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Lilly wins Cymbalta exclusivity

Lilly has won a court victory that could provide US marketing exclusivity for the company's blockbuster antidepressant Cymbalta until at least the middle of 2013, according to the company

Lilly has won a court victory that could provide US marketing exclusivity for the company's blockbuster antidepressant Cymbalta (duloxetine hydrochloride) until at least the middle of 2013, according to the company.

The US District Court for the Southern District of Indiana issued an order prohibiting the defendants in a patent suit brought by Lilly from selling generic Cymbalta in the US until the compound patent for the product expires in June 2013.

Lilly filed the suit in 2008 after Wockhardt submitted an abbreviated new drug application with the US Food and Drug Administration (FDA) seeking approval of its generic Cymbalta product. Generic makers Sandoz, Impax and Cobalt also subsequently became defendants.

In the case, known as Eli Lilly and Company v Wockhardt Limited, et al, the court initially entered final judgment against Wockhardt last month and has now issued a new order requiring the defendants to notify the FDA that they are no longer seeking approval for generic Cymbalta.

"In light of the parties' stipulation to the Court's order, the litigation has been dismissed and no appeal is possible," Lilly said.

"We are very pleased with the District Court's order that effectively maintains US exclusivity for Cymbalta throughout its patented life," said Lilly general counsel Robert A Armitage.

Cymbalta was originally cleared for marketing in the US in 2004 for the treatment of diabetic peripheral neuropathy. The product received subsequent approvals for generalised anxiety disorder and maintenance treatment of major depression in 2007 and fibromyalgia in 2008. Last year, the FDA also approved Cymbalta for the treatment of chronic musculoskeletal pain.

The drug had US sales of $2.77bn in 2010, representing the lion's share of its $3.48bn in global revenues.

28th April 2011

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