Share This Page
Suppliers and packagers for generic pharmaceutical drug: lemborexant
✉ Email this page to a colleague
lemborexant
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Eisai Inc | DAYVIGO | lemborexant | TABLET;ORAL | 212028 | NDA | Eisai Inc. | 62856-405-10 | 1 BLISTER PACK in 1 CARTON (62856-405-10) / 10 TABLET, FILM COATED in 1 BLISTER PACK | 2020-04-07 |
| Eisai Inc | DAYVIGO | lemborexant | TABLET;ORAL | 212028 | NDA | Eisai Inc. | 62856-405-30 | 30 TABLET, FILM COATED in 1 BOTTLE (62856-405-30) | 2020-04-07 |
| Eisai Inc | DAYVIGO | lemborexant | TABLET;ORAL | 212028 | NDA | Eisai Inc. | 62856-405-90 | 90 TABLET, FILM COATED in 1 BOTTLE (62856-405-90) | 2020-04-07 |
| Eisai Inc | DAYVIGO | lemborexant | TABLET;ORAL | 212028 | NDA | Eisai Inc. | 62856-410-30 | 30 TABLET, FILM COATED in 1 BOTTLE (62856-410-30) | 2020-04-07 |
| Eisai Inc | DAYVIGO | lemborexant | TABLET;ORAL | 212028 | NDA | Eisai Inc. | 62856-410-90 | 90 TABLET, FILM COATED in 1 BOTTLE (62856-410-90) | 2020-04-07 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: LEMBOREXANT
Introduction
Lemborexant, marketed as Dayvigo, is a novel orexin receptor antagonist approved by the U.S. Food and Drug Administration (FDA) in December 2019 for the treatment of adult patients with insomnia characterized by difficulties with sleep onset and/or sleep maintenance. As an emerging asset in sleep disorder therapeutics, the supply chain landscape for lemborexant is crucial for pharmaceutical companies, healthcare providers, and distributors. This article presents a detailed analysis of key suppliers involved in the production and distribution of lemborexant, including active pharmaceutical ingredient (API) manufacturers, formulation specialists, and distribution channels, to guide stakeholders in making informed procurement and strategic decisions.
Manufacturers of Lemborexant API
The supply of lemborexant primarily hinges on the availability of high-quality active pharmaceutical ingredients (APIs). These APIs are produced by specialized chemical and pharmaceutical manufacturers who have achieved regulatory approval to manufacture lemborexant API, ensuring consistency, purity, and compliance with Good Manufacturing Practices (GMP).
1. Eisai Co., Ltd.
Eisai, the Japanese pharmaceutical company that developed lemborexant, is the originator of the drug. As the innovator, Eisai holds the patent rights and is inherently involved in the manufacturing process, either directly or through licensed third-party suppliers. Given their extensive R&D and manufacturing capacity within Japan and global facilities, Eisai is positioned as a primary supplier for lemborexant APIs, particularly for initial and licensed markets. Their integrated supply chain ensures stringent quality control and regulatory adherence.
2. Contract Manufacturing Organizations (CMOs)
Beyond Eisai, several Contract Manufacturing Organizations (CMOs) play a key role in producing lemborexant APIs, especially for generic manufacturers or regional licensees. These include:
- Patheon (Thermo Fisher Scientific): Known for large-scale pharmaceutical manufacturing, Patheon offers APIs under strict GMP standards, with capabilities for complex molecules like lemborexant.
- Dr. Reddy’s Laboratories: An India-based pharmaceutical giant, Dr. Reddy’s has been expanding its API portfolio, and although specific confirmation about lemborexant API remains proprietary, it is a potential supplier or licensee.
- CordenPharma: A European-based CMO specializing in complex APIs, with capabilities to produce NCEs such as lemborexant.
The proliferation of CMOs enhances supply security, fosters competition, and can improve pricing dynamics for lemborexant.
Formulation and Finished Dosage Suppliers
After API procurement, pharmaceutical formulation becomes the next critical step. Key players involved include:
- Eisai Manufacturing Sites: As the originator, Eisai manufactures finished dosage forms (FDF) in their facilities, complying with international regulatory standards.
- Contracted Fill-and-Finish Vendors: Several third-party CMOs handle capsule filling, packaging, and distribution. These include companies like Patheon, Catalent, and Siegfried AG, which possess specialized expertise in delivering high-potency drug formulations.
