Abstract:

The Approved Drug Products with Therapeutic Equivalence Evaluations (commonly known as the Orange Book) includes the products approved by Food and Drug Administration (FDA) to be marketed in the USA, and it is an essential source for the selection of suitable reference listed drugs (RLD) for a chemical generic medicinal product. The Orange Book assigns a therapeutic equivalence (TE) evaluation code for approved multisource prescription drug products to serve as public information in the area of medicinal product selection. In the present study, we introduced the TE coding system and its influence on the selection of the RLD in China by taking the Topiramate Extended-release Capsules as an example. As a result, it was suggested to determine its TE evaluation code in the Orange Book previously when we choose an RLD and select suitable RLD the first letter of whose TE evaluation code is A to carry out the research and development of a generic medicinal product, which can improve the probability of success of clinical bioequivalence (BE) test and reduce the risk of generic medicinal product development.

Key words: Reference listed drug, Therapeutic equivalence evaluations code, Generic medicinal product, Orange Book