies it had applied to the US Food and Drug Administration (FDA) to market a version of Fortamet, which lowers blood glucose to improve glycemic control in adults with Type 2 diabetes. The companies sued Mylan a month later for infringing the Fortamet patents.

Shionogi and Andrx asked a Delaware court to block Mylan from manufacturing or selling the drug until the two patents protecting it expired in 2018 and 2020.

Fortamet and other licensed makers of the metformin hydrochloride extended-release tablets had US sales of about $125 million in the 12 months to September 30, 2012, according to IMS Health.

Dominick Conde, partner at Fitzpatrick, Cella, Harper & Scinto saidthe deal seems to suggest Shionogi has granted Mylan a license to launch its products but that royalty payments are unlikely to be involved.

“Typically, there is no royalty,” he said, adding that licensors may decide not to charge a fee because it feels the generic may not join the market for some time or the patents may expire soon.

“There are lots of dynamics determining when the generic comes onto the market,” he said.

He said Mylan is one of the largest US generic companies while Shionogi has a considerable presence, adding: “The drug [Fortamet] is not small but it has a presence.”

Shionogi is currently locked in litigation with drug company Lupin, which also applied to market a generic version of Fortamet. Shionogi sued Lupin, which tried to launch the drug during the litigation before a US district court issued a preliminary injunction blocking Lupin from selling its drug. In July 2012, the US Court of Appeal for the Federal Circuit vacated that injunction.

“Whether or not this shows a potential weakness in Shionogi’s case and that this was reflected in the recent settlement, it is hard to say,” Conde said.

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