Drug Development Consultant and Regulatory Consultant

Data Exclusivity Extends Market Protection to 11 years without a patent being required

Data exclusivity is an important tool in the area of pharmaceuticals and biological therapies, when you successfully apply for a product license in many European countries. This period of data exclusivity was originally implemented to cover areas where patent protection was limited. When a generic application is made for an existing drug, the pre-clinical and clinical work is not repeated instead the generic applicant references the existing products regulatory filing which the authorities hold. Data exclusivity means that for the period the regulatory authorities will not allow your data to be used for generic applications. This does not guarantee market exclusivity but it does increase the work load and expense required from a generic manufacture who is seeking to launch a product. Data exclusivity last for 8 years in the majority of European countries, then there is an additional 2 years of market exclusivity after this point, during which generic applications can be filed and considered but no licenses will be awarded until the period ends this allows a 10 year market exclusivity. Another important note is that if a new indication is filed in the first 8 years an additional year of data exclusivity can be added on brining total protection up to 11 years. This extra year can also be applied if the product successfully switches from Prescription only to Over the Counter.

This can be a great tool if your seeking a new indication for an existing generic drug, or if your development has taken a long time which has resulted in only a short time left on your patent when you complete your licensing applications.

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology), we work with our clients to define a development target, define a development strategy, define a regulatory strategy or define a commercial strategy. Our clients are generally raising funds or looking to license out their technology and we help them achieve it.

If you want to know more don’t hesitate to get in touch using the contact form or email Damien at damien.bove@idaconsultants.com