Word: generic-drug
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...theory, the WTO agreement should benefit India's generic-drug companies by shielding them from strict patent laws. But many of India's drugmakers are angry about the agreement's fine print. According to D.G. Shah of the Indian Pharmaceutical Alliance, which represents the nation's largest drugmakers, the U.S. pharmaceutical lobby won key restrictions?for instance, a stipulation that generics sold under the agreement be manufactured in a different shape, dosage and packaging from the original?that make it difficult for non-U.S. companies to sell their products in poor countries and still turn a profit...
...generic-drug makers feel as if they're playing a game of 50-state Whack-a-Mole, never knowing where another amendment or rule pushed by their rivals is going to pop up. Take Illinois: last year Barr and its allies persuaded legislators to dissolve a state panel that had delayed marketing of some FDA-approved generics, but Governor George Ryan vetoed the bill. Still, all sides worked out a compromise to give immediate approval to most generics. Barr's lobbyists relaxed. Too soon, it turns out. A month ago, an amendment was quietly tacked onto a new bill...
...Claritin was stuck in the Food and Drug Administration approval pipeline longer than many drugs, it claims, with the clock ticking on its 17-year patent. Schering-Plough also says Claritin profits help fund research for new drugs. But, its opponents counter, what about Claritin patients--who pay as much as $2.66 a dose instead of the 50[cents] or less they would pay, analysts figure, if a generic version of the drug were available? If the patent expires on time, according to a University of Minnesota study funded in part by the generic-drug industry, consumers could save...
...struggle over patent extension is where Mylan has assumed the role of crusader for lower-cost drugs. Last year the company helped found a lobbying group called the Campaign for Fair Pharmaceutical Competition. The group is currently pushing to eliminate sections of the Waxman-Hatch Act, a landmark 1984 law designed to promote drug competition. One target: a provision that prevents the FDA from reviewing generic-drug applications for 30 months if the patent holder sues...
Whatever happens to Mylan, America's generic-drug industry is likely to emerge much stronger from the current turmoil. Even with delays, brand-name drugs that now account for sales of more than $40 billion a year could become available in generic form by 2008. Based on current pricing, consumers might save an additional $16 billion. And that's not too hard to swallow...