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Loss of patent protection for Lipitor a milestone.

NEW YORK -- As 2011 was nearing a close, an era was also beginning to end for Lipitor, once Pfizer Inc.'s blockbuster cholesterol drug. On November 30 the product lost its exclusivity in the United States.

Zacks Investment Research notes that Lipitor's patent expirations could represent the biggest generic opportunity in recent times. Lipitor sales totaled about $10.7 billion in 2010, and sales for the first nine months of 2011 registered $7.6 billion. Usually when a branded drug loses exclusivity, it falls to a rapid erosion in sales with the entry of generic versions.

But Pfizer, note Zacks and other analysts, adopted an aggressive approach to minimize the impact of generics, especially during the six-month first-to-file exclusivity period (in this case granted to Ranbaxy Laboratories Ltd.) when the number of generic launches will be limited. These initiatives could help Pfizer retain significant market share. For example, the company entered into a contract with Watson Pharmaceuticals Inc. under which the latter serves as the authorized distributor of the generic version of Lipitor. The drug is being manufactured and supplied to Watson by Pfizer, which receives a share of Warson's sales of the product.

In another approach Pfizer is striving to have branded Lipitor placed on the tier 1 formulary level of health insurance plans in a move designed to enable easier patient co-pays. And in September, about three months before the end of exclusivity, the company was promoting branded Lipitor with the launch of its "Lipitor for You" program that includes assisted co-pays and targets certain patients. Eventually, says Pfizer, it may seek over-the-counter status for the drug.

Although the bulk of attention has been on the end of exclusivity for Lipitor (a statin), Kowa Pharmaceuticals America Inc. is stressing that Livalo remains under patent until 2015 and offers an option for physicians treating patients on multiple medications. Livalo (pitavasturin) was approved by the Food and Drug Administration in August 2009 and launched in June 2010 for patients with primary hyperlipidemia or mixed dyslipidemia. It is indicated as an adjunctive therapy to diet for reducing elevated total cholesterol, LDL-cholesterol, apolipoprorein B and triglycerides as well as to increase HDL-cholesterol. Kowa Pharmaceuticals America and Lilly USA LLC copromote the product in the United States.

According to Craig Sponseller, vice president of medical affairs at Kowa Pharmaceuticals America, 75% of all drugs that are processed in the body share a common metabolic pathway in the liver. Consequently, drug interactions can occur when medications sharing that pathway are taken together or with other drugs affecting the pathway.

Livalo, stresses Sponseller, reduces cholesterol but is not dependent on the pathway to be processed--thus helping to avoid drug interactions. "Even though drugs may become generic and provide an affordable and efficacious product to consumers, metabolism still matters and evaluation of complex drug regimens among patients needing lipid-modifying therapy should continue," he says.

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Title Annotation:BRANDED DRUG REPORT
Publication:Chain Drug Review
Date:Jan 2, 2012
Words:478
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