A New Guide for the Journey to Drug Name Approval


Clearing U.S. pharmaceutical trademarks for use and registration is more complicated and unpredictable than clearing marks in other industries. Unlike trademarks in other fields, pharmaceutical marks must be approved by the U.S. Food and Drug Administration (FDA).

Until recently, the FDA's safety and promotional review of a proposed drug name has been conducted with little official guidance using vague statutory and regulatory standards. As a result, drug companies regularly spend thousands of dollars developing and clearing drug names, only to see roughly a third of them rejected by the FDA. The rejection of a name can be particularly problematic if the drug company has already launched the product outside the United States under the rejected name.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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