Pediatric Exclusivity After Product Approval; FDA Interpriations About Which You Might Not Be Aware

admin — Wed, 08 Apr 2009 08:18:46 +0000

This is a very interesting article that raises some good points well worthy of consideration published on FDA Law Blog run by Hyman, Phelps & McNamara, In summary the FDA grants an additional period of exclusivity for a licensed product for a period of 6 months, if the sponsor submits requested information relating to the use of the active moiety in the paediatric population. There are a number of rules and regulations involved in obtaining this exclusivity (perhaps a full article on this subject is justified – I will try and get one in this week). However what this interesting article points out is that the FDA’s interpretation of the benefits goes beyond what you may think and their points of view are justified with case studies.

FDA statement

“Pediatric exclusivity will attach to exclusivity and patent protection listed in the Orange Book for any drug product containing the same active moiety as the drug studied and for which the party submitting the studies holds the approved new drug application (505A(a) and (c)). For studies conducted on an unapproved drug, pediatric exclusivity will also attach to any exclusivity or patent protection that will be listed in the Orange Book upon approval of that unapproved drug. FDA will attach pediatric exclusivity to protections listed at any time for a drug product as approved at the time pediatric exclusivity is obtained, as described further in section X.C.”

FDA statement

“Previously earned pediatric exclusivity will not apply to new patents or exclusivity covering later-filed applications or supplements containing the same active moiety for which a sponsor previously earned pediatric exclusivity, unless the data that earned the prior pediatric exclusivity is essential to approval of the new application or supplement.”

Interesting interpretation:

When the FDA issues a Paediatric Written Request (PWR) for a drug product that is a racemic mixture, any pediatric exclusivity granted as a result of that PWR applies not only to the to the racemic mixture but also to the sponsors other products containing either enantiomer whether or not FDA’s PWR specifically identifies each enantiomer in the racemic mixture.

previously earned pediatric exclusivity can apply to certain new Orange Book-listed patents if those patents relate back to the drug product when pediatric exclusivity was granted.

If you would like more detail in this area please get in touch with Damien Bové damien.bove@idaconsultants.com

Damien Bové works as a drug development consultant (pharmaceutical or biotechnology) and regulatory consultant, we work with our 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.

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

admin — Mon, 19 Jan 2009 09:41:11 +0000

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

Drug Development Consultant & Regulatory Consultant » Data Exclusitity

Pediatric Exclusivity After Product Approval; FDA Interpriations About Which You Might Not Be Aware

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