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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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  1. How much you wanna bet, that 70% of the jobs created there (after construction) are minimum wage? And Harvey is correct, the vast majority of residents in this project will drive to their jobs, and to think otherwise, is like Harvey says, a pipe dream. Someone working at a restaurant or retail store will not be able to afford living there. What ever happened to people who wanted to build buildings, paying for it themselves? Not a fan of these tax deals.

  2. Uh, no GeorgeP. The project is supposed to bring on 1,000 jobs and those people along with the people that will be living in the new residential will be driving to their jobs. The walkable stuff is a pipe dream. Besides, walkable is defined as having all daily necessities within 1/2 mile. That's not the case here. Never will be.

  3. Brad is on to something there. The merger of the Formula E and IndyCar Series would give IndyCar access to International markets and Formula E access the Indianapolis 500, not to mention some other events in the USA. Maybe after 2016 but before the new Dallara is rolled out for 2018. This give IndyCar two more seasons to run the DW12 and Formula E to get charged up, pun intended. Then shock the racing world, pun intended, but making the 101st Indianapolis 500 a stellar, groundbreaking event: The first all-electric Indy 500, and use that platform to promote the future of the sport.

  4. No, HarveyF, the exact opposite. Greater density and closeness to retail and everyday necessities reduces traffic. When one has to drive miles for necessities, all those cars are on the roads for many miles. When reasonable density is built, low rise in this case, in the middle of a thriving retail area, one has to drive far less, actually reducing the number of cars on the road.

  5. The Indy Star announced today the appointment of a new Beverage Reporter! So instead of insightful reports on Indy pro sports and Indiana college teams, you now get to read stories about the 432nd new brewery open or some obscure Hoosier winery winning a county fair blue ribbon. Yep, that's the coverage we Star readers crave. Not.

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