As innovaters prep for patent cliff, generics prosper from patent losses

A whole slew of drugs will lose patent protection this year, opening up opportunities for generic drug makers to market their own versions. Most notable among these is Pfizer’s cholesterol-
lowering drug Lipitor (atorvastatin), the world’s top-selling drug, with U.S. sales of $7 billion during the 12 months ended September 2010, according to IMS Health.


Other important drugs facing generic competition over the next few years include the cardiovascular drug Plavix (clopidogrel) by Sanofi-Aventis and Bristol-Myers Squibb, and Eli Lilly schizophrenia and bipolar disorder drug Zyprexa (olanzapine), which had annual sales of $5.8 billion and $2.8 billion during the 12 months ended September 2010, respectively. Though Sanofi and BMS recently scored a victory when the Food and Drug Administration extended the pediatric exclusivity period for Plavix until 2012, the party will soon be over, or it will at least wind down a bit.


The year 2014 marks the patent cliff, at which point most of the top-selling drugs will have lost patent protection. Generic drug companies have grown significantly on the strength of generic versions of blockbuster drugs, but after 180 days of market exclusivity in which to compete with the branded version, a molecule becomes fair game for any generic manufacturer, thus commoditizing it so much that the innovator sometimes has to pull the branded version from the market.


While branded and generic drug companies alike have sought refuge in biologics and follow-on biologics, the market for drugs to treat such widespread conditions as cardiovascular disease won’t necessarily go dry. According to a recent report by the Pharmaceutical Research and Manufacturers of America, 299 drugs are in development for treating cardiovascular disease, with 16 applications filed with the FDA seeking approvals for new drugs or new uses for existing drugs. Perhaps amid those 299 drugs lie some blockbusters to be.