In Western Europe, Actavis Launches A High-Profile Challenge To Pfizer's Lipitor

Pfizer's cholesterol cash cow Lipitor is seeing its first taste of competition in Spain, where generic atorvastatin tablets already have been distributed to pharmacies, generics maker Actavis announced on Oct. 1.

But the generic formulation being sold is atorvastatin magnesium, which differs slightly from Pfizer's branded Lipitor formulation - atorvastatin calcium. Because of the widely varying global patents for atorvastatin, Actavis has opted to invest in different forms of the molecule, the generics maker said.

This could give Pfizer some breathing room until its patent for atorvastatin calcium expires next year in Spain. At that time, exact replicas of the drug can be sold as lower-priced generics, which could make a much larger dent in Pfizer's sales there than recently-launched atorvastatin magnesium generics.

In Spain, where Pfizer markets Lipitor under the brand names Cardyl and Zarator , it is the top selling drug, as in the rest of the world. Annual sales of Cardyl and Zarator there are approximately €396 million ($577 million), according to IMS Health 2008 data. Global sales last year for the branded drug were $12.4 billion.

Pfizer would not comment on Lipitor's average price per day in Spain and Actavis would not release generic pricing.

But Pfizer did say, "atorvastatin magnesium is a different salt to atorvastatin calcium, the efficacy and safety of which has been demonstrated in an extensive clinical program and which Pfizer will continue to support." The drug maker also intends to "vigorously defend" intellectual property rights for Lipitor. In the U.S. and most other Western markets, the drug is not expected to face generics until 2011.

And Pfizer already has faced patent challenges for Lipitor. In June 2008, India's Ranbaxy settled a patent dispute concerning the drug with Pfizer by agreeing to delay introduction of its generic version; in turn, becoming the first to file an ANDA for generic Lipitor. This means the clock on Ranbaxy's 180-day marketing exclusivity would begin running on Nov. 30, 2011 ('The Pink Sheet,' June 23, 2008).

Generics hit store shelves in Spain

As of Oct. 1, 30 million atorvastatin magnesium tablets have been shipped for marketing in Spain, according to Actavis. These include 10 mg, 20 mg and 40 mg formulations of the drug. Though Actavis has been supplying the product to Central Eastern Europe for nearly two years, the Spanish authorities only just approved atorvastatin magnesium.

The generic is being launched and commercialized by four of Spain's largest generics pharma companies, which Actavis calls "the buyers," but Actavis declined to name names. In addition, Actavis said it will market atorvastatin magnesium under its own brand name, "shortly."

Actavis already has launched atorvastatin calcium under its own brand name in 15 European countries and in Asia, where there was no patent for the formulation.

-Carlene Olsen (c.olsen@elsevier.com)

This article is reprinted from "The Pink Sheet" DAILY –Oct 2, 2009

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