Eli Lilly ($LLY) can enjoy competition-free Cymbalta sales for 6 months longer. Thanks to FDA's pediatric-exclusivity program, the blockbuster antidepressant won't face generic rivals until next December, rather than June, when its patent expires. The extension comes as a reward for testing Cymbalta in children and adolescents.
That's a big deal for Lilly, which reaped $3.2 billion from Cymbalta sales in the U.S. last year. The prospect of an extra $1.5 billion in sales is well worth the cost of studying Cymbalta in children. Or more, even: for the first quarter of 2012, U.S. sales rose by 24% to $857.6 million, partly because of higher prices. The company's patent-cliff losses are among the worst in pharma, so every billion is a big help.
What Lilly won't get from its two pediatric studies is approval to market Cymbalta for use in kids, the company says. The studies found that Cymbalta didn't beat placebo at treating depression in young people. (Neither did Lilly's old-standby antidepressant Prozac, also tested in the studies.)
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