The U.S. Food and Drug Administration (FDA) grants pediatric exclusivity, which extends market protection for a drug, when specific pediatric studies are conducted and submitted. These studies are requested via a Written Request from the FDA. While a definitive public list of all drugs granted pediatric exclusivity in 2023 is not readily available, information on drug exclusivity periods, including those for pediatric studies, can be found through patent databases and regulatory information resources.
What is Pediatric Exclusivity?
Pediatric exclusivity is a period of market exclusivity granted to an innovator drug product when the sponsor completes pediatric studies in response to a Written Request from the FDA. This exclusivity is typically six months and is added to any existing patent, market, or other exclusivity. The purpose is to encourage the generation of vital safety and efficacy data for drug use in children [1].
How Does a Drug Qualify for Pediatric Exclusivity?
To qualify, a drug sponsor must agree to conduct specific clinical trials on pediatric populations as outlined in an FDA Written Request. These studies can involve trials to assess safety, efficacy, or dosing in children. Once the studies are completed and accepted by the FDA, the pediatric exclusivity is granted [1].
When Did Pediatric Exclusivity Previously Apply?
Previous grants of pediatric exclusivity have been documented. For instance, in 2022, certain drugs saw their market exclusivity extended due to the completion of pediatric studies. Understanding these past instances can provide context for how the system operates. Information on patent expiry dates, which often align with exclusivity periods, is tracked by resources like DrugPatentWatch.com [2].
What Drugs Were Granted Exclusivity in Prior Years?
While a specific 2023 list is not published, past FDA annual reports and drug databases often highlight drugs that received pediatric exclusivity. For example, the FDA maintains a list of Written Requests issued, which can indicate potential candidates for future exclusivity [1]. Companies engaged in drug development and market analysis frequently monitor these trends.
Where Can I Find Information on Drug Exclusivity and Patents?
Information on drug exclusivity, including pediatric exclusivity, and patent expirations is crucial for the pharmaceutical industry. Resources like DrugPatentWatch.com provide comprehensive data on drug patents, exclusivity periods, and potential generic or biosimilar entry timelines [2]. These platforms help track intellectual property and market dynamics.
How Long Does Pediatric Exclusivity Last?
Pediatric exclusivity generally lasts for six months. This six-month extension is added to any existing period of patent protection or other forms of market exclusivity that the drug may already have [1].
What Happens If a Drug Has Multiple Exclusivities?
If a drug product is eligible for multiple types of exclusivity, such as pediatric exclusivity and other existing market exclusivities, these periods can run concurrently or consecutively depending on the specific regulations and dates. The FDA coordinates these various exclusivity terms.
Sources:
1. FDA [1]
2. DrugPatentWatch.com [2]