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The biggest generic drug launch in history began Thursday as Barr Laboratories started shipping a generic form of the anti-depressant Prozac to stores for sale. Barr won’t specify how much the generic drug will cost, but said the price will be between 25 to 40 percent lower than Prozac’s daily cost of $2.63. That means the approximately 2 million people taking Prozac would save up to $383 annually. The drug could be offered as early as today. “I feel like an expectant father,” said Bruce Downey, Barr’s chairman and chief executive. Eli Lilly and Co.’s patent for Prozac expired Thursday, paving the way for Food and Drug Administration approval of Barr’s product, which is called fluoxetine and is available only with a prescription. Prozac generated $2.6 billion in sales for Lilly last year. It became a blockbuster because it lacks the harsh side effects of earlier depression medicines, an advancement that spurred more doctors to prescribe the medicine and helped end some of the taboo surrounding mental illness. A six-year battle over rights to Prozac ended last week when a federal judge in Indianapolis issued an order invalidating a patent that would have protected Lilly’s monopoly until December 2003. Lilly still plans to appeal but conceded it is unlikely the case will be heard. Barr’s facility in Forest, Va., has been working 10 hours a day, six days a week, since February to manufacture the 150 million capsules for the launch of fluoxetine. It typically takes Barr three weeks to fully launch a drug. Time is important because Barr has six months of market exclusivity to sell the 20 milligram capsule, which now accounts for 80 percent to 90 percent of Prozac’s revenues. Four other companies have exclusive six-month rights to other strengths or tablet forms of the generic drug. The high-profile battle over Prozac was the latest in an ongoing stream of patent lawsuits between big pharmaceutical companies and generic firms. From 2000 to 2005, patent expirations are expected to cost the pharmaceutical industry $34 billion. Generic firms accuse major pharmaceutical companies of adding insignificant patents to drugs to extend monopolies. Pharmaceutical firms counter the newer patents are the important results of ongoing research. The Federal Trade Commission is studying whether drug companies are trying to block the launch of generic drugs but is also exploring if the generic firms are colluding with the big players to benefit. Copyright 2001 Associated Press. All Rights Reserved. This material may not be published, broadcast, rewritten, or redistributed.

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