Why INN’s are so Important to a Drug’s Life

Every pharmaceutical asset begins with a nonproprietary, generic name, or an International Nonproprietary Name (INN). This name could potentially be the first strategic decision you make for the commercial life of your brand.

But what exactly is an INN name and why do they exist?

Since the inception of the INN naming system in 1950 it has been providing health professionals with a way to uniquely and universally identify each pharmaceutical substance. INN’s are not only important in identifying a drug’s pharmaceutical ingredients but in providing safe prescription and dispensing of medicines to patients, and communication between health professionals worldwide. The World Health Organization (who manages & issues INN’s) issues INN’s in English, Latin, French, Russian, and Spanish, and more recently Arabic and Chinese versions are also being issued.

Here Vince Budd, Senior Vice President at Addison Whitney, speaks of the importance INN’s have on the success and lifecycle of a drug:

“Although INN’s aren’t actually considered intellectual property, developing an INN is without a doubt a strategic endeavor that many commercial, medical and regulatory officers take very seriously. First, the commercial team of an organization sees this as the first opportunity to put some sort of face or image to the asset. Although WHO would like manufactures to use trivial or fantasy letter strings when building generic names around INN stems, many approved INN’s are actually quite suggestive about the product. This helps some of the branding activities that soon follow. Also, many manufacturers must think about the life cycle of the asset and potential generic competition, which also impacts the type of INN name that is sought. The bottom line is INN development is serious business and the wrong or right name can certainly have an impact on the future success of a drug. “

According to WHO there are roughly 8,000 INN’s listed today, and that number grows by approximately 120-150 each year. Every INN must be submitted to and approved by WHO, and must follow their general principles for developing INN’s.

Source: World Health Organization