Some $100 billion worth of name-brand drugs will lose patent exclusivity in the next five years, with $21 billion going off-patent in 2006, according to Andrew Forman, analyst for WR Hambrecht & Co. The biggest-selling drug losing exclusivity in 2006 is Zocor, the cholesterol-reducing blockbuster from Merck & Co. that made $5.2 billion in 2004 sales.
The FDA are reviewing generic drug applications at an increasing rate:
364 in 2003
474 in 2004
771 in 2005 (anticipated).
Conversely, of the seventy-eight drugs approved by the FDA in 2002, only seventeen contained new active ingredients, and only seven of these were classified by the FDA as improvements over older drugs. The other seventy-one drugs approved that year were variations of old drugs or deemed no better than drugs already on the market. In other words, they were me-too drugs. Seven of seventy-eight is not much of a yield. Furthermore, of those seven, not one came from a major US drug company.
So, at the same time as old bockbusters come off patent, (and especially now, post-Vioxx) new potential blockbusters are becoming as rare as rocking horse droppings! Big Pharmas Research is both constipated and increasingly expensive. The irony is that for every $1 spent on R&D they spend $2 on sales and marketing. The US has 90,000 drug reps!
Will Big Pharma survive?
Yes, if it adapts. A case of Darwinism in action?
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