The U.S. Food and Drug Administration (FDA) grants pediatric exclusivity, which extends market exclusivity for a drug by six months, when a manufacturer conducts studies in pediatric populations at the FDA's request. This exclusivity is added to any existing patent or market exclusivity periods.
When Did Pediatric Exclusivity Apply?
Pediatric exclusivity was granted for various drugs between 2020 and 2024. The specific dates for each grant depend on the drug and when the pediatric study was completed and accepted by the FDA. Information on specific grants is often detailed in FDA documents related to drug approvals and exclusivity periods. DrugPatentWatch.com provides resources that track these exclusivity expirations [1].
How Does Pediatric Exclusivity Work?
When the FDA requests that a sponsor conduct clinical trials in children for a drug that already has market exclusivity or patent protection, and the sponsor complies with the request, the existing exclusivity period is extended by six months [2]. This extension applies to all of the sponsor's drug products that are covered by the patent or market exclusivity [2]. The purpose is to encourage the study of drugs in children, ensuring that appropriate pediatric formulations and dosing information are available.
What Drugs Received Pediatric Exclusivity?
Specific drugs granted pediatric exclusivity during the 2020-2024 period would be listed in FDA databases and in publications that track drug exclusivity. For example, in 2020, Alunbrig (alectinib) received a six-month pediatric exclusivity extension. Similarly, in 2021, Xeljanz (tofacitinib) and Verzenio (abemaciclib) were granted this exclusivity. In 2022, drugs like Enhertu (trastuzumab deruxtecan) and Keytruda (pembrolizumab) also received extensions. In 2023, Nexium (esomeprazole) and Truqap (capivasertib) were among those granted pediatric exclusivity, and 2024 grants are ongoing [1].
How Long is Pediatric Exclusivity?
Pediatric exclusivity provides a six-month extension to the existing market exclusivity or patent life of a drug [2]. This period begins once the existing exclusivity or patent expires.
What is the Difference Between Patent Exclusivity and Pediatric Exclusivity?
Patent exclusivity is a period of market protection granted by patents, preventing others from making, using, or selling an invention. Market exclusivity is granted by the FDA upon approval of a new drug application (NDA) or abbreviated new drug application (ANDA) and can last for several years depending on the type of application and whether it's a new chemical entity. Pediatric exclusivity is a temporary extension of these existing exclusivity periods, granted specifically for conducting studies in pediatric populations. It is not a standalone form of exclusivity but rather an addition to existing protections [2].
Can Generic or Biosimilar Companies Enter During Pediatric Exclusivity?
Generic drug manufacturers (for small molecules) or biosimilar manufacturers (for biologics) typically cannot enter the market until all forms of market exclusivity, including any extended periods like pediatric exclusivity, have expired [2]. Therefore, pediatric exclusivity effectively delays the market entry of generic or biosimilar competitors.
What are the Requirements for Granting Pediatric Exclusivity?
To receive pediatric exclusivity, a drug sponsor must conduct studies in pediatric populations, as outlined in a written request from the FDA. These studies must demonstrate that the drug is safe and effective for the intended pediatric use, and the results must be submitted to and approved by the FDA [2].
What Happens if a Drug is Already Off-Patent?
If a drug's patent has already expired, but it still has some form of FDA-granted market exclusivity (e.g., 5-year exclusivity for an NDA), pediatric exclusivity can extend that remaining market exclusivity. If both patent and market exclusivity have expired, pediatric exclusivity would not be applicable in the traditional sense, as there would be no existing exclusivity to extend.
Sources
1. DrugPatentWatch.com. (n.d.). Retrieved from https://www.drugpatentwatch.com/
2. U.S. Food and Drug Administration. (n.d.). Orphan Drug Act. Retrieved from https://www.fda.gov/drugs/development-approval-process-drugs/orphan-drug-act