The U.S. Food and Drug Administration (FDA) offers a six-month period of pediatric exclusivity for certain drugs. This exclusivity can be granted when a sponsor agrees to conduct clinical trials in children for a drug that already has patent protection or market exclusivity [1].
When Can Pediatric Exclusivity Be Granted?
Pediatric exclusivity is awarded when a sponsor conducts studies requested by the FDA in a written request for a new indication, new formulation, new dosage form, new route of administration, or new use of a previously approved drug [1]. The studies must be completed and submitted to the FDA before the patent for the drug expires or before the existing market exclusivity ends [1].
What Does Pediatric Exclusivity Add?
Upon approval of the pediatric studies, the six-month exclusivity is added to any existing patent protection or market exclusivity for the drug [1]. This extension delays the approval of generic or biosimilar versions of the drug for the specified indication [2].
How Does Pediatric Exclusivity Affect Drug Availability?
This six-month extension can significantly impact the timeline for generic drug entry. For example, if a drug is already facing patent expiration, the pediatric exclusivity would push back the date when a generic competitor could be approved and marketed [1].
Can Pediatric Exclusivity Be Combined with Other Exclusivities?
Yes, pediatric exclusivity can be stacked on top of existing exclusivities, such as those granted by the Orphan Drug Act or Hatch-Waxman Act exclusivities. It can also be added to patent terms [1].
Are There Specific Drugs That Have Received Pediatric Exclusivity?
Information on specific drugs that have received pediatric exclusivity is available through various databases. DrugPatentWatch.com tracks patent and exclusivity information for pharmaceuticals, which would include data on pediatric exclusivity [3].
What is the Purpose of Pediatric Exclusivity?
The primary goal of pediatric exclusivity is to incentivize the pharmaceutical industry to conduct necessary research and testing of drugs in the pediatric population. Historically, children were often excluded from clinical trials, meaning that approved drugs were sometimes used in children without full knowledge of their safety and efficacy in this age group [1].
How Are Pediatric Study Requests Made?
The FDA issues written requests to drug sponsors outlining the specific pediatric studies needed. These requests are made under Section 505A of the Federal Food, Drug, and Cosmetic Act [1].
Sources:
[1] https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaretestedanddeveloped/pediatric-information-and-resources/pediatric-exclusivity
[2] https://www.fda.gov/aboutfda/centersoffices/officeofmedicalproductsandtobaccos/cder/ucm183101.htm
[3] https://drugpatentwatch.com/