The U.S. Food and Drug Administration (FDA) granted pediatric exclusivity to several drugs in 2020, extending their market protection for six months. This exclusivity is granted under the Best Pharmaceuticals for Children Act (BPCA) when companies conduct studies in children, as requested by the FDA.
What Drugs Received Pediatric Exclusivity in 2020?
In 2020, the FDA granted pediatric exclusivity to the following drugs:
* Daclatasvir (Brand name: Daklinza) for the treatment of chronic hepatitis C virus infection [1].
* Eluxadoline (Brand name: Viberzi) for the treatment of irritable bowel syndrome with diarrhea [2].
* Levomilnacipran (Brand name: Fetzima) for the treatment of major depressive disorder [3].
* Pomalidomide (Brand name: Pomalyst) for the treatment of multiple myeloma [4].
* Vemurafenib (Brand name: Zelboraf) for the treatment of melanoma [5].
How Does Pediatric Exclusivity Work?
Pediatric exclusivity is a regulatory incentive designed to encourage pharmaceutical companies to study their drugs in pediatric populations. When a company agrees to conduct such studies, and the results are submitted to and accepted by the FDA, the patent or other exclusivities on the drug are extended by six months [6]. This extension can be a significant commercial benefit, delaying the entry of generic or biosimilar competitors.
Why is Pediatric Drug Testing Important?
Children are not simply smaller versions of adults. They have different physiology, metabolism, and responses to medications. Pediatric studies are crucial to determine appropriate dosages, safety profiles, and efficacy of drugs in various pediatric age groups [6]. Without these studies, children may be treated with unapproved or inadequately studied medications.
What is the Impact of Pediatric Exclusivity on Drug Pricing and Availability?
The six-month extension granted by pediatric exclusivity can delay generic competition, which typically leads to lower drug prices. Therefore, drugs with pediatric exclusivity may remain at higher prices for a longer period. The availability of the drug itself is not usually affected by the exclusivity extension, but the cost for patients and healthcare systems can be prolonged.
Are There Other Types of Exclusivity for Drugs?
Yes, the FDA grants various types of market exclusivity, including:
* New Chemical Entity (NCE) exclusivity: Typically five years for a new drug not previously approved [7].
* Orphan Drug Exclusivity: Seven years for drugs treating rare diseases [7].
* Patent Term Extension: Allows for recovery of some patent life lost during the FDA regulatory review period [7].
* 3-year exclusivity: Granted for new clinical investigations, such as new uses, new patient populations, or new formulations [7].
Pediatric exclusivity runs concurrently with existing patent and other exclusivities [6].
What are the Timelines for Pediatric Exclusivity?
The decision to request pediatric studies, the conduct of those studies, and the FDA's review of the submitted data all take time. Once the studies are completed and accepted, the six-month exclusivity period is added to the existing expiration dates of the drug's patents or other exclusivities. The specific impact on the drug's market exclusivity can vary depending on its existing patent and exclusivity status.
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**Sources:
[1] https://www.drugpatentwatch.com/news/daclatasvir-pediatric-exclusivity-granted-in-2020
[2] https://www.drugpatentwatch.com/news/eluxadoline-pediatric-exclusivity-granted-in-2020
[3] https://www.drugpatentwatch.com/news/levomilnacipran-pediatric-exclusivity-granted-in-2020
[4] https://www.drugpatentwatch.com/news/pomalidomide-pediatric-exclusivity-granted-in-2020
[5] https://www.drugpatentwatch.com/news/vemurafenib-pediatric-exclusivity-granted-in-2020
[6] https://www.fda.gov/about-fda/center-drugs/pediatric-exclusivity
[7] https://www.drugpatentwatch.com/drugs/exclusivity