Just how much of an impact the loss of patent protection can have on a blockbuster drug became clear earlier this year.
In April, Thomson Reuters Pharma reported that Abbott Labs’ Humira (adalimumab), an advanced specialty medicine to treat arthritis, would replace Pfizer’s perennial powerhouse, the cholesterol drug Lipitor (atorvastatin) as the world’s top-selling drug in 2012. What’s more, Reuters noted in its analysis, Lipitor and the drug that briefly replaced it as the world’s biggest seller, Bristol-Myers Squibb’s and Sanofi’s blood-thinning drug Plavix (clopidogrel), might not even make the top 10 list.
It’s stark confirmation of the role price can play in the pharmaceutical market — and of the marketing power generic competitors can have when given access to a massive-selling drug that has lost its market exclusivity. Bristol-Myers reported that sales of Plavix plunged 60% in its fiscal second quarter 2012, following loss of patent protection, to $741 million.
But Humira’s rapid rise also reflects another powerful trend in pharmaceutical research and development: the growth of specialty drugs and the accelerating shift by drug makers away from traditional modes of small-molecule drug development to treat whole classes of illness, such as cardiovascular and respiratory disease. Increasingly, manufacturers are focusing their research and development on specialty and biotech research into more specialized medicines aimed at much smaller segments of the patient population, and banking on the higher premiums charged for those targeted medicines to offset the reduction in the number of blockbuster drugs taken by millions of patients.