Friday, November 11, 2005

Big Pharma and the "sacred" 180 days

A new trick by Big Pharma to make life harder for generics is discussed in a very insightful Bloomberg article.

The day after a copy of GSKs' Paxil hit stores in 2003, the company introduced its own cheaper version of the $3 billion-a-year depression drug.

In doing so, Glaxo deprived Apotex Inc. of six months of market exclusivity it had expected under a U.S. law designed to nurture the generic drug industry. Apotex says the competition cost it as much as $400 million in sales.

Glaxo's tactic, since endorsed by the FDA, represents the latest bid by big pharmaceutical companies to fend off generic drugmakers, which produce $58 billion of unbranded medicines a year. The biggest makers of such treatments, Teva Pharmaceutical Industries Ltd. and Mylan Laboratories Inc., are lobbying for new laws to stop what they say is an unfair practice that may increase drug prices.

A 1984 law sponsored by U.S. Representative Henry Waxman, a California Democrat, and Senator Orrin Hatch, a Utah Republican, gave a "sacred" 180 days of market exclusivity to the first company to win approval for a copy of a treatment whose patent was expiring.

Some big drugmakers, including Pfizer J&J and Roche have built up their own generic units. Sanofi-Aventis are aiming to make small acquisitions to expand the company's generic drugs business to help defend its older products.

Novartis AG's Sandoz division, based in Holzkirchen, Germany, has gone a step further, signing agreements with other companies to market authorized generic versions of their drugs, including Bristol-Myers Squibb Co.'s Monopril heart medication.

Insiders' view: Add this to "evergreening" as another tactic which, in turn, is a symptom of Big Pharmas' Big Problem.

http://pharmagossip.blogspot.com/2005/09/big-pharmas-big-problem.html

See the full, excellent Bloomberg piece here:

http://www.bloomberg.com/apps/news?pid=10000102&sid=aqyddiV3bs6M&refer=uk

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