Pharma Cos Face "Patent Cliff" as Protection Expires

Ten Blockbusters will End in Two Years –

An article in Daily Finance says that patents that are expiring on many top-selling drugs will cause pharmaceutical company sales to drop by as much as $30 billion in  2011 and 2012 and will have continued impact.

The Ten Biggest Selling Drugs that are About to Lose their Patents notes that an estimated $250 billion in sales between now and 2015 are at risk.

This may be good news for some consumers, who will pay less, but bad for companies like Pfizer, whose top-selling Lipitor peaked out at $12.9 billion in 2006, representing  27% of its total sales.

The situation would be less of a problem for the pharma industry if there were more patentable drugs in company R&D  piplines. Generic companies are expected to benefit only until about 2015, when there will be fewer blockbusters coming off of patent for them to replicate.

The five biggest selling drugs set to lose patent protection this year and next:

Patent Expiring in 2011 Condition Company 2010 U.S. Sales
Lipitor Cholesterol Pfizer $5,329,000,000
Zyprexa Antipsychotic Eli Lily $2,496,000,000
Levaquin Antibiotics Johnson & Johnson $1,312,000,000
Concerta ADHD/ADD Johnson & Johnson $929,000,000
Protonix Antacid Pfizer $690,000,000
Patent Expiring in 2012 Condition Company 2010 U.S. Sales
Plavix Anti-platelet Bristol-Myers Squibb/ Sanofi-Aventis $6,154,000,000
Seroquel Antipsychotic AstraZeneca $3,747,000,000
Singulair Asthma Merck $3,224,000,000
Actos Type 2 diabetes Takeda $3,351,000,000
Enbrel arthritis Amgen $3,304,000,000

In an eye on the future, since 2009 Pfizer paid $68b for Wyeth, Merck paid $41b for Schering-Plough, Roche paid $46b for Genentech, and Sanofi-Aventis paid $20b for Genzyme.

Future emphasis for both branded and generic drug companies is likely to be on biologics and follow-on biolgoics or biosimilars, which are created from processes sometimes using living entities, such as cells and tissues, as opposed to chemical compounds. Until recently most drugs have been derived from chemical compounds.

The Patient Protection and Affordable Care Act recently awarded biologics a 12-year limit on patent protection, providing some clarity with regard to IP.

Charts: IBIS World and Daily Finance


  1. Perhaps the impending “patent cliff” will help refocus pharma. As a New York Times article points out, rather than inventing new ailments so that they can invent new drugs to sell to more people, maybe now the pharmaceutical companies will have more of an incentive to streamline their operations and create drugs for people who really need them. If cures for cancer and other such serious ailments result from it, then I gladly welcome the patent cliff.


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