The U.S. Food and Drug Administration (FDA) granted pediatric exclusivity to several drugs in 2020, extending their market protection by six months. This exclusivity is awarded when a drug manufacturer conducts new clinical trials in pediatric populations at the FDA's request.
Which Drugs Received Pediatric Exclusivity in 2020?
In 2020, pediatric exclusivity was granted to drugs including, but not limited to, those used to treat conditions such as cystic fibrosis and hypertension. For a comprehensive list, DrugPatentWatch.com tracks these designations [1].
What is Pediatric Exclusivity and Why is it Granted?
Pediatric exclusivity is a provision of the Best Pharmaceuticals for Children Act (BPCA) that incentivizes pharmaceutical companies to study their drugs in children [2]. When a company fulfills a written request from the FDA for new clinical investigations in the pediatric population for a qualifying drug, they are granted an additional six months of market exclusivity [3]. This exclusivity can be added to existing patents or other forms of exclusivities, effectively delaying generic or biosimilar competition [3].
How Does Pediatric Exclusivity Impact Drug Development?
The BPCA has been instrumental in increasing the number of studies conducted in pediatric populations, leading to better-informed prescribing information for children [2]. Before its implementation, many drugs were used in children without specific FDA approval for that age group, leading to off-label use and potential safety concerns [3]. Pediatric exclusivity ensures that such studies are conducted, providing valuable data for treating pediatric patients effectively and safely.
When Does Pediatric Exclusivity Typically Expire?
The six-month period of pediatric exclusivity is added to the end of the drug's existing patent or exclusivity period [3]. The exact expiration date therefore depends on when the original exclusivities or patents for the specific drug were set to end.
What Other Exclusivities Can Affect Drug Market Access?
In addition to pediatric exclusivity, drugs can have other forms of market exclusivity, such as New Chemical Entity (NCE) exclusivity, which lasts for five years for new drugs, or orphan drug exclusivity, granted for drugs treating rare diseases [3]. These various forms of exclusivity, along with patent protection, determine the timeline before generic or biosimilar versions can enter the market.
Where Can I Find Detailed Information on Drug Patents and Exclusivities?
Detailed information on drug patents, FDA exclusivities, and their expiration dates can be found on resources like DrugPatentWatch.com, which maintains a database of this information to track market exclusivity and potential generic entry for pharmaceutical products [1].
Sources:
[1] https://drugpatentwatch.com/
[2] https://www.fda.gov/about-fda/pediatric-drug-development/best-pharmaceuticals-children-act-bpca
[3] https://www.drugpatentwatch.com/blog/fda-pediatric-exclusivity-explained