Pharmaceutical industry bracing for record patent expiries, EvaluatePharma data reveals

Thirteen US blockbusters will lose patent protection over the next two years, data from EvaluatePharma show, highlighting the challenges facing the pharmaceutical industry in the coming years.

With the reporting season in full swing it is no wonder that several big pharmaceutical company chief executives have warned of tough times ahead.

Drugs worth $15.3bn face generic competition this year
“At risk” sales to more than double to $33.2bn by 2012, biggest annual total on record
$133bn of branded drugs face patent expiry in next six years in the US alone
Pfizer to bear brunt of patent cliff with $11bn Lipitor expiry later this year

The sector is facing an unprecedented period of patent expiries when mega-blockbusters, including Lipitor, Plavix and Zyprexa, will all be exposed to cheap, generic drugs. While this is good news in terms of lowering healthcare bills, companies like Pfizer and Eli Lilly are facing the loss of hugely profitable franchises.

Top products going off-patent in 2011 and 2012

USA annual sales ($m)
Year Rank Product Company 2010 2011 2012 2013 2014 2015 2016

2011 1 Lipitor Pfizer 5,329 4,528 492 146 73 45 42
2 Zyprexa Eli Lilly 2,496 1,949 339 218 188 172 157
3 Levaquin Johnson & Johnson 1,312 734 155 62 43 30 17
4 Concerta Johnson & Johnson 929 587 306 221 189 150 111
5 Protonix Pfizer 690 279 172 96 64 41 17

2012 1 Plavix Bristol-Myers Squibb 6,154 6,315 3,014 382 113 61 28
2 Seroquel AstraZeneca 3,747 3,771 1,669 985 861 792 732
3 Singulair Merck & Co 3,224 3,356 2,178 364 125 53 21
4 Actos Takeda 3,351 3,275 1,360 582 511 462 413
5 Enbrel Amgen 3,304 3,258 3,218 3,157 3,097 3,024 2,967
6 Lexapro Forest Laboratories 2,264 2,122 188 66 50 43 39
7 Diovan Novartis 2,520 2,093 1,540 394 333 279 246
8 Viagra Pfizer 992 1,007 328 75 59 54 46
9 Provigil Cephalon 1,027 916 403 87 38 28 17
10 Geodon Pfizer 864 907 539 120 35 28 22

By 2016, medicines that generate sales of $133bn for their manufacturers in the US alone will be exposed to generics. And while this year looks bad, next year is a true annus horribilis: drugs worth $33.2bn this year will lose patent protection in 2012, more than double this year's figure.

Big pharma patent expiry risk over next 3 years (data based on FY 2010 estimates)

WW Pharma Sales in 2010 ($bn) Patent expired sales ($bn) Patent expiry within 3 years ($bn) % portfolio at risk within 3 years
Pfizer 53.6 13.8 22.7 68%
Eli Lilly 20.8 3.1 10.6 66%
Bristol-Myers Squibb 15.6 0.9 8.2 58%
Johnson & Johnson 24.3 6.5 6.3 52%
AstraZeneca 31.7 7.7 8.3 50%
Amgen 14.6 0.0 7.4 50%
Merck & Co 41.1 10.1 7.4 43%
Sanofi-Aventis 39.9 11.1 4.8 40%
Novartis 45.0 6.5 11.4 40%
GlaxoSmithKline 39.6 10.8 2.4 33%
Abbott Laboratories 19.4 3.8 1.0 25%
Roche 36.2 4.5 2.4 19%

Pfizer is bearing the brunt of these expiries with Lipitor, the cholesterol-lowering agent which generated $11bn last year. Generics will enter the US market later this year, ultimately robbing Pfizer of the world's biggest drug maker title in 2012, with Novartis the heir-apparent.

Although Eli Lilly is facing a smaller patent cliff in dollar terms, the US pharma giant is feeling similar pain. Like Pfizer, two-thirds of the company's drug sales are likely to meet generic competitors in the next three years, presenting a huge challenge which will be tough to overcome.

For more information and in-depth analysis of this data, please see:

Patent storm gathering strength

Pfizer patent cliff dwarfs peers as loss of Lipitor looms
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