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Patent Cliff II: Nightmare on blockbuster street returns in 2015

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Today's look at AstraZeneca's ($AZN) bleak 2012 numbers highlights the market-crunching wallop many of the world's biggest pharma companies have suffered as megablockbusters like Plavix and Singulair have gone off patent. But a new analysis from EP Vantage, the editorial arm of EvaluatePharma, concludes that the industry giants will have almost as much at stake again when the 2015 patent cliff arrives. And some may have to make bold moves to cushion themselves against the multibillion-dollar blow, with a few considering a split along the same lines as Abbott ($ABT)/AbbVie ($ABV).

Significantly, though, there will be some important differences that will help soften the blow considerably in 2015. Most notably many of the big blockbusters coming off patent are biologics, and with biosimilars' future still uncertain they won't be picked apart instantaneously the way small molecules are. Analysts are also enthusiastic about the rising rate of new drug approvals, indicating that the long R&D drought may be over, with more new products on the way. Those trends explain why analysts are telling EP Vantage that worldwide sales will grow, jumping 8% from $753.1 billion in 2014 to $786.5 billion in 2015.

"Initially the figures do look depressing, but I don't think people should be running for the hills just yet," says EP Vantage Editor Lisa Urquhart. "The efforts the industry has put in to change business models, which have included investing more in niche busters, mean this time round things might not be as bad. Also a number of the drugs facing patent expiries are biologics, including Rituxan and Neulasta, so the actual sales erosion should not be as high as that for the small molecule expiries we saw in 2012."

Like many other analysts, Urquhart is quite emphatic that the megamerger era is over. But you can expect more bolt-ons as companies scout for specific assets that can be pushed to an approval. A few big company splits along the lines that Pfizer has been considering may also be on the way. 

"J&J may be a good example of a company that has a lot of components," says Urquhart, which may be more effective in biopharma as a "smaller, more focused, agile unit."

Drugs earning $35.1 billion lost patent protection last year. In 2015 the tally comes almost as close: $33.5 billion.  Here's a look at the top 10: Sanofi's ($SNY) Lantus, with 2014 U.S. sales projected at $4.8 billion; Abilify from Otsuka, $3.9 billion; Roche's ($RHHBY) Rituxan, $3.6 billion; Amgen's ($AMGN) Neulasta, $3.44 billion; Teva's ($TEVA) Copaxone, $2.7 billion; Novartis' ($NVS) Gleevec, $2 billion; Forest's ($FRX) Namenda, $1.6 billion; GlaxoSmithKline's ($GSK) Lovaza, $882 million; Teva's Treanda, $746 million; Boehringer Ingelheim's Combivent, $694 million. Add another $9.2 billion and you have $33.5 billion.

- here's EP Vantage report

Special Reports: Top U.S. Generic Blockbusters | Top 15 drug patent losses for 2013

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