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Number of new drugs launched in the U.S. 2003-2015

Number of new molecular entities launched in the U.S. from 2003 to 2015

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Release date

April 2016


United States

Survey time period

2003 to 2015

Supplementary notes

New Molecular Entity (NME): A novel molecular or biologic entity or combination where at least one element is novel.
This statistic was assembled from several IMS Health reports.
NME launches in the U.S. by year of launch, regardless of timing of FDA approval.
New mechanism: First product with a new mechanism of action for its FDA approved indication.
Orphan: Drugs with one or more orphan indications approved by FDA at launch.
Existing mechanism: Subsequent products with an existing mechanism of action for an indication.

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Statistics on "Top pharmaceutical drugs"

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