Suppliers and packagers for qutenza

qutenza

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395	NDA	Averitas Pharma Inc	72512-928-01	1 KIT in 1 CARTON (72512-928-01) * 1 POUCH in 1 CARTON (72512-920-00) / 1 PATCH in 1 POUCH / 179 mg in 1 PATCH * 50 g in 1 TUBE	2018-10-30
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395	NDA	Averitas Pharma Inc	72512-929-01	1 KIT in 1 CARTON (72512-929-01) * 2 POUCH in 1 CARTON (72512-920-01) / 1 PATCH in 1 POUCH / 179 mg in 1 PATCH * 50 g in 1 TUBE	2018-10-30
Averitas	QUTENZA	capsaicin	PATCH;TOPICAL	022395	NDA	Averitas Pharma Inc	72512-930-01	1 KIT in 1 CARTON (72512-930-01) * 4 POUCH in 1 CARTON (72512-920-02) / 1 PATCH in 1 POUCH / 179 mg in 1 PATCH * 3 TUBE in 1 CARTON / 50 g in 1 TUBE	2021-03-25

Suppliers for the Pharmaceutical Drug: QUTENZA

Last updated: July 30, 2025

Introduction

QUTENZA (capsaicin) topical system is a high-concentration capsaicin patch designed for the management of neuropathic pain, including postherpetic neuralgia (PHN). Approved by regulatory agencies like the FDA and EMA, QUTENZA represents a significant advancement in pain management therapies. For pharmaceutical companies, healthcare providers, and supply chain stakeholders, understanding the supplier landscape for QUTENZA is vital for ensuring product availability, negotiating procurement, and managing market competition.

This comprehensive analysis details the key suppliers, manufacturing landscape, distribution channels, and strategic considerations pertinent to QUTENZA. It aims to inform industry professionals about the current sourcing environment, highlighting opportunities and challenges within this niche pharmaceutical segment.

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Manufacturers and Primary Suppliers

1. NeurogesX (Now part of Kala Pharmaceuticals)

Originally developed by NeurogesX Inc., QUTENZA's primary manufacturing seamless patch was initially supplied by this U.S.-based biotech. Following NeurogesX's acquisition by Kala Pharmaceuticals in 2019, the manufacturing rights and associated supply chain have transitioned under Kala’s operational scope.

Contribution:

• Developed and commercialized the original capsaicin patch.
• Ensured initial supply to North American markets.

Current Status:
Kala Pharmaceuticals continues to market QUTENZA, maintaining the manufacturing and distribution rights. The company invests in quality assurance to meet regulatory standards for the drug’s complex patch delivery system.

2. Contract Manufacturing Organizations (CMOs)

Given the complexity of manufacturing a transdermal patch with high-concentration capsaicin (8%), several CMOs are contracted to support different aspects:

• Formulation and Patch Production:
  Specialized manufacturers with expertise in transdermal patch technology and controlled-release systems are utilized. These CMOs are responsible for the precise formulation, encapsulation, and ensuring skin adhesion properties.

• Packaging and Final Assembly:
  Packaging involves sterile conditions, secure blister packs, and tamper-evident features, handled by niche pharmaceutical packaging firms.

Note:
The actual names of these CMOs typically remain undisclosed due to confidentiality agreements, but major contract manufacturing players in transdermal systems such as Catalent, Recipharm, and Wacker are potential candidates.

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Distribution and Supply Chain

3. Geographic Suppliers and Distribution Channels

QUTENZA's supply chain involves a multi-tiered distribution network:

• Regional Distributors:
  Licensed pharmaceutical distributors and specialty pharmacies serve as intermediaries ensuring product availability at healthcare facilities, clinics, and pain management centers.

• Direct Supply to Hospitals/Clinics:
  Larger hospital networks or healthcare providers may establish direct procurement agreements to streamline supply.

• Pharmacist Dispensing:
  Specialty pharmacies play a pivotal role in outpatient distribution, especially since QUTENZA is typically prescribed for chronic pain management.

Regulatory & Logistics Considerations:
Distribution compliance with temperature controls, handling protocols for sterile patches, and adherence to country-specific regulatory approvals are critical in maintaining product integrity.

