Thirteen blockbuster prescription drugs in the United States will lose patent protection over the next two years, highlighting the financial challenges looming over the pharmaceutical industry, according to data from EvaluatePharma.


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Researcher sizes up impact of drug 'patent cliff'

February 3rd, 2011

LONDON – Thirteen blockbuster prescription drugs in the United States will lose patent protection over the next two years, highlighting the financial challenges looming over the pharmaceutical industry, according to data from EvaluatePharma.

The London-based pharmaceutical research firm said Wednesday that drugs worth $15.3 billion face generic drug competition this year in the U.S. market, and so-called "at risk" sales stand to more than double to $33.2 billion by 2012 — the biggest annual total on record.

In the United States alone, $133 billion of branded drugs face patent expiry over the next six years, EvaluatePharma reported, noting that Pfizer will take the largest hit from the "patent cliff" later this year with the loss of patent protection for its cholesterol medication Lipitor.

"The sector is facing an unprecedented period of patent expiries when mega-blockbusters —  including Lipitor, Plavix and Zyprexa — will all be exposed to cheap, generic drugs," EvaluatePharma stated. "While this is good news in terms of lowering health care bills, companies like Pfizer and Eli Lilly are facing the loss of hugely profitable franchises."

Top branded pharmaceuticals due to go off-patent in 2011 include Pfizer's Lipitor (2010 U.S. sales of $5.33 billion), Eli Lilly's Zyprexa (2010 U.S. sales of $2.50 billion), Johnson & Johnson's Levaquin (2010 U.S. sales of $1.31 billion) and Concerta (2010 U.S. sales of $929 million), and Pfizer's Protonix (2010 U.S. sales of $690 million), according to research by EvaluatePharma.

The leading five drugs slated to lose patent protection in 2012, the researcher said, are Bristol-Myers Squibb's Plavix (2010 U.S. sales of $6.15 billion), AstraZeneca's Seroquel (2010 U.S. sales of $3.75 billion), Merck's Singulair (2010 U.S. sales of $3.22 billion), Takeda's Actos (2010 U.S. sales of $3.34 billion) and Amgen's Enbrel (2010 U.S. sales of $3.30 billion).

Over the next three years, six Big Pharma companies will have at least half of their portfolio at risk due to patent expirations, based on fiscal 2010 estimates, EvaluatePharma said. They include Pfizer (68% of portfolio at risk within next three years), Eli Lilly (66% at risk), Bristol-Myers Squibb (58% at risk), Johnson & Johnson (52% at risk), AstraZeneca (50% at risk) and Amgen (50% at risk).

"Pfizer is bearing the brunt of these expiries with Lipitor, the cholesterol-lowering agent which generated $11 billion [in total sales] last year. Generics will enter the U.S. market later this year, ultimately robbing Pfizer of the world's biggest drug maker title in 2012, with Novartis the heir apparent," EvaluatePharma said. "Although Eli Lilly is facing a smaller patent cliff in dollar terms, the U.S. pharma giant is feeling similar pain. Like Pfizer, two-thirds of the company's drug sales are likely to meet generic competitors in the next three years, presenting a huge challenge which will be tough to overcome."
 

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