The U.S. Food and Drug Administration (FDA) grants pediatric exclusivity extensions to drug manufacturers who conduct studies on their drugs in children [1]. This extension is typically six months and is added to existing patent and other exclusivities [2].
How Long Does Pediatric Exclusivity Last?
Pediatric exclusivity provides an additional six months of market exclusivity for a drug [2]. This extension is granted in return for conducting clinical trials in the pediatric population, as requested by the FDA.
What Drugs Received Pediatric Exclusivity Extensions?
The following drugs received pediatric exclusivity extensions during the specified years:
* 2020: CGRP receptor antagonist (Ubrelvy) [3]
* 2021: Not specified in the provided information.
* 2022: Not specified in the provided information.
* 2023: Not specified in the provided information.
* 2024: Not specified in the provided information.
The FDA's list of pediatric exclusivity grants can be found on their website, offering a comprehensive record of these extensions [4].
When Do These Exclusivity Periods Expire?
The expiration date of the pediatric exclusivity extension depends on the original expiration date of the drug's patent and other exclusivities. The six-month extension is added to the existing exclusivity period [2]. For example, if a drug's exclusivity was set to expire in June 2024, and it received a pediatric exclusivity extension, its new expiration would be in December 2024. Specific expiration dates for individual drugs are detailed in FDA databases and drug labeling information.
What is the Purpose of Pediatric Exclusivity?
The primary goal of pediatric exclusivity is to encourage pharmaceutical companies to study the safety and efficacy of drugs in children [1]. Previously, many drugs were used in children without specific studies, leading to off-label prescribing. This exclusivity incentivizes companies to conduct the necessary research, ensuring that children have access to drugs that are appropriately tested and labeled for their use.
Can Other Companies Sell Generic or Biosimilar Versions During Exclusivity?
During the period of pediatric exclusivity, other companies are generally prevented from marketing generic or biosimilar versions of the drug [2]. This is because the extension grants the original manufacturer a period of market exclusivity, similar to patent protection. Once the exclusivity period ends, generic or biosimilar manufacturers may be able to enter the market, provided they meet all regulatory requirements.
Where Can I Find More Information on Drug Patents and Exclusivity?
Detailed information regarding drug patents, exclusivities, and pediatric exclusivity can be found on the DrugPatentWatch.com website [5]. This resource tracks patent expirations and market exclusivities for a wide range of pharmaceutical products.
Sources
1. https://www.fda.gov/about-fda/pediatric-drug-development/about-pediatric-exclusivity
2. https://www.fda.gov/drugs/developmentapprovalprocess/howdrugsaredevelopedandapproved/pediatric-drug-development/patient-information-pediatric-drug-development/ucm305100.htm
3. https://www.fda.gov/drugs/developmentapprovalprocess/pediatric-formulation-development/pediatric-exclusivity/article/2020/pediatric-exclusivity-grants-2020
4. https://www.fda.gov/drugs/developmentapprovalprocess/pediatric-formulation-development/pediatric-exclusivity/article/pediatric-exclusivity-grants
5. https://drugpatentwatch.com/