Opinion: Parachuting off the Patent Cliff

As the United States edges ever closer to the dreaded fiscal cliff, the pharmaceutical industry approaches a precipice of its own.

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WIKIMEDIA, WING-CHI POONDrugmakers are currently in survival mode as patents on existing blockbuster drugs expire, forcing Big Pharma companies to parachute off the proverbial patent cliff. This legal escarpment means the end of patent protection on various blockbuster drug products, opening the market to generic substitutes. What makes the current timing so interesting is the large quantity of hugely profitable drugs whose patents have expired in the last few years or will expire soon. Over the past few years, the patents have expired for Enbrel, Zyprexa, Plavix, Arimidex, and Lipitor. This year, Seroquel, Actos, Singulair, and Lexapro have gone or will go off patent. In the coming 2 years, drugs including Oxycontin, Cymbalta, and Nexium will expire. With the loss of patent protection on so many blockbuster drugs, Big Pharma’s financial outlook is unsteady.

With the end of market exclusivity, drug companies are faced with billion dollar revenue losses. It has been estimated that drug products earning their makers a combined $170 billion per year will go off patent by 2015. Identification of new blockbuster drugs has been slow within the industry, particularly with the growing costs of research and development coupled with the broader worldwide economic downturn and healthcare reform. This has raised questions as to how and whether Big Pharma could maintain a stake in the marketplace. The impact of the patent cliff may be widespread, but Big Pharma has been taking positive steps to adapt to the changes.

To successfully navigate the changing times, diversification is the key. Research and development efforts have been refocused outward, ...

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