Most generic drugs take slow, contentious path to market

Legal battles delayed approval of an allergy medicine for two years.
KNIGHT RIDDER NEWSPAPERS
WASHINGTON -- For consumers and health plans waiting for a slew of cheaper generic drugs to hit the market, the tale of Flonase is worth noting.
Even though GlaxoSmithKline's patent for the allergy medicine expired in May 2004, the cheaper generic version didn't hit the market until last month.
The delay was the result of a series of aggressive administrative and legal maneuvers by GlaxoSmithKline that thwarted the speedy entrance of the generic. After a federal judge in Baltimore rebuffed Glaxo's final legal challenge on March 6, the generic version by Roxane Laboratories hit store shelves.
The generic sells for $61.99 at Walgreens.com, while Flonase costs $81.99. At CVS.com, the generic is $68.59 vs. $85.29 for Flonase.
Contentious battle
For consumers, the case shows that good things eventually come to those who wait. But it also shows that a generic drug's path to the retail market is often long and contentious. The price and market share for a brand-name drug fall dramatically when a generic alternative becomes available, so former patent holders do all they can to stave off the competition.
According to Bain & amp; Co., an international consulting firm, patents are set to expire on 75 brand-name drugs over the next two years and on an unprecedented 252 by 2014. A study by the Pharmaceutical Care Management Association released on April 18 found consumers and health plans could save more than $26.4 billion over the next five years by using cheaper generic versions of just 14 brand-name drugs scheduled to lose their patent protection between now and 2009.
But protracted legal battles are inevitable, experts say, which means consumers will face many delays before they can save on the coming wave of generic alternatives.
"Big, big fights are ahead," said Sid Wolfe, director of the Health Research Group at Public Citizen, a consumer watchdog agency. "The brand-name companies will do everything possible to prolong the day when the generic drugs become available. Buying an extra six months, two years or three years for a big-selling drug is going to mean a difference of tens or hundreds of millions of dollars."
Copycat drugs
Equally unsettling for consumers is that drug companies are again paying generic companies to drop patent challenges that could make copycat drugs available before the patents on the original drugs expire. The practice has increased because several federal court decisions reversed earlier determinations that such deals were an illegal restraint of trade.
Consumers saved about $360 million a year when a patent challenge made a generic version of the heartburn medication Prilosec available more than 15 years before the last of its patents expired.