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Suppliers and packagers for generic pharmaceutical drug: alvimopan
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alvimopan
Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.
| Applicant | Tradename | Generic Name | Dosage | NDA | NDA/ANDA | Supplier | Package Code | Package | Marketing Start |
|---|---|---|---|---|---|---|---|---|---|
| Hikma | ALVIMOPAN | alvimopan | CAPSULE;ORAL | 217753 | ANDA | Hikma Pharmaceuticals USA Inc. | 0054-0668-82 | 6 BLISTER PACK in 1 CARTON (0054-0668-82) / 5 CAPSULE in 1 BLISTER PACK | 2024-02-06 |
| Hikma | ALVIMOPAN | alvimopan | CAPSULE;ORAL | 217753 | ANDA | Golden State Medical Supply, Inc. | 51407-870-33 | 5 BLISTER PACK in 1 CARTON (51407-870-33) / 6 CAPSULE in 1 BLISTER PACK | 2023-08-31 |
| Ph Health | ALVIMOPAN | alvimopan | CAPSULE;ORAL | 216843 | ANDA | ENDO USA, Inc. | 0254-3012-55 | 6 BLISTER PACK in 1 CARTON (0254-3012-55) / 5 CAPSULE in 1 BLISTER PACK | 2023-05-03 |
| Watson Labs Teva | ALVIMOPAN | alvimopan | CAPSULE;ORAL | 208295 | ANDA | Actavis Pharma, Inc. | 0591-2312-15 | 30 BLISTER PACK in 1 CARTON (0591-2312-15) / 1 CAPSULE in 1 BLISTER PACK (0591-2312-45) | 2020-12-01 |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >NDA/ANDA | >Supplier | >Package Code | >Package | >Marketing Start |
Suppliers for the Pharmaceutical Drug: Alvimopan
Introduction
Alvimopan is a peripherally acting μ-opioid receptor antagonist primarily prescribed to accelerate gastrointestinal recovery following partial large or small bowel surgeries. Its unique mechanism of action, selective peripheral μ-opioid receptor blockade, helps mitigate postoperative ileus without affecting central analgesia. With its approval by the U.S. Food and Drug Administration (FDA) in 2008, alvimopan has gained prominence in postoperative care protocols. The sourcing, manufacturing, and distribution channels for alvimopan involve specialized pharmaceutical suppliers, contract manufacturing organizations (CMOs), and distribution networks that ensure drug availability across global markets.
This analysis provides a comprehensive overview of primary suppliers for alvimopan, examining manufacturing companies, supply chain considerations, and market dynamics that influence the drug’s availability. Accurate sourcing is vital for pharmaceutical companies, healthcare providers, and supply chain stakeholders aiming to ensure uninterrupted access to this critical medication.
Manufacturers of Alvimopan
1. Eisai Co., Ltd.
Overview:
Eisai, a Japanese multinational pharmaceutical company, is the original developer and patent holder of alvimopan. Since its initial development, Eisai has been the primary manufacturer, overseeing global production and distribution rights, often under licensing agreements with other pharmaceutical companies.
Manufacturing Capabilities:
Eisai operates multiple manufacturing facilities globally, with specialized units dedicated to peptide-based and complex chemical synthesis essential for producing alvimopan’s molecular structure. The company's rigorous quality standards comply with Good Manufacturing Practices (GMP) to ensure drug safety and efficacy.
Supply Chain Role:
Eisai manages global distribution networks, primarily serving markets in North America, Europe, and Asia. Manufacturing plants are strategically located to facilitate timely supply and meet regional regulatory requirements.
2. Contract Manufacturing Organizations (CMOs)
Due to the complex synthesis and stringent quality standards, several CMOs are engaged by Eisai and other pharma entities to supplement manufacturing capacity. These partnerships expand supply options and mitigate risks associated with single-source dependency.
Notable CMOs for Alvimopan:
- Patheon (a Thermo Fisher Scientific company): Known for large-scale complex molecule manufacturing, Patheon has capabilities for peptide synthesis essential for alvimopan.
- Bachem: Specializes in peptide synthesis and contract manufacturing, offering high-purity active pharmaceutical ingredients (APIs) for central nervous system drugs like alvimopan.
- Samsung BioLogics: Engaged in biologics and peptide manufacturing, Samsung has capabilities that could support peptide drug production, though specific involvement in alvimopan manufacturing has not been publicly confirmed.
Note: While detailed CMO arrangements are proprietary, their involvement is critical for scaling production and ensuring supply continuity, especially amid global supply chain disruptions.
