2013’s biggest patent expiries

Home/Policies & Legislation | Posted 04/11/2011 post-comment0 Post your comment

2013 looks set to be another great year for generics and biosimilars, with once again some major blockbuster drugs losing patent protection.

picture 98

Just looking at just five of the best-selling drugs, US sales of more than US$14 billion will be open to competition by the generics and biosimilars industry.

Key patent expiries in the US—according to data from market research firm IMS Health— include painkiller oxycontin (oxycodone), cancer treatment Zometa (zoledronic acid) and acid reflux treatment Aciphex (rabeprazole). These patent expiries can mean a major blow to some of the largest pharmaceutical companies, whilst it will be very good news for the generics and biosimilars industry and patients.

Table 1: Key patent expiries during 2013 in the US

Brand name Generic name Treatment Company 2010 US sales ($)
Neupogen filgrastim Neutropenia Amgen 4,840,000,000*
Oxycontin oxycodone Painkiller Purdue Pharma 3,554,751,000
Epogen epoetin alfa Anaemia Amgen 3,300,000,000
Zometa zoledronic acid Cancer Novartis 2,100,000,000
Aciphex rabeprazole GERD Eisai Corporation 915,796,000

*combined sales with Neulasta (pegfilgrastim)
GERD: gastroesophageal reflux disease; neutropenia: a lack of certain white blood cells caused by cancer
Sources: IMS Market Prognosis, April 2011, Reuters, Verispan, VONA

Two of Amgen’s blockbuster biologicals are included in the list of drugs set to lose patent protection in 2013. The company’s treatment for low white blood cells, Neupogen (filgrastim), and its cancer-induced anaemia treatment, Epogen (epoetin alfa), will both lose their patent protection in the US in 2013, by which time the FDA should hopefully have sorted out practical biosimilars guidelines. These two biologicals have already lost patent protection in Europe, where biosimilars for epoetin alfa were already introduced in 2007 and for filgrastim in 2008 [1].

Once drugs lose patent protection, lower-price generics rapidly gain market share, often siphoning off as much as 90% of sales. Benefits to patients are substantial, with generics averaging about 30% of the price of the brand-name originals.

Related articles

2012’s biggest patent expiries

2011’s biggest patent expiries


1. GaBI Online - Generics and Biosimilars Initiative. Biosimilars approved in Europe [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2011 October 28]. Available from: www.gabionline.net/Biosimilars/General/Biosimilars-approved-in-Europe

Source: CNBC, Quintiles

comment icon Comments (0)
Post your comment
Related content
FDA publishes BsUFA III research roadmap
Harmonize V13F28
Home/Policies & Legislation Posted 03/03/2023
The US Biologics Competition Act and Biosimilar Red Tape Elimination Act
Home/Policies & Legislation Posted 27/01/2023
Most viewed articles
About GaBI
Home/About GaBI Posted 06/08/2009
EU guidelines for biosimilars
EMA logo 1 V13C15
Home/Guidelines Posted 08/10/2010