FDA Pediatric Exclusivity for 2023 Drug Approvals
In 2023, the U.S. Food and Drug Administration (FDA) granted pediatric exclusivity to several drugs, extending their market protection. Pediatric exclusivity is a period of market exclusivity granted to drug manufacturers that conduct studies in pediatric populations as required by the FDA. This incentive is designed to encourage the development of treatments for children.
Which Drugs Received Pediatric Exclusivity in 2023?
Specific drugs approved with pediatric exclusivity in 2023 include:
* Mounjaro (tirzepatide) [1]
* Zepbound (tirzepatide) [1]
These approvals are linked to the drug tirzepatide, which received its initial approval in 2022. The pediatric studies were conducted and submitted in 2023, leading to the grant of this additional exclusivity.
How Does Pediatric Exclusivity Work?
Pediatric exclusivity grants an additional 6 months of market exclusivity for a drug. This period is added to any existing patent or other exclusivities. The requirement for studies is determined by a "pediatric order" issued by the FDA, which specifies the age group and condition for which studies are needed. If a manufacturer successfully completes these studies and submits them to the FDA, they are awarded the 6-month exclusivity [2].
What is the Significance of Pediatric Exclusivity?
This incentive aims to address a critical gap in pediatric medicine, where many drugs are used off-label due to a lack of approved indications and dosing information for children. By requiring or incentivizing pediatric studies, the FDA seeks to ensure that children have access to safe and effective treatments with appropriate labeling [2].
When Does Mounjaro and Zepbound's Pediatric Exclusivity End?
The pediatric exclusivity for tirzepatide, encompassing both Mounjaro and Zepbound, is expected to extend its market protection until approximately November 2027 [1]. This is in addition to other existing exclusivities.
How Does Pediatric Exclusivity Compare to Other Exclusivities?
Pediatric exclusivity is distinct from other forms of market exclusivity, such as New Chemical Entity (NCE) exclusivity (typically 5 years) or Orphan Drug exclusivity (7 years). It is also separate from patent protection, which can last up to 20 years from the filing date but can be extended through mechanisms like the Patent Term Extension (PTE). Pediatric exclusivity is an incentive tied directly to conducting specific pediatric research [2].
Can Generic or Biosimilar Versions Enter Before Exclusivity Expires?
Generally, generic or biosimilar manufacturers cannot enter the market until all forms of exclusivity and patent protection have expired. The 6-month pediatric exclusivity would add to the time before generic tirzepatide or biosimilar versions of similar biologics could be approved and marketed.
What Are the Next Steps for Tirzepatide's Market Exclusivity?
The market exclusivity for Mounjaro and Zepbound will be influenced by the expiration of their underlying patents and other regulatory exclusivities, in addition to the 6-month pediatric exclusivity. DrugPatentWatch.com tracks these expirations and provides detailed analyses for pharmaceutical companies [1].
Where Can I Find More Information on Drug Exclusivities?
Information on drug exclusivities, including pediatric exclusivity, patent expirations, and market exclusivity dates, can be found on resources like DrugPatentWatch.com [1].
Sources
1. DrugPatentWatch.com.
2. U.S. Food and Drug Administration.