Distribution and Supply Chain Dynamics
Regional Suppliers and Distributors
-
United States:
The FDA-approved version of alvimopan is primarily supplied by Eisai Inc., the U.S. subsidiary of Eisai Co., Ltd. Following regulatory approvals, the company established robust distribution channels, including partnerships with major pharmaceutical distributors like McKesson, Cardinal Health, and AmerisourceBergen. -
European Markets:
In the European Union, alvimopan’s distribution depends on licensing agreements with regional pharmaceutical companies, given that regulatory approvals often differ from the U.S. FDA. Licenses granted to European distributors involve local manufacturing or importation through authorized channels, with supply managed by regional logistics providers. -
Asian Markets:
Eisai's home market and other Asian countries benefit from local manufacturing facilities or regional licensing partners, such as quality-assured CMOs. Eisai's extensive regional presence ensures supply security within Asia.
Supply Challenges and Market Dynamics
Supply chain stability for alvimopan hinges on manufacturing capacity, regulatory compliance, raw material availability, and global logistics. Peptide-based drugs like alvimodan demand high-precision synthesis processes, which can influence manufacturing schedules. Disruptions—such as those caused by global pandemics—can impact raw material procurement, production timelines, and distribution.
Additionally, patent protections or exclusivity periods influence the involvement of third-party suppliers. Once patents expire, biosimilar or generic manufacturers could enter the market, potentially increasing supply options.
Emerging Generic and Biosimilar Suppliers
While alvimopan remains under patent protection, the expiration timeline influences future supplier landscapes. The entry of biosimilars or generics can dramatically diversify supply sources, lower costs, and improve access. Monitoring patent statuses and regional regulatory decisions is imperative for stakeholders to anticipate market shifts.
Potential entrants include:
- Regional pharmaceutical firms specializing in peptide synthesis.
- Contract manufacturers prepared to scale production upon patent expiry.
Regulatory and Quality Assurance
Suppliers must adhere to strict GMP standards mandated by regulatory authorities such as the FDA, EMA, and PMDA. Eisai and contracted CMOs undergo rigorous audits and quality checks to ensure batch-to-batch consistency, purity, and compliance.
Supply chain transparency and traceability are crucial, especially amid recalls or quality issues. Companies often establish comprehensive supplier qualification programs, audits, and quality agreements to mitigate risks.
Conclusion
The supply landscape for alvimopan is predominantly controlled by Eisai Co., Ltd., leveraging a global manufacturing and distribution network rooted in high-quality peptide synthesis and complex chemical manufacturing. CMOs play a vital role in supplementing capacity, ensuring resilience against supply disruptions. Healthcare providers and stakeholders should monitor patent statuses, manufacturing capabilities, and regulatory environments to ensure ongoing access to alvimopan.
Key Takeaways
- Eisai Co., Ltd. remains the central supplier of alvimopan, with robust global manufacturing and distribution channels.
- Contract manufacturing organizations such as Patheon and Bachem are critical to scaling production and mitigating supply risks.
- The complexity of peptide synthesis necessitates high-quality GMP manufacturing, which constrains supply flexibility.
- Distribution is region-specific, with licensing agreements influencing market entry and availability.
- Future market dynamics will depend on patent expirations and the potential entry of biosimilars or generics, broadening supply options.
FAQs
1. Who are the primary manufacturers of alvimopan?
Eisai Co., Ltd. is the original manufacturer and primary supplier, often partnering with CMOs such as Patheon and Bachem for manufacturing support.
2. Are biosimilars or generics available for alvimopan?
As of now, alvimopan remains under patent protection, with biosimilar or generic versions not yet available. Market entry will depend on patent expiration and regulatory approvals.
3. What regions have approved alvimopan for clinical use?
The FDA in the United States has approved alvimopan. Approval status varies in Europe, Asia, and other regions based on regional regulatory agencies.
4. How is alvimopan supply chain secured?
Supply is secured through a combination of in-house manufacturing by Eisai and partnerships with CMOs, complemented by regional distribution agreements adhering to GMP standards.
5. What factors could impact future alvimopan supply?
Patent expiration, manufacturing capacity limitations, raw material availability, and regulatory changes are key factors influencing future supply potential.
Sources:
[1] FDA Drug Label for Alvimopan, 2008.
[2] Eisai Co., Ltd. Corporate Website and Product Portfolio.
[3] Contract Manufacturing Organization Capabilities Reports.
[4] European Medicines Agency (EMA) Approvals and Licensing information.
[5] Market Analysis of Peptide Synthesis and Complex Chemical Manufacturing Providers.
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