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Legal and Patent Landscape

While the primary patent protecting QUTENZA has expired or is nearing expiry in multiple jurisdictions, new formulations or device innovations could influence the supply chain. Patent expiration opens pathways for generic players, potentially providing alternative suppliers, though currently, the high-cost niche limits market entrants.

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Emerging Supplier Trends and Strategic Considerations

4. Potential Entries by Generics and Biosimilars

As patent protections expire, generic manufacturers may seek approval, increasing supplier diversity. The entrance of generics could reduce costs but also complicate supply chain management for branded QUTENZA.

5. Supply Chain Challenges

The complexity inherent in transdermal patch production includes:

• Ensuring high-purity capsaicin formulation consistency
• Maintaining sterile manufacturing environments
• Scaling production without compromising quality

Disruptions in raw material supply, especially for capsaicin derived from chili peppers or synthetic sources, could impact overall availability.

6. Alternative Suppliers and Risk Mitigation

Stakeholders should monitor regulatory filings, product approvals, and partnerships in regions like Europe, North America, and Asia. Developing relationships with multiple suppliers mitigates risks of shortages resulting from manufacturing setbacks or geopolitical issues.

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Market Dynamics and Pricing

The limited number of suppliers and complex manufacturing process contribute to QUTENZA’s premium pricing. As competition increases, especially with potential generics, suppliers may need to optimize manufacturing costs without compromising quality. Strategic alliances, contractual negotiations, and innovative supply chain models will influence pricing and availability moving forward.

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Regulatory Impact on Supply Chain

Ongoing regulatory surveillance influences supplier behavior. Post-approval, manufacturers must adhere to stringent quality controls, which can affect production timelines. Variations in regulatory standards between regions may necessitate localized suppliers or manufacturing facilities to ensure compliance and uninterrupted supply.

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Conclusion

The supply landscape for QUTENZA is characterized by a small number of specialized manufacturers and a complex, regulated distribution network. Current primary manufacturing responsibilities reside with Kala Pharmaceuticals, supported by contracted CMOs with expertise in transdermal delivery systems. Distribution channels are diverse, involving specialty pharmacies, hospitals, and regional intermediaries.

Anticipated expiration of patents and the potential rise of generic competitors will influence supplier diversity, pricing strategies, and market competition. Stakeholders must prioritize risk mitigation through diversified supplier relationships, rigorous quality controls, and proactive regulatory engagement.

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Key Takeaways

• Main Manufacturers: Currently led by Kala Pharmaceuticals, supported by specialized CMOs in formulation, patch production, and packaging.
• Supply Chain Complexity: Ensures product quality and regulatory compliance but poses risks that require diversified sourcing strategies.
• Emerging Competition: Patent expirations could introduce generics, potentially altering supplier dynamics and pricing.
• Regulatory Navigation: Compliance affects manufacturing and distribution; regional differences necessitate adaptable supply chain models.
• Strategic Focus: Building alliances with multiple suppliers, investing in quality assurance, and monitoring patent landscapes are vital to secure supply continuity.

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FAQs

1. Who are the primary suppliers of QUTENZA in the United States?
Kala Pharmaceuticals is the primary supplier, managing manufacturing and distribution, supported by contracted CMOs specializing in transdermal patches.

2. Can other companies produce generic versions of QUTENZA?
Yes, as patents expire, generic manufacturers may develop bioequivalent versions, potentially increasing supply options and reducing costs.

3. What are the risks associated with QUTENZA supply chain disruptions?
Risks include raw material shortages, manufacturing delays, quality compliance issues, and geopolitical or regulatory hurdles affecting distribution.

4. How does patent status influence supplier diversity?
Patent expirations open markets for generics, increasing supply options but may initially impact brand suppliers' control over production and pricing.

5. Are there regional differences in QUTENZA suppliers?
Yes. While North America is primarily supplied by Kala Pharmaceuticals, European and Asian markets may involve local licensed manufacturers and distributors adhering to regional regulatory standards.

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Sources:

1. FDA Drug Database, QUTENZA product details.
2. Kala Pharmaceuticals' official disclosures and press releases.
3. Industry reports on transdermal drug manufacturing.
4. Patent disclosures and regulatory filings.