NAVIGATING NONPROPRIETARY NAMING

Long before consumers ever heard of well-known drugs such as Singulair, Abilify, or Enbrel, the medical community knew them as their nonproprietary names—montelukast, aripiprazole, and etanercept.

Creating a nonproprietary name is a tremendous part in generating momentum when bringing a new drug to market, in fact, a drug cannot go to market without one, but it could without a proprietary Brand name. The nonproprietary name is what begins to form the identity of the drug as the compound nears the end of its clinical trial and will be the generic name associated with the drug beyond the proprietary patent.

Proprietary naming differs from nonproprietary naming in many ways, one of which is the composition of the name and the strategy of developing one. While a proprietary name needs to speak to the target audience and differentiate itself in the marketplace, a nonproprietary name needs to tell the scientific story of the active ingredient(s) and its chemical makeup, giving physicians the necessary information about the drug.

To articulate the story, a nonproprietary name has two-to-three components: a prefix, a stem, and occasionally an infix. Stems – which can be used throughout the name, with the most important one appear at the end – are used to describe and identify the way a drug will interact with the body. The United States Adopted Names (USAN) Council – the regulatory body that governs nonproprietary naming approval – has a database of over 300 stems that have been approved and are recognizable to healthcare professionals.

Let’s look at atorvastatin and rosuvastatin as an example, two nonproprietary names that differ only in the prefix. Both names use the same stems at the end, ‘-vastatin’ for the International Nonproprietary Names (INN) or just ‘-statin’ for USAN, which categorizes the drugs as enzyme inhibitors. This tells these drug’s chemical composition, as the drugs are Lipitor and Crestor, respectively, two well-known cholesterol drugs.

Once the nonproprietary name(s) has been crafted, it must go through USAN to gain approval before being used in the market (similar to getting the FDA to approve proprietary Brand names), where companies are able to submit three-to-five names for review. The USAN Council meets on a rolling basis to review submissions and can take between three to five months before accepting submissions or rejecting them and providing feedback. This makes timing critical in the process. Ideally, nonproprietary names should be submitted while the drug is in Phase II of the clinical trial. This will also leave enough time to submit back-up names, should the first batch get rejected, an aspect of submission that is often overlooked.

While a USAN approval will qualify a nonproprietary name for the American market, approval from the INN under the World Health Organization (WHO) is what will approve the name internationally. USAN helps companies in getting INN approval as well. Once they have approved a name, the Council will pass the names along to INN, which meets only twice a year and can take another 13 to 16 months to reach a consensus, again illustrating how critical timing can be as a factor as a rejection could delay progress for a significant amount of time.

Creating a nonproprietary name is no small feat and, because of the stem regulations and submission processes, a firm understanding of how all the pieces fit together is vital. While the nonproprietary name may end up being an identifier most commonly used within the medical community, it is important in establishing the trajectory of the drug’s identity among other audiences and will continue to be a part of the drug’s Brand story moving forward.