This article appeared in the December 2011 edition of the INNsight newsletter

The Mayan calendar – it all ends in 2012

Those who confidently predict the imminent end of the world or enjoy walking around shopping centres with a placard stating, “The End of The World is Nigh” are really looking forward to next year. According to some interpretations of the Mayan calendar, 2012 is the final year with nothing after it; so if you were thinking about where to go on holiday in 2013, don’t waste your time because there won’t be any 2013.

According to Wikipedia, December 21, 2012 is regarded as the end-date of a 5,125-year-long cycle in the Mesoamerican Long Count calendar and others suggest that the 2012 date marks the end of the world or a similar catastrophe.

Being a long-established cynic, I am not entirely convinced by this. On the other hand, though, I am not Pfizer. Now there is a company that can genuinely see the end of the world approaching in 2012.

In case there is anyone who missed it, Pfizer’s exclusivity on Atorvastatin ran out in the US at the end of November leaving Watson and Ranbaxy to launch generic versions. So why has the world not already ended? Patience, all will become clear. There is still some breathing space in Europe where Pfizer managed to get a Paediatric SPC extension until May 2012.

The US situation presents a confusing, but interesting picture. The first to file and gain 180 days’ exclusivity was Ranbaxy. However, the generic company with the largest generic market share post-patent is Watson. And Teva is receiving part of Ranbaxy’s profits.

Complicated enough for you yet? How about throwing in what Pfizer is doing to try to retain some of its market share?

Let’s look at them one by one.

Ranbaxy a few weeks ago was not even sure if it would be able to launch a generic because it was still in trouble with the FDA over manufacturing irregularities. It was not until literally the last moment on the day before patent expiry that the FDA gave final approval for Ranabxy to launch.

However, Ranbaxy had been getting rather nervous about missing out on its 6-months exclusivity, and had been trying to construct some sort of alternative arrangement to have product to launch on Day 1, which is where Teva came in?

So what arrangement did they reach between themselves? Good question – and one to which no one has the answer. Or rather one to which nobody is prepared to reveal the answer. Presumably, Teva had manufactured stock under Ranbaxy label to allow Ranbaxy to launch in return for which Ranbaxy was to share its profits with Teva. Then Ranbaxy got its last minute approval, but Teva had constructed an agreement that ensured that they would receive some sort of royalty whether or not Ranbaxy used the stock that they had manufactured.

But that is just my speculation.

The early data according to the Wall Street Journal and Hindu Business Line showed that Watson really cleaned up in the first few days. They reported that Watson and Ranbaxy, together captured 14.6 per cent of US prescriptions for Atorvastatin with the majority of this going to Watson Pharma, which managed to launch an “Authorized Generic” two days ahead of Ranbaxy.

The Wall Street Journal also reports that Pfizer has offered discounts to consumers and forged deals with pharmacy-benefit managers in order to retain revenue from the Lipitor brand. The real problem for Pfizer will come in 2012 when the Ranbaxy 6 month’s exclusivity ends and every generic manufacturer from New York to New Delhi rushes to launch their own copy.

In the EU, there are already some generic atorvastins on sale in Spain that use the Calcium salt that by passes the Magnesium salt patent. However, the real problem for Pfizer will come when generic versions flood Europe after the Paediatric SPC expires in May 2012.

Pfizer will be entitled at that point to feel that the world has ended with the loss if a US$ 13bn baby. Maybe the Mayans really knew something?

Peter Wittner

peter@interpharm-consultancy.co.uk