Number of FDA approved NMEs, 2009-2018, by size of drug owner

Published by
Matej Mikulic,
Jun 17, 2021
In 2018, the FDA approved of 28 new drugs that were owned by smaller biopharma companies. In comparison, only 14 new approved NMEs came from the top 10 pharma companies. This statistic presents the number of new molecular entities (NMEs) approved by the FDA from 2009 to 2018, by the size of drug owner or sponsors.

Number of new molecular entities (NMEs) approved by the FDA from 2009 to 2018, by size of drug owner/sponsors*

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Release date

January 2019

Region

United States

Survey time period

2009 to 2018

Supplementary notes

* Notes:
The “ Drug Sponsor/Owner ” is the company that owns the drug at time of approval or has licensed it for US or worldwide markets
“Top 10 pharma companies ”: Pharma companies ranked within the top ten worldwide by pharma sales.
“Other large biopharma companies ”: Biopharma companies ranked between 11 and 30 in terms of worldwide sales.
“Mid sized biopharma companies ”: Companies with significant sales of usually between $100 million and $1
“Smaller biopharma companies ”: Other smaller biopharma companies.

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