The Name the FDA Has to Approve: Proprietary Name Review for Drugs and Devices
By Casey Scott McKay ·
In most industries a brand name has to clear the trademark office and the market. In pharmaceuticals it has to clear a third gatekeeper whose criteria have nothing to do with either, and which rejects names at a rate that would end most branding programs. This article explains what the FDA's proprietary name review actually evaluates - the risk that a name will be confused with another product's name in a handwritten prescription, a verbal order, or a hurried reading, and the risk that the name overstates what the product does - and why a name that is a perfect trademark can fail for exactly the reasons that make it a good trademark. It covers the review timeline and how it interacts with the trademark clock, the nonproprietary name system that runs alongside, the device and biologic variants, and the backup-name strategy that every regulated naming program needs.
IP and Technology > Trademarks | Article | Published 17 October 2025 - Updated 18 May 2026 | Casey Scott McKay - marksy.us
Summary. In most industries a brand name has to clear the trademark office and the market. In pharmaceuticals it has to clear a third gatekeeper whose criteria have nothing to do with either, and which rejects names at a rate that would end most branding programs. This article explains what the FDA's proprietary name review actually evaluates — the risk that a name will be confused with another product's name in a handwritten prescription, a verbal order, or a hurried reading, and the risk that the name overstates what the product does — and why a name that is a perfect trademark can fail for exactly the reasons that make it a good trademark. It covers the review timeline and how it interacts with the trademark clock, the nonproprietary name system that runs alongside, the device and biologic variants, and the backup-name strategy that every regulated naming program needs.
Keywords: proprietary name review · dmepa · look-alike sound-alike · medication error prevention · poca phonetic orthographic analysis · fda name rejection · misbranding · promotional name implications · established name prominence · usan nonproprietary name · inn who · biologic suffix · device naming · 510(k) labeling · intent to use application timing · section 1051(b) extensions · ema name review group · dual clearance workflow · backup name strategy · post-approval name change
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