FDA Pediatric Exclusivity Granted in 2021
The U.S. Food and Drug Administration (FDA) granted pediatric exclusivity to several drugs in 2021. This exclusivity extends the market protection period for a drug by six months if the manufacturer conducts studies in pediatric populations as requested by the FDA.
What are the key drugs that received FDA pediatric exclusivity in 2021?
In 2021, pediatric exclusivity was granted to drugs such as Vanda Pharmaceuticals' HETLIOZ (tafenoquine succinate) for the treatment of non-24-hour wakefulness disorder in blind individuals [1]. Other approvals may have occurred, but specific lists are often associated with individual drug approvals and may not be aggregated annually by the FDA.
How does pediatric exclusivity work?
Pediatric exclusivity is an incentive for drug manufacturers to conduct clinical trials in children. When the FDA requests these studies and the manufacturer successfully completes them, the drug's patent or other forms of market exclusivity are extended by six months [2]. This extension is intended to ensure that safe and effective treatments are available for pediatric patients, a population often underrepresented in initial drug development [3].
When does pediatric exclusivity typically expire?
The six-month period of pediatric exclusivity is added to the end of the drug's existing market exclusivity, whether that be patent protection or other FDA-granted exclusivities [2]. Therefore, the expiration date depends on the original expiration of the drug's other protections.
Can drug manufacturers choose not to pursue pediatric exclusivity?
While drug manufacturers can choose not to conduct pediatric studies, the FDA may request them as part of the drug approval process. If a request is made and studies are completed successfully, the pediatric exclusivity is typically granted [2].
How does pediatric exclusivity compare to other forms of FDA exclusivity?
The FDA grants various forms of market exclusivity, including:
* New Chemical Entity (NCE) exclusivity: Typically 5 years for a new drug [4].
* Orphan Drug exclusivity: 7 years for drugs treating rare diseases [4].
* Pediatric exclusivity: 6 months, granted upon completion of required pediatric studies [2].
* Patent extensions: Such as those under the Hatch-Waxman Act, which can extend patent life to compensate for regulatory delays [5].
Pediatric exclusivity is specifically tied to studies in children and adds a defined period to existing protections.
What is the impact of pediatric exclusivity on drug pricing?
By extending market exclusivity, pediatric exclusivity can delay the entry of lower-cost generic or biosimilar competition. This delay allows the original manufacturer to continue selling the drug at its branded price for an additional six months, potentially impacting overall healthcare costs [3].
Where can I find more detailed information on drug patent expirations and exclusivity?
For detailed information on drug patents, exclusivities, and their expiration timelines, resources like DrugPatentWatch.com are available [1].
Sources
1. DrugPatentWatch.com
2. U.S. Food and Drug Administration
3. FDA Center for Drug Evaluation and Research
4. U.S. Food and Drug Administration, "Guidance for Industry: Applications for Permits for Scientific and Technological Development Programs"
5. Hatch-Waxman Act