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FDA approves first generic versions of Lilly's Cymbalta

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The Food and Drug Administration has approved the first generic versions of the blockbuster antidepressant Cymbalta, offering lower-cost access to one of the most widely prescribed treatments for depression, anxiety and other disorders.

Cymbalta is Eli Lilly and Co. Inc.'s best-selling drug and posted 2012 sales of $4.7 billion, making it the fifth-highest selling medication in the world. The drug's patent expired Wednesday, clearing the way for the launch of cheaper versions of the drug from generic drugmakers. Generic drugs often sell for a fraction of the price of the original branded product.

Besides depression, Cymbalta is also prescribed to treat generalized anxiety disorder, diabetic nerve pain, fibromyalgia and forms of chronic pain.

The FDA said it approved six generic versions of the pill from drugmakers including Dr. Reddy's Laboratories Ltd., Sun Pharma Global and Teva Pharmaceuticals.

The loss of Cymbalta is the latest in a series of patent expirations that have battered Indianapolis-based Lilly's balance sheet in recent years. Revenue has been under pressure since 2011, when the company's all-time best selling drug, the antipsychotic Zyprexa, lost U.S. patent protection. That drug, approved to treat schizophrenia and bipolar disorder, once had global sales of more than $5 billion per year.

Earlier this year the company also lost U.S. patent protection for its best-selling insulin injection for diabetics, Humalog, which had 2012 sales of $2.4 billion.

Lilly has said it will counter the revenue loss from the patent expirations by developing new drugs, cutting costs and depending on sales in foreign markets and developing countries.

Lilly stock fell 51 cents Wednesday, to $49.98 per share.

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  • once again, they lose 25-30 percent of revenue stream
    It seems that eventually, due to cost cutting (jobs) in Indiana, Lilly will lose momentum for new development. But there is the alternative, ship the jobs to China, India where there are adequate drug development companies and where nearly 3 Billion customers are located. Shipping development and manufacturing offshore would allow much cheaper labor at all levels and access directly to the growing markets. The net of it is, with this product going off patent and 5 Billion in revenue off the table or 25 percent or more of revenue. With loss of Zyprexa, Humalog/Synthetic Insulin, and this product, hard to fill the gap without cutting positions, budgets, outsourcing (H1B's in IT to Tata from India), etc. The ever shrinking Indiana workforce will continue. They sold the Tippecanoe facility to a German Company, Greenfield to Covance, and Clinton facility is questionable. Only manufacturing left is in Indianpolis where the Technology Center is located. They leased/sold their large facility to Rolls Royce which they build in the early 2000's and consolidated to the Corporate Center. Seems they are consolidating to Indianapolis and then shrinking the Indy workforce through attrition, retirements, and offshoring, outsourcing to Indian IT companies. This will continue unless they have another blockbuster which is possible, but not in the near future until later near 2020.

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