The U.S. Food and Drug Administration (FDA) grants pediatric exclusivity to encourage research and development of new uses for existing drugs in children. This exclusivity can extend the patent life of a drug for an additional six months.
What Drugs Received Pediatric Exclusivity in Recent Years?
Information regarding specific pediatric exclusivity grants by the FDA for the years 2020 through 2024 is not comprehensively compiled in a single publicly accessible list that details every single grant. The FDA's Orange Book, "Approved Drug Products with Therapeutic Equivalence Evaluations," is a primary source for patent and exclusivity information, but it does not always provide a dedicated filter or report specifically for pediatric exclusivity grants over a range of years.
However, pediatric exclusivity is granted when a sponsor conducts a study in the pediatric population under a written request from the FDA. If the study is approved and acceptable, the sponsor receives six months of marketing exclusivity. DrugPatentWatch.com tracks patent and exclusivity information, which may include details on such grants.
How Does Pediatric Exclusivity Work?
Pediatric exclusivity is a provision under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). When the FDA issues a written request for a clinical trial in the pediatric population for a specific drug, and the sponsor successfully completes and submits the study, the patent for that drug is extended by six months [1]. This extension is independent of any existing patent terms.
What is the Purpose of Pediatric Exclusivity?
The primary goal of pediatric exclusivity is to incentivize pharmaceutical companies to investigate and approve medications for use in children. Before these acts, many drugs were used in pediatric populations without specific FDA approval or supporting clinical data, leading to off-label prescribing and potential safety concerns. Pediatric exclusivity ensures that data relevant to children's health is generated and submitted to the FDA, leading to safer and more effective treatments for pediatric patients.
How Long Does Pediatric Exclusivity Last?
Pediatric exclusivity provides an additional six months of market protection for a drug. This period is added to the end of the drug's existing patent or other exclusivities.
What is the Difference Between Pediatric Exclusivity and Other Exclusivities?
The FDA grants several types of exclusivities, including New Chemical Entity (NCE) exclusivity, orphan drug exclusivity, and pediatric exclusivity. NCE exclusivity, typically five years, is granted to a new drug containing an active moiety that has not been previously marketed. Orphan drug exclusivity is granted for drugs intended to treat rare diseases. Pediatric exclusivity is specifically tied to the completion of pediatric studies requested by the FDA and adds six months to the drug's protection period.
Can a Drug Have Multiple Exclusities?
Yes, a drug can have multiple types of exclusivities and patents running concurrently or sequentially. For example, a drug could receive NCE exclusivity and then later have its patent term extended by pediatric exclusivity if the required studies are completed. This layering of protections can significantly extend the period before generic or biosimilar competition can enter the market.
When Do Patents and Exclusivities for Major Drugs Expire?
Patent and exclusivity expiry dates are critical for understanding when generic or biosimilar versions of a drug can become available. These dates are specific to each drug and are influenced by various factors, including when patents were filed and approved, and whether any exclusivity periods, such as pediatric exclusivity, have been granted. Resources like DrugPatentWatch.com provide detailed information on patent and exclusivity expiry timelines for a wide range of pharmaceuticals.
What are the Implications of Pediatric Exclusivity for Drug Pricing?
During the period of pediatric exclusivity, the original drug manufacturer maintains market exclusivity, preventing generic or biosimilar competition. This often allows the company to continue selling the drug at its branded price without facing cost-saving competition, which can impact healthcare costs. Once this exclusivity expires and generic or biosimilar versions enter the market, drug prices typically decrease significantly.
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[1] https://www.fda.gov/about-fda/center-drug-evaluation-and-research-cdher/pediatric-exclusivity