Teetering on the edge of the patent cliff

In November last year, the patent expired on Pfizer’s cholesterol-lowering medication Lipitor (atorvastatin), the world’s best-selling drug with annual sales of almost US$11 billion. According to data from EvaluatePharma, over the next five years, blockbuster pharmaceuticals generating over $267 billion in revenues each year will lose their patent protection. These include the anti-clotting drug Plavix ($6.7 billion in sales per annum) produced by Bristol-Myers Squibb, and AstraZeneca’s Seroquel ($5.3 billion) used to treat schizophrenia and bipolar disorder.

That so many prescription medications are falling off the so-called ‘patent cliff’ is good news for both patients and health care providers – private and public. Name-brand drugs typically cost 20 to 80 percent more than their generic counterparts, meaning that massive savings could be made. As a result of patent expiration, during the past five years the USA spent $50 billion less on Medicare than official federal projections, says Michael Kleinrock of market researchers, IMS Health.

Manufacturers of generic drugs also stand to be benefit. India-based Ranbaxy Laboratories Limited has already secured approval from the Food and Drug Administration, the US consumer protection agency, to sell a generic version of Lipitor in the US market. Generics currently represent between 70 and 80 percent of the pharmaceuticals market and their importance is expected to grow in years to come. India annually exports medicines worth $11 billion, fulfilling much of the demand from aid agencies operating in the developing world.

Large pharmaceutical companies warn that the loss of revenues from exclusive sales rights will affect their ability to raise money for the research and development of new products and therapies, which would have detrimental effects for patients.

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