Patents are fortresses of new drugs. The patent layout of Enbrel is quite impressive: the span from the first application in 1995 to the patent expiration in 2029 reaches 34 years. Such unrepeatable success has extended the life of Enbrel and stopped the biosimilars. This article gives a brief overview of Enbrel and Amgen’s patent protection therefor.

Enbrel(Etanercept)
As the world’s first fully human tumor necrosis factor (TNF) antagonist, Enbrel (etanercept) was first developed by Immunex and Wyeth-Ayerst and marketed in the U.S. in 1998, with the indication of rheumatoid arthritis (RA), and has now been approved 6 indications by the FDA.
Date | Indication approved by the FDA |
Nov. 2, 1998 | RA |
May 27, 1999 | Juvenile RA |
Jan. 15, 2002 | Psoriatic arthritis |
July 24, 2003 | Ankylosing spondylitis |
Apr. 30, 2004 | Moderate to severe plaque psoriasis |
Nov. 4, 2016 | Pediatric plaque psoriasis |
Amgen has obtained rights to market Enbrel in the U.S. and Canada by acquiring Immunex in 2002, which has soon become a blockbuster drug and main source of sales of Amgen. Sales of Enbrel reached USD5.014 billion in 2018, down by 7.7% compared to 2017.

Sales of Enbrel in 2008-2018 (USD100 Million, Amgen)
Sales of Enbrel in the U.S. and Canada from 2008 to 2018 showed the change of rising before declining. The decline of sales in 2017 and 2018 was mainly due to the approvals of other new drugs with same indications, such as Novartis’ new drug Cosentyx (secukinumab) for psoriasis and Pfizer’s new drug Xeljnaz (tofacitinib) for RA, and Remicade, Humira, Stelara, and Otezla also produced pressure on sales of Enbrel. And Enbrel is also faced with threats from biosimilars, in particular, there have been two biosimilars: Benepali and Erelzi marketed in the European market Pfizer is in charge of, and there have also been three biosimilars marketed in China.
Trade name | Pharmaceutical enterprise | Approval date | Approval agency | Status |
Benepali | Samsung Bioepis | Jan.13, 2016 | EMA | Marketed |
Erelzi | Sandoz | June 22, 2017 | EMA | Marketed |
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