Table 2.
Basic patent and other exclusivity protections on selected therapeutic monoclonal antibodies.10,31-37
| Brand name | Active substance | Regulatory market exclusivity | Basic patent | SPC* | SPC extension | End of protection* | Protected years since approval |
|---|---|---|---|---|---|---|---|
| Humira® | adalimumab | 08.09.2003–08.09.2013 | EP0929578 (10.02.1997–10.02.2017) | 10.02.2017 to 16.04.2018 | + 6 m (ped) | Oct 16, 2018 | 15 years |
| Avastin® | bevacizumab | 12.01.2005–12.01.2015 | EP0666868 (28.10.1992–28.10.2012) | On EP0451216: 28.12.2009 to 28.12.2014 | + 6 m (ped) on EP0451216 (28.12.2014) | Jan 23, 2022‡ | 17 years |
| On EP1325932: 03.04.2018 to 16.12.2019 | + 6 m (ped) on EP1325932 (16.06.2020) | ||||||
| Enbrel® | etanercept | 02.02.2000–02.02.2010 | EP0939121 (31.08.1990–31.08.2010) | 31.08.2010 to 31.01.2015 | + 6 m (ped) | Aug 1, 2015 | 15,5 years |
| Remicade® | infliximab | 13.08.1999–13.08.2009 | EP0610201 (18.03.1992–18.03.2012) | 18.03.2012 to 24.08.2014 (UK), 13.08.2014 (Germany, France) | + 6 m (ped) | Feb 24, 2015 (UK), Feb 13, 2015 (Germany, France) | 15,5 years |
| MabThera® | rituximab | 02.06.1998–02.06.2008 | EP0669836 (12.11.1993–12.11.2013) | / | / | Nov 12, 2013 | 15,5 years |
| Herceptin® | trastuzumab | 28.08.2000–28.08.2010 | EP0590058 (15.06.1992–15.06.2012) | 15.06.2012 to 29.07.2014 | / | July 29, 2014 | 14 years |
| On EP0451216: 28.12.2009–29.07.2014 | |||||||
| Erbitux® | cetuximab | 29.06.2004–29.06.2014 | EP0359282 (15.09.1989–15.09.2009) | On EP0667165: 15.09.2009 to 14.09.2014 | / | Sept 14, 2014 | 10 years |
| Soliris® (Orphan drug) | eculizumab | PNH: 20.06.2007–20.06.2017+ 2 years as pediatric reward (2019) | EP0758904 (01.05.1995–01.05.2015) | 01.05.2015 to 01.05.2020 | / | May 1, 2020 | 13 years |
| aHUS: 29.11.2011–29.11.2021+ 2 years as pediatric reward (2023) | |||||||
| MG: 17.08.2017–17.08.2027 | |||||||
| Lucentis® | ranibizumab | 22.01.2007–22.01.2017 | EP0940468 (15.06.1992-withdrawn) | On EP0451216: 28.12.2009 to 27.12.2014 | / | Jan 24, 2022 | 15 years |
| On EP0973804: 03.04.2018 to 24.01.2022 |
SPC: supplementary protection certificate; ped: extension for results of pediatric plan; PNH: paroxysmal nocturnal hemoglobinuria; aHUS: atypical hemolytic uremic syndrome; MG: myasthenia gravis
* The exact date might differ with one day in the different European Member States, depending on calculations by national patent offices.
‡This date is mentioned in many (web) articles as the date when biosimilars for bevacizumab may enter the market, and is seemingly linked to the end of the SPC protection on ranibizumab, an antibody fragment derived from the same murine monoclonal antibody as bevacizumab.