Moody's: Big Pharmas face growing patent-loss threats, but some pipelines are improving

Print 04 February 2015
Tracy Staton / Fierce Pharma

For the past couple of years, the pharma industry has had something of a reprieve from patent-cliff nightmares. But according to Moody's Investors Service, some companies face new threats to their sweet dreams.

Five companies--Pfizer ($PFE), Eli Lilly ($LLY), Merck ($MRK), Amgen ($AMGN), and Novo Nordisk ($NVO)--are more threatened by patent losses than they were a couple of years ago, Moody's figures, chiefly because of potential biosimilar competition.

But that doesn't mean these companies all face the biggest challenges to their sales. AstraZeneca ($AZN), Eli Lilly and Bristol-Myers Squibb ($BMY), meanwhile, are the companies with the most exposure to patent expirations overall, with 30% to 40% of their sales at risk.

The vulnerable drugs for the latter group are familiar: AstraZeneca's Nexium and Symbicort, which lost patent protection awhile back but still boasted sizable revenues for the first 9 months of last year, and the $1 billion Synagis and $3 billion Crestor will lose their U.S. IP shields this year and next. Eli Lilly's Cymbalta, which fell off patent in 2014, still brought in more than $2 billion for that 9-month period, and Evista managed $624 million; those sales are likely to shrink further, Moody's points out, and Lilly is looking at looming expirations for Zyprexa in Japan (2015), and Cialis in the U.S. (2017).

Bristol-Myers, meanwhile, takes its biggest hit from Abilify's patent expirations, last year in the E.U. and this year in the U.S. Then there are Baraclude, Erbitux and Sustiva expirations coming in the near future.

What's changed for Pfizer, which has "moderate" exposure to patent losses and 25% to 30% of sales at risk? Celebrex went off patent earlier than expected when Moody's last industry report came out in May 2013, for one thing. Biosimilar versions of Enbrel--with $3.85 billion in sales for the first 9 months of 2014--are making their way toward market, if not at top speed. As expected, Zyvox gets generic competitors in the U.S. this year, and it accounted for $1.35 billion in first 9 months sales; the top-selling Lyrica loses its coverage in 2017.

Then there's Amgen, whose products could get biosimilar competition soon. Recently, a biosimilar version of Neupogen got a positive hearing at an FDA advisory committee meeting, and other biosim apps threaten other top Amgen products. For Novo Nordisk, the story is that some patents on NovoRapid and NovoMix have expired; though biosims aren't imminent, the drugs are technically vulnerable. According to Moody's, 20% to 25% of Amgen's sales are theoretically open to copycat competition--when it arrives, of course--while Novo's looking at exposure to 15% to 20% of sales, when biosims finally make their way to store shelves.

The good news? Several of these companies facing patent losses have managed to improve their pipeline prospects since Moody's last checked in. Those would be Eli Lilly, Amgen, Merck and AstraZeneca, the firm figures, citing peak sales estimates for near-term meds and growing diversity among their drug candidates.

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