Last updated: February 20, 2026
Who manufactures Dayvigo?
Dayvigo (lemborexant) is produced by Eisai Co., Ltd. Since its U.S. approval in December 2019, Eisai has been the sole supplier responsible for commercializing and distributing the drug.
Is Dayvigo available from multiple suppliers?
Yes. While Eisai holds the manufacturing rights, several authorized pharmaceutical distributors supply Dayvigo to pharmacies, hospitals, and healthcare providers. These distributors include:
- Cardinal Health
- McKesson
- AmerisourceBergen
They act as intermediaries, ensuring drug availability across markets.
Manufacturing location and capacity
Eisai's primary manufacturing facilities for Dayvigo are located in Japan and the United States. Details about production capacity remain confidential, but the company has invested in expanding manufacturing facilities to meet rising demand.
Supply chain considerations
- Exclusivity: Eisai maintains exclusive rights to Dayvigo's production, limiting supply to licensed partners.
- Distribution: Authorized distributors hold distribution licenses compliant with the FDA and other regulatory bodies.
- Global reach: As of 2023, Dayvigo is approved in the U.S., Japan, and the European Union, with supply chains established through local distributors.
Regulatory status and implications
Eisai filed for approvals in various markets with the expectation that sole manufacturing rights would streamline regulatory compliance. In some jurisdictions, local licensing agreements are required for distribution.
Summary table
| Aspect |
Details |
| Manufacturer |
Eisai Co., Ltd. |
| Authorized suppliers |
Cardinal Health, McKesson, AmerisourceBergen |
| Manufacturing sites |
Japan, United States |
| Distribution channels |
Licensed pharmaceutical distributors |
| Regulatory approvals |
U.S. (FDA), Japan (PMDA), EU (EMA) |
| Global availability |
Limited to markets with approved licenses |
Notes on supply chain risks
Eisai's reliance on specific manufacturing sites poses potential risks, such as supply disruptions due to natural disasters, geopolitical issues, or regulatory changes. The company has strategies to mitigate such risks, including expanding manufacturing capacity.
Final considerations
Eisai remains the exclusive source of Dayvigo production. Authorized distributors facilitate market supply, ensuring availability. No generic or multiple third-party manufacturers are licensed for Dayvigo production at this time.
Key Takeaways
- Eisai Co., Ltd. owns exclusive manufacturing rights for Dayvigo.
- Major pharmaceutical distributors supply the drug within regulated markets.
- Manufacturing occurs primarily in Japan and the U.S.
- Supply chain stability depends on Eisai’s production capacity and distributor networks.
- Market approval is limited to jurisdictions with regulatory clearance, affecting global supply.
FAQs
1. Can other companies produce Dayvigo under license?
No. Eisai holds exclusive rights; no licensed third-party manufacturers currently exist.
2. Are there regional differences in Dayvigo supply?
Yes. Supply depends on local regulatory approvals and distribution agreements; availability varies accordingly.
3. Is there a risk of shortages in Dayvigo supply?
Potentially, in events like manufacturing disruptions or regulatory delays, though Eisai has capacity expansion plans to mitigate this.
4. How does Eisai ensure quality in Dayvigo production?
The company adheres to FDA, PMDA, and EMA Good Manufacturing Practices (GMP) standards.
5. Will generic versions become available?
Not before patent exclusivity expires; currently, no generics are authorized.
References
[1] U.S. Food and Drug Administration. (2019). FDA approves Eisai’s DAYVIGO (lemborexant) for insomnia.
[2] Eisai Co., Ltd. (2022). Annual report and manufacturing disclosures.
[3] European Medicines Agency. (2020). Dayvigo approval documentation.
