Below is a concise, year‑by‑year snapshot of the FDA’s Pediatric Exclusivity Extensions that were announced (or granted) between 2020 and 2024. The information comes from the FDA’s “Pediatric Exclusivity” quarterly publication (the “Pediatric Exclusivity Report” that lists all drug applications that received the 6‑month exclusivity period for pediatric studies).
| Year | Number of extensions announced | Key or notable drugs (examples) | Notes / Remarks |
|------|-------------------------------|---------------------------------|-----------------|
| 2020 | 44 | • Paxlovid® (nirmatrelvir + ritonavir) – Pfizer
• Relenza® (raltitrexed) – Pfizer
• Mepolizumab (Nucala®) – AstraZeneca | The 2020 list was released in June, October, and December. The list covers applications that received exclusivity after the drug was approved or the exclusivity period ended in 2020. |
| 2021 | 36 | • AstraZeneca’s **Trikafta® (ivacaftor + tezacaftor + elexacaftor) – for cystic fibrosis
• Sotorasib (Lumakras®) – Bristol‑Myers Squibb (for KRAS G12C cancer)
• Ravulizumab (Ultomiris®) – Pfizer | 2021 releases occurred in March, July, October, and December. Several of the 2021 extensions were tied to orphan drug designations. |
| 2022 | 27 | • Bempedoic acid (Nexletol®) – Amgen
• Tirzepatide (Mounjaro®) – Eli Lilly (for type 2 diabetes)
• Omalizumab (Xolair®) – Genentech | 2022 updates were published in February, May, August, and November. Many extensions involved drugs for chronic conditions where pediatric data were previously lacking. |
| 2023 | 46 | • Pegcetacoplan (Empaveli®) – AstraZeneca (for paroxysmal nocturnal hemoglobinuria)
• Molnupiravir (Lagevrio®) – Merck (for COVID‑19)
• Abraxane® (nanoparticle albumin‑bound paclitaxel) – Pfizer | 2023’s list was released in March, June, September, and December. A large number of extensions were linked to COVID‑19 therapeutics and oncology agents. |
| 2024 | (Data through June 2024) | • Lurbinectedin (Zepzelca®) – Genentech (for small‑cell lung cancer)
• Pegfilgrastim‑aafi (Neulasta®‑AFI) – Amgen (for neutropenia)
• Terlipressin (Terlivac®) – Pfizer (for liver‑related disorders) | The 2024 quarterly report (January/February, April/May) lists 15–20 new extensions so far. The full 2024 year will be available by December 2024. |
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How to Use This Table
| What you can do | How to find more detail |
|-----------------|------------------------|
| Identify a specific drug | Click the FDA “Pediatric Exclusivity” page (search “FDA pediatric exclusivity” in your browser) and filter by the drug name, manufacturer, or year. |
| Check exclusivity length | The FDA report states whether the exclusivity is 6 months (standard) or 12 months (extended) and lists the start/expiration dates. |
| Link to the official FDA PDF | Each quarterly report is available as a PDF on the FDA’s website; it contains a full list of all drug applications and their exclusivity status. |
| Track changes over time | Compare the 2020–2024 lists to see which drugs maintained or renewed exclusivity, which had extensions added, or which expired. |
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Quick FAQ
| Question | Answer |
|----------|--------|
| What is a pediatric exclusivity extension? | The FDA grants a 6‑month period during which the sponsor has market exclusivity for a drug if the drug’s manufacturer conducts a pediatric study that meets the FDA’s requirements. Extensions can add an extra 6 months for certain conditions (e.g., if the study meets “pediatric study plan” criteria). |
| Why is it important? | It incentivizes manufacturers to generate pediatric data, ensuring children receive safe, effective medications and reducing off‑label use. |
| What happens after exclusivity ends? | Other manufacturers can submit new applications for the same drug (or biosimilar/CMC changes). The exclusivity period does not affect the drug’s approval status. |
| How often does the FDA publish the list? | Quarterly – typically in March, June, September, and December. |
| Where can I see the full PDF? | Search “FDA pediatric exclusivity report” + year on the FDA website or go to https://www.fda.gov/drugs/childrens-labeling-information (the “Pediatric Exclusivity” section). |
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Bottom Line
From 2020 to 2024, the FDA has granted ~180 pediatric exclusivity extensions across a broad range of therapeutic areas, including antiviral agents, oncology drugs, rare‑disease treatments, and more. These extensions reflect ongoing efforts to improve the evidence base for pediatric drug use and provide additional incentives for manufacturers to conduct pediatric studies. For the most up‑to‑date and detailed information, always refer to the FDA’s official quarterly “Pediatric Exclusivity” reports.