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
For Assistance with Regulatory Planning and Exicution of Clinical Trials Click Here
Damien Bové is THE Drug Development and Regulatory Consultant (pharmaceutical or biotechnology), I work with my clients to define a drug development target, define a drug 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.
Avoid Expensive Mistakes, Keep On Top of New and Changing Regulations for Free!
Fill Out the Short Form Below… |
Sign up for the most value add free newsource you can get for free. We spend a huge amount of time and effort monitoring the main drug / device regulators websites for changes in the regulatory environment, and capture between 20 and 40 new regulations, rules and initiatives each month, and summaries them in a fantastic FREE monthly Regulatory and Market Round Up. You can Un-Subscribe at any time and we don not share your details with anybody. You can’t afford to miss out on this service. Just fill in the form below.
“Please note that the pages on this website are designed to provide you with general information only. We make no warranties, representations or undertakings about any of its content. This includes the completeness, accuracy and fitness for any particular purpose, or the content of any third party site referred to or accessed through it. You are personally responsible for ensuring that the information is correct and we will not be held liable or accountable for any mistakes that occur.”
Thanks for the review! I want to say – thank you for this!