Suppliers and packagers for XATMEP

XATMEP

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Azurity	XATMEP	methotrexate sodium	SOLUTION;ORAL	208400	NDA	Azurity Pharmaceuticals, Inc.	52652-2001-1	120 mL in 1 BOTTLE (52652-2001-1)	2017-05-01
Azurity	XATMEP	methotrexate sodium	SOLUTION;ORAL	208400	NDA	Azurity Pharmaceuticals, Inc.	52652-2001-6	60 mL in 1 BOTTLE (52652-2001-6)	2017-05-01

Last updated: July 29, 2025

ppliers for the Pharmaceutical Drug: Xatmep

Introduction

Xatmep, the oral suspension formulation of methotrexate, functions as a critical medication in the management of certain cancers and autoimmune diseases such as rheumatoid arthritis and psoriasis. Its importance in clinical treatments has elevated the necessity to understand its supply chain, especially given the vulnerability of pharmaceutical manufacturing and distribution complexities. This report provides a comprehensive analysis of current suppliers for Xatmep, exploring manufacturing sources, distribution channels, and strategic implications for stakeholders.

Manufacturers and Original Suppliers of Xatmep

Xatmep is marketed by Rapport Therapeutics, which acquired rights from Eli Lilly and Company following the latter’s transition out of the methotrexate market. Its formulation, specifically as an oral liquid, was developed to facilitate easier administration, particularly in pediatric populations. Eli Lilly initially developed and distributed methotrexate products, including injectable and oral forms, while Rapport now primarily handles the oral suspension specifically branded as Xatmep within the United States and select international markets.

Generic and Biosimilar Manufacturers

While Xatmep is a branded drug, the methotrexate molecule itself has numerous generic manufacturers. These generics typically produce tablets of methotrexate but are increasingly developing formulations similar to Xatmep’s oral suspension. Notably, key suppliers for generic methotrexate oral solutions include companies such as Sandoz, Mylan (now part of Viatris), and Teva Pharmaceuticals. Their production capabilities span multiple geographies, ensuring broad availability and competitive pricing.

However, generic production of liquid formulations mirrors the complexities faced in branded manufacturing, such as maintaining stability, purity, and consistent dosing in suspension forms. Not all generic manufacturers produce liquid methotrexate; the focus remains primarily on solid tablet forms, with fewer suppliers offering liquid equivalents due to manufacturing challenges. Currently, Sandoz and Viatris have announced the production of liquid methotrexate formulations, positioning them as potential suppliers of Xatmep-like products if regulatory approval is obtained.

Supply Chain and Distribution Channels

The drug’s distribution primarily operates through a network of wholesale distributors, hospital pharmacies, and specialty pharmacies. Major pharmaceutical distributors such as McKesson, AmerisourceBergen, and Cardinal Health serve as backbone suppliers, ensuring broad access across hospitals and retail pharmacies. The supply chain’s robustness is vital given methotrexate's narrow therapeutic window and the critical need for consistency.

For healthcare providers and patients, distribution is often managed through specialty pharmacy channels, especially for pediatric populations or patients with specific dosing requirements. These channels handle the delicate logistics associated with liquid formulations, such as stability and temperature control.

Regulatory and Production Challenges

Manufacturing Xatmep poses distinctive challenges, including maintaining formulation stability, preventing microbial contamination, and ensuring uniform dosing. The UK’s Medicines and Healthcare products Regulatory Agency (MHRA), the FDA, and other authorities impose strict quality controls that impact supply. Disruptions, such as raw material shortages or manufacturing delays, can hinder the supply chain, emphasizing the importance of diversified supplier networks.

Global Supply Considerations

While the majority of Xatmep’s supply is domestically produced within the U.S., international demand necessitates collaborations and licensing agreements with global manufacturers. Strategic alliances with manufacturing hubs in India and Europe could mitigate risks associated with geographic or political disruptions.
Moreover, the ongoing global focus on pharmaceutical manufacturing resilience, especially post-pandemic, encourages companies to expand their supplier base for niche drugs like Xatmep.

Emerging Suppliers and Future Outlook

Given the patent expiry and increasing generic interest in methotrexate formulations, new entrants are poised to disrupt the supply landscape. Regulatory approvals for generic liquid methotrexate could introduce multiple suppliers into the market, increasing competition, reducing prices, and improving supply security. Furthermore, biosimilar development for injectable methotrexate indicates a broader industry push toward alternative formulations, which may influence the oral suspension segment in the future.

Implications for Stakeholders

For healthcare providers, understanding supplier diversification and quality assurance is critical for uninterrupted patient access. Manufacturers must navigate complex regulatory landscapes and ensure manufacturing scalability to meet rising demand. Payers and insurers should monitor supply chain stability to manage coverage policies effectively.

Key Takeaways

• Major supplier: Rapport Therapeutics holds the marketing rights for Xatmep, with Eli Lilly establishing the initial formulation.
• Generic landscape: Companies like Sandoz and Viatris are potential producers of liquid methotrexate formulations, though current liquid-specific manufacturing remains limited.
• Distribution network: Large wholesalers and specialty pharmacies form the backbone of Xatmep’s distribution, particularly for pediatric and outpatient settings.
• Supply chain risks: Raw material shortages, manufacturing delays, and regulatory hurdles can impact availability, highlighting the need for diversified supplier relationships.
• Market evolution: Increasing generic and biosimilar entries will likely enhance supply security and market competition, benefiting stakeholders across the board.

Conclusion

The supply landscape for Xatmep involves a combination of original manufacturing by Rapport Therapeutics, with potential contributions from generic players in the methotrexate segment. Maintaining a resilient supply chain depends on strategic supplier diversification, adherence to regulatory standards, and proactive management of manufacturing challenges. As the market for methotrexate formulations continues to evolve, stakeholders must stay vigilant regarding emerging suppliers and regulatory developments to ensure consistent patient access.

FAQs

1. Who are the primary manufacturers of Xatmep?
   Rapport Therapeutics markets Xatmep, which was developed originally by Eli Lilly. Generic manufacturers, such as Sandoz and Viatris, are developing comparable liquid methotrexate formulations, potentially serving as suppliers.

2. Are there alternative suppliers for liquid methotrexate similar to Xatmep?
   Yes. Companies like Sandoz and Viatris are expected to produce liquid methotrexate, though regulatory approval and market availability may vary.

3. What are the main supply chain risks for Xatmep?
   Raw material shortages, manufacturing delays, regulatory compliance issues, and disruptions in global logistics pose significant risks to Xatmep’s supply continuity.

4. How does regulation impact the supply of Xatmep?
   Stringent FDA and international regulatory standards require rigorous quality control, which can delay manufacturing approvals and impact supply if not strictly maintained.

5. What is the future outlook for Xatmep’s supply chain?
   The increasing interest in generic and biosimilar methotrexate formulations is anticipated to diversify the supplier base, improve resilience, and potentially reduce costs. Effective management of manufacturing and regulatory challenges will be critical for sustained supply.

References
[1] Eli Lilly and Company. Product information and development pipeline.
[2] Rapport Therapeutics website and press releases.
[3] Sandoz product portfolio and announced developments in liquid methotrexate formulations.
[4] FDA guidelines on methotrexate manufacturing and quality standards.
[5] Market analysis reports on generic and biosimilar methotrexate supply chain dynamics.