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Courts Keeping Generic Cymbalta Off Market

By R&D Editors | April 28, 2011

INDIANAPOLIS (AP) – Eli Lilly and Co. said that a federal court is blocking low-cost generic versions of Cymbalta from the market until the patents supporting the drug expire.

Eli Lilly said the order from the U.S. District Court for the Southern District of Indiana will stop generic competition for Cymbalta, Lilly’s second best-selling drug, until at least June 2013. The company said the court initially entered a judgment in its favor on March 21. As part of Wednesday’s ruling, the defendants are required to inform the Food and Drug Administration that they are not seeking approval for generic Cymbalta until the patents expire.

Eli Lilly said the litigation has been dismissed and no appeal is possible.

Cymbalta, or duloxetine, is approved to treat depression, fibromyalgia and musculoskeletal pain. The company reported $2.77 billion in U.S. sales in 2010. That was 80 percent of worldwide Cymbalta sales, which totaled $3.48 billion.

The U.S. patents on Eli Lilly’s best-selling product, the antipsychotic Zyprexa, will expire in October. The patent on its diabetes treatment Humalog will also expire in 2013. Over the next two years, the company will lose patent protection on a group of drugs that brought in 46 percent of its revenue in 2010.

Date: April 27, 2011
Source: Associated Press

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