Record patent expirations roil Rx market

In 2011 and 2012, the steady surge of blockbuster pharmaceuticals falling off the patent cliff became a stampede. An astonishing number of big-selling drugs that had established and sustained branded drug makers’ profits for years fell victim to the expiration of their patent lives and market exclusivity, roiling the pharmaceutical marketplace and redefining the pricing model for many of the most widely prescribed classes of medicines.

Among the products that have lost patent protection since last fall were the world’s two biggest-selling medicines, Pfizer’s cholesterol treatment Lipitor and the anti-clotting blockbuster Plavix from Bristol-Myers Squibb and Sanofi. Other drugs losing protection this year include AstraZeneca’s antipsychotic mega-seller, Seroquel; Merck’s biggest-selling drug, the $3.4 billion asthma and allergy medication Singulair; Forest Laboratories’ anti
depressant, Lexapro; Actos, the oral Type 2 diabetes medicine from Takeda Pharmaceuticals; and Viagra, Pfizer’s erectile dysfunction treatment.

Over the next two years, the scheduled list of patent losses also will include such blockbusters as OxyContin, Nexium, Cymbalta and Celebrex. According to IMS Health, drugs generating more than $102 billion in combined annual sales will reach the end of their patent life over the next five years.

For generic drug companies, the exposure of so many of the world’s biggest-selling medicines to me-too competition for the first time has been a sales and profit bonanza. The expiring patents also herald savings for public and private health plans, not to mention patients themselves.

For branded drug makers, the patent cliff is forcing a shift in Big Pharma’s research and development efforts.

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