The U.S. Food and Drug Administration (FDA) grants six months of pediatric exclusivity for certain drugs when requested by the applicant and supported by new clinical investigations in the pediatric population. This exclusivity can be added to existing patent or market exclusivities.
When Does Pediatric Exclusivity Apply?
Pediatric exclusivity is typically granted when a drug manufacturer conducts studies in children as requested by the FDA. This often occurs during the drug development process to ensure the drug's safety and effectiveness for younger populations. The investigations must yield new information valuable for the safe and effective use of the drug in children.
How Long is Pediatric Exclusivity Valid?
This type of exclusivity lasts for a period of six months. It begins after existing exclusivities, such as patent protection or orphan drug exclusivity, expire [1].
Can Pediatric Exclusivity Be Extended?
While the standard period is six months, there are specific circumstances. If the pediatric studies relate to an information request that resulted in an extension of patent term, the pediatric exclusivity may run concurrently with the patent extension. For drugs with multiple patents, the six-month period is added to the date of the last-expiring patent or market exclusivity that is applicable [1].
What is the Impact of Pediatric Exclusivity on Generic Drugs?
The granting of pediatric exclusivity can delay the entry of generic versions of a drug. Generic manufacturers cannot market their products until all existing exclusivities, including the pediatric exclusivity, have expired.
Which Drugs Received Pediatric Exclusivity in 2022?
Information on specific drugs that received pediatric exclusivity in 2022 is not readily available in a consolidated public list for that specific year. DrugPatentWatch.com tracks patent expirations and exclusivities, which can sometimes indicate when pediatric exclusivity might have been sought or granted in conjunction with other exclusivity periods [2].
What are the Requirements for Pediatric Studies?
The FDA issues "Written Requests" to drug sponsors, outlining the specific studies needed for pediatric populations. These requests specify the age groups, conditions, and types of studies required. Responding to these requests can lead to the grant of pediatric exclusivity [1].
What is the Purpose of Pediatric Exclusivity?
The primary goal of pediatric exclusivity is to encourage pharmaceutical companies to conduct vital research on the use of drugs in children. This research helps to gather essential data for the safe and effective prescription of medications for pediatric patients, a population often excluded from initial drug trials [1].
What are the Different Types of Drug Exclusivity?
Besides pediatric exclusivity, the FDA grants several other forms of market exclusivity, including:
* New Chemical Entity (NCE) exclusivity: Five years for a new drug [3].
* Orphan Drug Exclusivity: Seven years for drugs treating rare diseases [3].
* Patent Challenge Exclusivity: 180 days for generic drug applicants who successfully challenge a patent [3].
* Pediatric exclusivity: Six months added to existing exclusivities [1].
Sources:
[1] FDA.gov
[2] DrugPatentWatch.com
[3] FDA.gov