Actavis has launched a generic version, through intermediaries, of Pfizer’s blockbuster cholesterol drug Lipitor in Spain.

The Icelandic drugmaker says that its third-party sales division, Medis, has delivered 30 million tablets of atorvastatin magnesium, as opposed to atorvastatin calcium, the ingredient in Lipitor, to four of Spain's largest generic pharmaceutical companies. Distribution to Spanish pharmacies has already commenced, it noted.

Actavis said that atorvastatin tablets are subject to “widely varying patent situations around the world, which is why Medis has invested significantly in different forms of the molecule”. In Spain, the firm argues that “the patent landscape is different to other western European markets, and its version has already been approved by Spanish regulators. Actavis will launch its own brandname product in Spain shortly.

Pfizer’s atorvastatin calcium product is patented until 2010 and is sold in Spain as Cardyl and Zarator. Sales in Spain reached 396 million euros last year and is the country’s top-selling drug.

Actavis has already launched its generic version of Lipitor in Iceland and in 14 other countries where there was no patent. The Reykjavik-based group added that Medis is currently promoting three different dossiers for atorvastatin and “has been supplying a product suitable for central eastern Europe for close to two years”.

Pfizer has been defending its Lipitor patents across the world for the last few years but in June 2008 it reached a deal with Ranbaxy Laboratories which meant that the Indian drugmaker would hold off launching its generic version of the world’s best-selling drug until the end of November 2011. For the moment the New York-based behemoth has limited itself to saying that atorvastatin magnesium is a different salt to atorvastatin calcium, “the efficacy and safety of which has been demonstrated in an extensive clinical programme and which Pfizer will continue to support”.

However Pfizer did add that it “intends to vigorously defend our intellectual property”.