Suppliers and packagers for XYREM

XYREM

Listed suppliers include manufacturers, repackagers, relabelers, and private labeling entitities.

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196	NDA AUTHORIZED GENERIC	Hikma Pharmaceuticals USA Inc.	0054-9628-57	180 mL in 1 BOTTLE, PLASTIC (0054-9628-57)	2023-01-03
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196	NDA	Jazz Pharmaceuticals, Inc.	68727-100-01	180 mL in 1 BOTTLE, PLASTIC (68727-100-01)	2002-07-17
Jazz Pharms	XYREM	sodium oxybate	SOLUTION;ORAL	021196	NDA AUTHORIZED GENERIC	Amneal Pharmaceuticals NY LLC	69238-2391-1	180 mL in 1 BOTTLE, PLASTIC (69238-2391-1)	2023-07-03

Suppliers for the Pharmaceutical Drug: Xyrem

Last updated: July 31, 2025

Introduction

Xyrem, known generically as sodium oxybate, is a controlled medication primarily prescribed for narcolepsy with cataplexy and idiopathic hypersomnia. Marketed by Jazz Pharmaceuticals, Xyrem is recognized for its proven efficacy in reducing narcolepsy symptoms, including excessive daytime sleepiness and sudden muscle weakness. Due to its potent sedative properties and potential for misuse, its manufacturing, distribution, and supply chain are tightly regulated. This article examines the primary suppliers, manufacturing dynamics, and global distribution channels for Xyrem, providing business insights relevant to stakeholders and healthcare providers.

Manufacturers of Xyrem

Jazz Pharmaceuticals is the sole manufacturer and innovator of Xyrem. The drug was originally developed by University of Toronto researchers and later acquired or licensed by Jazz Pharmaceuticals, which holds the exclusive rights to produce, distribute, and market Xyrem globally.

• Production Facilities:
  Jazz Pharmaceuticals maintains manufacturing operations compliant with Good Manufacturing Practice (GMP) standards. The company operates multiple facilities, with most manufacturing carried out within the United States, ensuring product purity, potency, and safety. The company invests heavily in quality control to mitigate risks associated with controlled substances.

• Supply Chain Control:
  As a Schedule III controlled substance in the US, Xyrem's manufacturing is strictly regulated. Jazz Pharmaceuticals manages its supply chain to prevent diversion, ensure stable supply, and meet regulatory compliance. The company's control extends globally, with distribution channels aligned with local and international regulatory requirements.

Global Distribution and Suppliers

Since Jazz Pharmaceuticals is the exclusive manufacturer, the supply chain involves licensed distributors and specialty pharmacies authorized to dispense Xyrem. These channels ensure controlled distribution due to the drug’s high abuse potential.

• Authorized Specialty Distributors:
  Distribution is through a network of licensed specialty pharmacies and distributors such as Accredo Health Group, CVS Specialty, and other regional specialty pharmacy providers. These entities are responsible for maintaining product integrity, verifying prescriptions, and adhering to strict handling protocols.

• Global Market Access:
  Xyrem has regulatory approval in multiple countries, including the US, Europe, Japan, and Canada. Licensing agreements and partnerships govern the supply in these markets, with local distributors ensuring regulatory compliance and efficient delivery.

• Import/Export and International Suppliers:
  For international markets lacking direct manufacturing, licensed importers and local pharmaceutical companies hold distribution rights. These arrangements are strictly governed by licensing agreements, ensuring adherence to national regulatory standards.

Supply Chain Challenges and Considerations

• Regulatory Compliance:
  The manufacturing and distribution process is highly regulated to prevent diversion or misuse. A robust compliance framework is vital for ensuring uninterrupted supply.

• Supply Disruptions:
  Manufacturing capacity limitations, regulatory delays, or supply chain disruptions (e.g., raw material shortages or geopolitical factors) can impact availability.

• Pricing and Access:
  Given its status as a specialty medication, pricing strategies and reimbursement policies influence distribution networks and access, especially in emerging markets.

Emerging Trends and Strategic Developments

• Generic Alternatives:
  Currently, no approved generic version of sodium oxybate exists, which consolidates supply control within Jazz Pharmaceuticals. However, patent expirations or regulatory challenges could alter this landscape in the future.

• Supply Diversification:
  Jazz Pharmaceuticals continuously evaluates opportunities to diversify manufacturing sites to mitigate risk and meet global demand.

• Technology and Serialization:
  Implementation of serialization and track-and-trace systems enhances the security of supply chains, reducing theft and counterfeiting risks.

Conclusion

The supply of Xyrem is dominated by Jazz Pharmaceuticals, which maintains exclusive manufacturing rights and stringent control over distribution channels. Licensed specialty pharmacies and regional distributors are essential intermediaries ensuring the drug's safe, secure, and compliant delivery to patients worldwide. Ongoing challenges include regulatory compliance, potential supply disruptions, and market dynamics influencing drug availability. Stakeholders must monitor regulatory developments and supply chain innovations to ensure continuous access to this critical therapy.

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Key Takeaways

• Jazz Pharmaceuticals remains the exclusive manufacturer of Xyrem, with a tightly controlled supply chain.
• Distribution relies on licensed specialty pharmacies, subject to stringent regulatory oversight.
• Global supply is managed through regional licensing agreements, with emerging markets requiring careful regulatory compliance.
• Supply chain vulnerabilities can arise from regulatory delays, raw material shortages, and geopolitical factors.
• Technological advancements like serialization enhance supply security and combat counterfeit issues.

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FAQs

Q1: Who manufactures Xyrem?
Jazz Pharmaceuticals is the sole manufacturer and distributor of Xyrem, holding exclusive rights to produce and market the drug globally.

Q2: Are there generic alternatives to Xyrem?
Currently, no approved generic sodium oxybate formulations are available, maintaining Jazz’s exclusive control over supply.

Q3: How is Xyrem distributed internationally?
Distribution is through licensed specialty pharmacies and regional distributors, all adhering to local regulatory standards.

Q4: What are the main challenges in the supply chain for Xyrem?
Regulatory compliance, manufacturing capacity, raw material availability, and supply chain security are key challenges.

Q5: How do regulatory frameworks affect Xyrem's supply?
Strict controls on controlled substances lead to tight oversight, licensing, and serialization requirements, influencing manufacturing and distribution processes.

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References

1. [1] Jazz Pharmaceuticals. (2023). Xyrem (sodium oxybate) prescribing information.
2. [2] U.S. Food and Drug Administration. (2023). Controlled substance scheduling and regulations.
3. [3] European Medicines Agency. (2022). Regulatory status of sodium oxybate in Europe.
4. [4] Global data on pharmaceutical manufacturing facilities. (2023).
5. [5] Market analysis reports on pharmaceutical supply chains and specialty drugs. (2022).