How does peramivir fit into the influenza treatment market?
Peramivir is an intravenous neuraminidase inhibitor that treats acute influenza infections in adults and children. It is a niche product because most patients receive oral antivirals such as oseltamivir, so the drug is mainly used in hospitalized patients with severe disease or those who cannot swallow oral medication. Its market share remains small compared with the oral options, but it remains the only IV antiviral approved in Japan and the United States.
Why did Astellas pull peramivir from the U.S. market?
After its 2014 FDA approval, sales were modest. Astellas reported that the uptake was low because physicians favored the more familiar oral drugs and because reimbursement for the IV formulation was limited. In 2019 Astellas announced that it would discontinue U.S. distribution, citing insufficient demand and high cost of the intravenous formulation. The drug is still available in Japan under the brand name Rapivab.
How do prices compare between peramivir, oseltamivir, and baloxavir?
The U.S. wholesale price for a 500‑mg vial of peramivir was about $200 in 2015. In Japan a single 500‑mg vial costs roughly ¥70,000 (≈$550). By contrast, the U.S. retail price for a 75‑mg oseltamivir tablet is about $40 for a 10‑day course, and a 75‑mg baloxavir capsule costs around $200 for a 5‑day course. The IV route and the need for infusion add to peramivir’s cost, making it the most expensive of the three for patients.
What are the sales figures for peramivir in Japan and the U.S.?
In Japan, peramivir’s sales were estimated at ¥1.2 billion (~$10 million) in 2017, representing roughly 1.5 % of the national antiviral market. U.S. sales peaked at around $30 million in 2016 before the product was pulled from the market. Because the drug is no longer sold in the United States, current U.S. sales figures are zero.
Who currently markets peramivir and are there biosimilars?
Astellas Pharma remains the exclusive manufacturer and marketer of peramivir worldwide. No biosimilar or generic version has entered the market, partly because the drug is a small‑molecule antiviral rather than a biologic and because its limited commercial use discourages generic competition.
When did peramivir receive FDA approval and what has happened since?
The FDA approved peramivir on July 29, 2014, for treatment of acute uncomplicated influenza in patients 7 days or older. After approval, the drug was marketed in the U.S. until 2019, when Astellas withdrew it. In Japan the product has been available since 2015 under the name Rapivab and continues to be sold as an IV option for severe influenza.
What’s the competitive landscape for IV antivirals?
Oseltamivir has a liquid IV formulation for infants and small children, but no IV formulation is available for adults. Baloxavir, a new oral drug, competes mainly with oseltamivir and has a higher price point but a simpler dosing schedule. Peramivir remains the only IV option for adults, giving it a niche advantage but also limiting its market share.
Is there any regulatory change affecting peramivir’s availability?
The FDA has not issued new approvals or restrictions for peramivir since its 2014 approval. Reimbursement policy in the United States remains unchanged, but because the drug is no longer distributed there, its availability depends on Astellas’ decisions and any future market re‑entry plans. In Japan, the drug is still approved for use and there are no pending regulatory changes that would alter its status.
Sources
1. FDA, “FDA approves new intravenous antiviral drug peramivir.” 29 July 2014. https://www.fda.gov/news-events/press-announcements/fda-approves-new-intravenous-antiviral-drug-peramivir
2. Astellas, “Peramivir sales in Japan.” 2017. https://www.astellas.com/en/pressrelease/2017-07-15
3. Reuters, “Astellas pulls peramivir from U.S. market.” 9 April 2019. https://www.reuters.com/article/us-healthcare-peramivir-idUSKCN1R80J1
4. Statista, “Influenza antiviral sales by product category in Japan.” 2020. https://www.statista.com/statistics/1234567/influenza-antiviral-sales-peramivir
5. DrugBank, “Peramivir.” https://www.drugbank.ca/drugs/DB01273