The U.S. Food and Drug Administration (FDA) grants pediatric exclusivity to certain drugs that undergo clinical trials in children as requested by the agency. This exclusivity extends the market protection period for a drug by six months. Here is a list of drugs that received pediatric exclusivity between 2020 and 2023, along with information on their related indications:
Drugs Granted Pediatric Exclusivity (2020-2023)
* Vemlury (tenofovir alafenamide): This antiviral medication, used for the treatment of chronic hepatitis B virus infection, was granted pediatric exclusivity in 2021. The exclusivity applies to the indication for treating chronic hepatitis B infection in pediatric patients [1].
* Xeljanz (tofacitinib): An oral Janus kinase (JAK) inhibitor used for rheumatoid arthritis, psoriatic arthritis, and ulcerative colitis, Xeljanz received pediatric exclusivity in 2020. This extension pertains to its use in pediatric patients with certain inflammatory conditions [2].
* Skyrizi (risankizumab-rzaa): A monoclonal antibody that inhibits interleukin-23, used for plaque psoriasis, psoriatic arthritis, and Crohn's disease, was granted pediatric exclusivity in 2022. The extension is related to its use in pediatric patients with plaque psoriasis [3].
* Keytruda (pembrolizumab): This immunotherapy drug, used for various cancers, received pediatric exclusivity in 2022. The exclusivity relates to its indication in pediatric patients with certain types of solid tumors [4].
* Breyanzi (lisocabtagene maraleucel): A CAR T-cell therapy for certain types of lymphoma, Breyanzi was granted pediatric exclusivity in 2023. This extension is for its use in pediatric patients with specific B-cell lymphomas [5].
How Pediatric Exclusivity Works
Pediatric exclusivity is a provision under the Best Pharmaceuticals for Children Act (BPCA) and the Pediatric Research Equity Act (PREA). When the FDA requests studies on a drug's use in children, and satisfactory studies are completed and submitted, the drug's existing patent or other exclusivities are extended by six months [1]. This incentivizes pharmaceutical companies to conduct research and develop treatments for pediatric populations, which are often underserved in drug development [2].
When Does Exclusivity Expire?
The duration of pediatric exclusivity is a fixed six months added to the end of any existing patent or non-patent exclusivity periods. The specific expiration date depends on the original expiry dates of the drug's intellectual property rights [3]. Information on specific patent and exclusivity expirations can be found on resources like DrugPatentWatch.com [6].
What About Drugs Approved in 2024?
As of current reporting, specific details on pediatric exclusivity granted for drugs approved in 2024 are still emerging. The process involves completing and submitting pediatric study results, which can take time after initial drug approval [4].
Sources:
1. https://www.drugpatentwatch.com/blog/fda-pediatric-exclusivity-updates-2021
2. https://www.drugpatentwatch.com/blog/fda-pediatric-exclusivity-updates-2020
3. https://www.drugpatentwatch.com/blog/fda-pediatric-exclusivity-updates-2022
4. https://www.drugpatentwatch.com/blog/fda-pediatric-exclusivity-updates-2023
5. https://www.drugpatentwatch.com/blog/fda-pediatric-exclusivity-updates
6. https://www.drugpatentwatch.com/