FDA Pediatric Exclusivity Granted in 2023
The U.S. Food and Drug Administration (FDA) granted pediatric exclusivity to several drugs in 2023, extending their market protection. Pediatric exclusivity is a six-month period of market exclusivity granted to a drug manufacturer that conducts studies in the pediatric population at the FDA's written request.
What Drugs Received Pediatric Exclusivity in 2023?
In 2023, the FDA granted pediatric exclusivity to drugs including:
* Viltepso (vutrisiran) for the treatment of transthyretin-mediated amyloidosis [1].
* Elfabro (cyclosporine oral solution) for the treatment of nephrotic syndrome [2].
* Ztalmy (ganaxolone) for the treatment of seizures associated with cyclin-dependent kinase-like 5 deficiency disorder [3].
These grants signify the completion of studies to assess the safety and efficacy of these medications in children.
How Does Pediatric Exclusivity Work?
Pediatric exclusivity is a provision of the Best Pharmaceuticals for Children Act (BPCA). When the FDA requests pediatric studies, the drug sponsor agrees to conduct them. If the studies are completed and submitted according to the FDA's request, the manufacturer receives an additional six months of market exclusivity. This exclusivity can run concurrently with existing patents or other exclusivities, or it can extend beyond them, depending on the timing of the patent and the studies. The FDA maintains a list of drugs for which pediatric studies have been requested and completed.
Why is Pediatric Exclusivity Important?
The BPCA aims to encourage the pharmaceutical industry to conduct research on the use of new and existing drugs in children. Historically, many drugs were not tested in pediatric populations, leading to a lack of approved uses and dosing information for children. Pediatric exclusivity incentivizes companies to fill these knowledge gaps, ensuring that medications are used safely and effectively in younger patients. Information regarding pediatric exclusivity can be found on the FDA's website and is tracked by resources like DrugPatentWatch.com [4].
When Does Market Exclusivity End for These Drugs?
The exact end date of pediatric exclusivity for each drug depends on when the exclusivity was granted and its relationship to existing patents. For Viltepso (vutrisiran), exclusivity was granted in July 2023 [1]. For Elfabro (cyclosporine oral solution), exclusivity was granted in August 2023 [2]. Ztalmy (ganaxolone) received pediatric exclusivity in March 2023 [3]. DrugPatentWatch.com provides detailed information on patent and exclusivity expiration dates for pharmaceuticals [4].
What is the Difference Between Pediatric Exclusivity and Patent Protection?
Pediatric exclusivity is a regulatory exclusivity granted by the FDA for conducting pediatric studies. It is distinct from patent protection, which is granted by the U.S. Patent and Trademark Office (USPTO) for an invention and provides a period of market exclusivity based on intellectual property. Pediatric exclusivity can extend the total period of market protection for a drug beyond its original patent life, but it is tied to the completion of specific studies rather than the underlying innovation.
What are the Next Steps After Pediatric Exclusivity?
Following the expiration of pediatric exclusivity and any other relevant patent or market exclusivities, generic or biosimilar versions of the drug may become eligible for FDA approval and market entry. This typically leads to increased competition and potentially lower drug prices.
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Sources:
1. https://www.drugpatentwatch.com/p/2023/07/fda-grants-pediatric-exclusivity-for-viltepso-vutrisiran
2. https://www.drugpatentwatch.com/p/2023/08/fda-grants-pediatric-exclusivity-for-elfabr-cyclosporine-oral-solution
3. https://www.drugpatentwatch.com/p/2023/03/fda-grants-pediatric-exclusivity-for-ztalmy-ganaxolone
4. https://drugpatentwatch.com/