USA - Generics Hit Shelves After Pfizer’s Patent For Cholesterol Drug Lipitor Expires

Pfizer’s Lipitor patent expired November 30

Watson Pharmaceuticals first company authorized to sell generic version of Lipitor

Pfizer could lose $6 billion in revenue in 2012, hopes to make $4 billion from new drugs

Pfizer Inc’s U.S. patent on the cholesterol drug Lipitor expired November 30, allowing competitors to begin manufacturing and distributing generic versions of the drug. Two companies have already expressed interested in doing so.

Watson Pharmaceuticals has struck a deal with Pfizer to market and distribute a generic version of Lipitor, which is manufactured by Pfizer. Pfizer will receive a portion of the net sales, and Watson began shipping its drug on November 30. The agreement expires in November 2016.

Indian pharmaceutical company Ranbaxy Laboratories Ltd. also will be manufacturing a generic Lipitor in its New Jersey plant.

Currently, the only companies that have been authorized to make a generic Lipitor for the next six months are Pfizer, Watson Pharmaceuticals and Ranbaxy Laboratories. After that time, it is expected more companies will be authorized, and the price of the drug will drop significantly.

Pfizer’s patent in Canada, Mexico, Brazil and Spain expired in 2010. In France, generic Lipitor will be manufactured and distributed by Sanofi-Aventis, beginning in May 2012.

What’s Next for Pfizer?

Lipitor is the best-selling drug of all time and has resulted in $100 billion in revenue for Pfizer since it was introduced in 1997. In the United States alone, nine million people take Lipitor.

In 2010, global sales of Lipitor were $10 billion. Financial analysts predict sales for 2012 could be just under $4 billion.

Pfizer’s total sales for 2010 were $67 billion. The company predicts its sales for 2012 will be $63 billion. Nearly one-fifth of the company’s revenue is from Lipitor. In addition, Pfizer plans to sell its nutritional and animal health businesses, which will result in a loss of about $5.5 billion in revenue annually.

In an effort to compete against other drug manufacturers, Pfizer plans to work with health insurance providers and pharmacies to offer new Lipitor patients a 180-day period where they would receive the drug at or near the price of generic.

The average Lipitor prescription costs $120 a month. During December that price is expected to drop 30%.

Pfizer’s president of specialty care and oncology Geno Germano told Bloomberg BusinessWeek: “We’re not going to be a one-product company. We’re poised to deliver significant new pipeline assets in the coming year, and in coming years.”

Pfizer is hopeful it will make $4 billion in revenue by 2014 with the sale of four new drugs: Prevnar, Eliquis, Tofacitinib and Xalkori. Eliquis, a blood thinner, and Tofacitinib, a rheumatoid arthritis drug, have not yet been approved by the Federal Drug Administration.

The company may turn to developing countries to replace revenue, with China alone expected to deliver 1 billion new customers.

Key Statistics – Global Cholesterol Treatment Market (source: Global Industry Analysts)

By 2015, it is predicted cholesterol exams and other cardiovascular testing will total 2.3 billion units globally.

The largest region for cholesterol and other cardiovascular testing is Asia-Pacific; in Japan, the market is predicted to be 6.7% between now and 2015.

The fastest growing test in the global market is the lipid panel test/complete lipid profile. The other major test is the HDL cholesterol test.

The second fastest growing market for cholesterol exams and other cardiovascular tests is predicted to be Apolipoprotein B with 7.2% of the market.

Melina Druga

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