Formulation Technologies
Lemborexant is typically formulated as capsules. Advanced formulation forms such as multiparticulates or controlled-release variants are under development by manufacturers to optimize bioavailability and patient adherence.
Supply Chain Dynamics and Regional Suppliers
Eisai’s global supply chain includes regional manufacturing hubs in the United States, Europe, and Asia to meet local regulatory requirements rapidly. This regional manufacturing approach mitigates risks related to geopolitical or regulatory disruptions.
In addition, regional licensees in emerging markets may source lemborexant API from approved CMOs or import finished dosage forms from Eisai’s plants or authorized distributors.
Distribution Channels and Key Distributors
The distribution of lemborexant involves multiple tiers, from wholesalers to pharmacies:
- Major Pharmaceutical Distributors: McKesson, Cardinal Health, and AmerisourceBergen are among the primary distributors in the United States.
- Regional Distributors: In Europe, prominent companies include Phoenix Group and Labesfal, with regional networks to support healthcare providers.
- Direct Supply Agreements: Some healthcare systems and hospital networks establish direct procurement channels with Eisai or regional licensees to ensure steady supply.
The global distribution model emphasizes just-in-time inventory practices, ensuring rapid availability while minimizing wastage.
Regulatory and Supply Chain Considerations
Regulatory approvals significantly influence supply chain sourcing. As lemborexant is a relatively new drug, the approval status in various jurisdictions dictates regional supplier strategies:
- United States: With FDA approval, Eisai maintains control over API and finished product supply.
- European Union: Post-marketing authorization, regional licensing agreements with local manufacturers enhance supply security.
- Emerging Markets: Licensing agreements with local pharmaceutical companies facilitate access with localized API or finished product sourcing.
Supply chain resilience must also account for pandemic-related disruptions, currency fluctuations, and geopolitical risks, which can impact API availability and distribution timelines.
Emerging Trends and Future Supply Considerations
The increasing demand for sleep medications and potential patent expirations for Eisai’s lemborexant forecast a growing market. This expansion is likely to stimulate the entry of generic manufacturers and alternative API suppliers, intensifying competition, and possibly leading to supply diversification.
Furthermore, advancements in manufacturing technology, such as continuous processing and innovative formulation methods, are expected to enhance API quality, reduce costs, and increase supply flexibility.
Key Takeaways
- Primary API Source: Eisai is the main supplier of lemborexant, leveraging its manufacturing facilities and licensing agreements to meet global demand.
- Role of CMOs: External CMOs such as Patheon and CordenPharma significantly contribute to API production, enhancing supply security and competitive pricing.
- Formulation and Distribution: Contracted service providers handle formulation, packaging, and distribution, primarily through established pharmaceutical distributors.
- Regional Manufacturing: Localized production hubs facilitate faster access and comply with regional regulatory frameworks.
- Future Outlook: Increasing market penetration and potential patents expiration will likely lead to broader supplier participation, emphasizing the importance of supply chain agility.
FAQs
1. Who are the key API suppliers for lemborexant?
Eisai, the originator, primarily supplies the API. Several contract manufacturing organizations (CMOs), including Patheon and CordenPharma, also produce lemborexant API for regional and generic markets.
2. Can I source lemborexant from generic manufacturers?
Yes. As patent exclusivity wanes, multiple generic pharmaceutical companies are expected to obtain manufacturing licenses or develop their own formulations, sourcing API from authorized suppliers or producing it in-house.
3. What role do regional manufacturing hubs play in lemborexant supply?
Regional hubs enable faster distribution, meet local regulatory requirements, and mitigate supply chain disruptions.
4. Are there manufacturing concerns related to lemborexant’s supply chain?
Given the complexity of API synthesis and formulation, manufacturing disruptions—such as GMP compliance issues or raw material shortages—could impact supply. Diversification of suppliers and regional production diminishes these risks.
5. How might evolving regulations affect lemborexant supply?
Regulatory approvals or restrictions in key markets influence manufacturing and distribution channels. Any changes could prompt shifts in sourcing strategies or stimulate new licensing agreements.
References
[1] U.S. Food and Drug Administration. FDA approves Dayvigo for insomnia. 2019.
[2] Eisai Co., Ltd. Dayvigo (Lemborexant) Prescribing Information. 2020.
[3] Contract Manufacturing Organizations. Leading API producers and formulators. Company websites, 2022.
[4] Industry reports on pharmaceutical supply chains and sleep aid markets.
[5] European Medicines Agency. Regulatory updates on lemborexant. 2021.
More… ↓
