Abstract

The economic effects of the possible introduction of 'follow-on' protein products have been the subject of recent debate. Here, we aim to explore the economic issues surrounding this debate using three measures: total sales, product complexity and patent expiry. Our analysis shows that the sales of therapeutic protein products are concentrated in a relatively small number of branded products, which may be the most attractive targets for follow-on development. For the years 2013–2015, we estimate that products representing US$20 billion in annual sales — approximately half of all sales in 2006 — can be expected to lose patent protection.

Author affiliations

1. Michael Lanthier, Rachel Behrman and Clark Nardinelli are at the US Food and Drug Administration, 5600 Fishers Lane, Rockville, Maryland 20857, USA.
2. Disclaimer: this article was prepared by the authors in their private capacities. No official support or endorsement by the US Food and Drug Administration is intended or should be inferred.

Correspondence to: Michael Lanthier¹ Email: michael.lanthier@fda.hhs.gov

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