The Blockbusters No One Talks About
Executive Summary
Drugs like Nexium, Lipitor, Lovenox and Plavix lost patent protection years ago, but continue to generate blockbuster level sales. Here's a look at the blockbuster brands that have stood the test of (generic) time.
Just because a drug loses patent protection and faces generic competition doesn't mean it disappears in a puff of smoke from big pharma's balance sheet. Drug makers have become quite adept at managing patent expirations and preserving some revenues post-generic entry, usually by launching their own branded generics and focusing on geographic expansion in emerging markets that are largely cash-pay.
In some cases, commercial winners continue to bring in blockbuster-level sales years after losing patent protection in the US market. Those revenues may only be a fraction of what the drugs generated at their peak, and the products certainly aren't considered growth drivers, but in today's increasingly fragmented drug market – where the launch trajectory for new drugs has slowed – they pad the bottom line and remain important products. In some cases, they even remain top-sellers. Here is a look at drugs that remain blockbusters even after generics have launched in the US, based on 2017 revenues.
Crestor, $2.37bn
Rosuvastatin kept its brand exclusivity well after statin peers like Lipitor (atorvastatin) and Zocor (simvastatin) went generic, and it was a critical bandage to help AstraZeneca PLC through a challenging growth period while the company waited for its new R&D strategy to deliver. Sales of the drug peaked in 2011 at $6.22bn, but it still generated $5.07bn in 2015, the last full year before the first generics launched in the US in May 2016. (Also see "Crestor Generics To Launch After 12-Day Delay" - Pink Sheet, 20 Jul, 2016.)
Gleevec, $1.94bn
The blood cancer drug Gleevec (imatinib) remained Novartis AG's top-selling cancer drug in 2017, despite facing the first generic competition in the US and Europe in mid-2016. Sales of Gleevec had already begun to chip away prior to the generic entry as Novartis turned its attention to follow-on drug Tasigna (nilotinib), which was the company's second best-selling cancer drug in 2017.
Nexium, $1.92bn
The proton pump inhibitor esomeprazole faced the first generic competitor in the US in February 2015. It generated $3.65bn in 2014, the last full year before it faced generic competition in the US. In markets like China and Japan, use of Nexium grew in 2017. It remained one of AstraZeneca's best-selling brands, behind Symbicort (budesonide/formoterol) and Crestor.
Lipitor, $1.92bn
Pfizer Inc.'s blockbuster statin Lipitor was the number one selling drug in the world when it lost US patent protection in November 2011. It generated more than $11bn in sales in 2010, but today it remains an important blockbuster for Pfizer, outpacing sales of newer growth drivers like Xeljanz (tofacitinib) and Xtandi (enzalutamide). In fact, in 2017, sales of Lipitor grew 9% worldwide, driven by growth outside the US and Europe.
Lovenox, $1.84bn
Sanofi's all important insulin franchise Lantus (insulin glargine) continues to rule the roost, but after Lantus, Lovenox (enoxaparin) was the French pharma's second top revenue generator in 2017. That's pretty impressive given that the first generic versions of the low molecular weight heparin product launched in the US in 2010. (Also see " FDA approval of generic Lovenox sparks debate and lawsuit " - Scrip, 27 Jul, 2010.) Biosimilar copies were only approved in Europe in 2017, however. Although Lovenox is considered a complex drug, copies were approved as generics, not biosimilars, in the US.
Plavix, $1.71bn
The clot-buster Plavix (clopidogrel) faced generic competition in the US in 2012, but the drug continues to deliver for Sanofi's top line five years later – despite pressure from a slew of novel oral anticoagulants. Plavix was the leading anti-platelet in China in 2017, and most of the product sales come from China and Japan.
Zetia, $1.34bn
The first generic versions of the cholesterol-lowering medicine Zetia (ezetimibe) launched in December 2016, and Vytorin, a combination pill with simvastatin, only went generic in April 2017. The franchise remains important to Merck & Co. Inc. since the two drugs together generated $2.1bn in 2017, outpacing many other brands excluding Keytruda (pembrolizumab), Januvia/Janumet (sitagliptin) and the Gardasil vaccine. All but $476m in sales of the two drugs came from outside the US, however.
Sandostatin, $1.61bn
The first generic version of Novartis' Sandostatin (octreotide acetate) for the rare hormonal disorder acromegaly launched in the US in 2011, but the product continues to bring in rather consistent sales. The drug generated $1.61bn in 2017, roughly on par with where sales of the drug have been since 2014.
Baraclude, $1.052bn
Bristol-Myers Squibb Co.'s antiviral for hepatitis B, Baraclude (entecavir), faced generic competition in the US in 2014, but the drug always generated more sales outside the US anyway. Sales declined 12% in 2017 as international revenues experienced lower demand.