There are 4 kinds of ‘Therapeutic Switch’, or drug repurposing project:

Project type


Compound on the market and still under original composition of matter patent protection

Mainly for the original marketing company, hampered by a risk of adverse clinical findings damaging the market for the primary indication

Compound on the market, but off patent

Risk of generic (‘off-label’) competition, alleviated by product differentation

Compound not fully developed for original indication

Lower risk of competition from generic competition, greater risk of adverse toxicology, smaller patient safety database

Stereoisomer or metabolite of an existing racemate

Some preclinical development to be done, and need to differentiate from existing racemic drug

There are nuances to avoid some of the generic substitution issues based on an understanding of the issues around off-label use, some skills in defining the regulatory pathway, and geographic differences between regulatory environments in EU and US. In addition, experience in defining a patent position and and prosecution are important. These are exactly the areas where Numedicus can help.