Know the Pharma Basics: INN and USAN

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An International Nonproprietary Name (INN) is an official generic and nonproprietary name given to a pharmaceutical drug or active ingredient. INN identifies pharmaceutical substances or active pharmaceutical ingredients. Each INN is a unique name that is globally recognized and is public property. A nonproprietary name is also known as a generic name. The INN system is managed by the World Health Organization (WHO). The INN system has been coordinated by the World Health Organization (WHO) since 1953.

The World Health Organization collaborates closely with INN experts and national nomenclature committees to select a single name of worldwide acceptability for each active substance that is to be marketed as a pharmaceutical. To avoid confusion, which could jeopardize the safety of patients, trade-marks should neither be derived from INNs nor contain common stems used in INNs.

An established INN is known as a recommended INN (rINN), while a name that is still being considered is called a proposed INN (pINN).

Nonproprietary names are intended for use in pharmacopeias, labeling, product information, advertising and other promotional material, drug regulation and scientific literature, and as a basis for product names, e.g. for generics.

The international nonproprietary names (INNs) of drugs proposed by the World Health Organization (WHO) are released for public consultation. These consultations provide an opportunity to identify any risks associated with INNs that could lead to confusion.

The national naming schemes can be country specific. That is, they refer to ingredients used in the particular country with names intended to meaningful to its citizens (e.g. BAN and USAN names: acetaminophen vs. paracetamol). As a result of ongoing international collaboration, national names in Great Britain, France, Japan or United States (USAN) are usually, with rare exceptions, identical to the INN.

The USAN Program assigns names through the USAN Council, a group of 5 volunteers nominated to the USAN Council based on their extensive, relevant knowledge and experience.

The process of assigning a United States Adopted Name (USAN), begins when a pharmaceutical firm or its representative files an application to name the substance. It ends with the statement of adoption a document that formally assigns a USAN to a particular substance. Before a statement of adoption is issued, the sponsoring firm, the USAN Council and the International Nonproprietary Names (INN) Expert Group must agree on a single name for the substance.

The INN and USAN are assigned while a drug is undergoing clinical trials. For INN, the development of a drug should generally progress up to the point of clinical trials (phase II) before an application is submitted to the INN Secretariat for name selection. For USAN, companies may apply during Phase 1 studies, but many wait until Phase 2 studies begin. Most companies want the INN and USAN before Phase 3 large-scale studies are complete, so that it will be available for publications and, when needed, to develop packaging, labeling, and promotional materials.

Timelines

INN name proposal should be submitted in-line with the deadline for WHO INN consultation conferences (usually 3 months beforehand, refer to WHO procedure, link here). INN name submissions are reviewed at the conference and feedback provided to the applicant within 30 days.

Provided one of the names has been selected without modifications, the INN will be published, however, the act of publication takes between 2-3 months but recently has taken as long as 6 months.

Once our INN is published there is a 4-month objection period. If there are no objections, you will have an approved non-USA INN.

After WHO approval, the INN is submitted to USAN which will take another 2-3 month to review and approve the name for use in the US.

There are no mechanisms to accelerate the naming process with WHO or USAN.

Overall, for INN one should assume the approval timeframe of 8-10 months and another 2-3 months to include the USAN approval for the US. You should always consider further delay as a possible risk – WHO often deals with a backlog.

There is an option to change the INN and USAN after they are approved when change is warranted e.g. in a case of medication errors involving the INN/USAN in question, proven previous trademark infringements, any other relevant nomenclature issues.

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