Enbrel’s latest patent win? That’ll be $47bn

Amgen’s US appeal court victory yesterday, upholding Enbrel’s patents until 2029, confirms the rheumatoid arthritis drug as one of biopharma’s most prolific warhorses. Amgen stock closed up 8%, equivalent to $11.7bn of extra market cap; at a 25% profit margin this suggests that the markets see Enbrel bringing in an extra $47bn of cumulative sales between now and 2029, albeit without accounting for cost of capital. Sellside consensus compiled by EvaluatePharma sees the branded drug generating $4.7bn in the US this year, falling to $3.3bn in 2026, but the whisper numbers will of course have been different. The patent challenger, Novartis’s Sandoz division, had been rebuffed last August over two Enbrel patents Amgen had bought from Roche, and vowed to appeal. Now that this challenge has failed, it said it would consider an appeal to the US Supreme Court. Sandoz’s Erlezi is one of two Enbrel biosimilars that are approved in the US but cannot be sold because of patent litigation. In the EU, meanwhile, Erlezi and Biogen/Samsung Bioepis’s Benepali have been available for several years. If patents do hold until 2029 Enbrel will have enjoyed an incredible 31 years on the US market.

Selected biosimilar versions of Enbrel
Product Company US status EU status
Erelzi Sandoz (Novartis) Approved Marketed
Eticovo/Benepali Biogen/Samsung Approved Marketed
Etanercept Lupin/Yoshindo Phase III Filed
CHS-0214 Coherus Phase III Phase III
CT-P05 Celltrion/Pfizer Preclinical Preclinical
Pro-S02 Protheragen Preclinical Preclinical
Nepexto Mylan/Lupin Preclinical Approved
SCB-808 Clover Preclinical Preclinical
Source: EvaluatePharma.

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