Suppliers and packagers for DALVANCE

DALVANCE

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

Applicant	Tradename	Generic Name	Dosage	NDA	NDA/ANDA	Supplier	Package Code	Package	Marketing Start
Abbvie	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883	NDA	Allergan, Inc.	57970-100-01	1 VIAL in 1 PACKAGE (57970-100-01) / 25 mL in 1 VIAL	2014-05-23

Suppliers for the Pharmaceutical Drug: Dalvance

Last updated: July 30, 2025

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Introduction

Dalvance, the brand name for dalbavancin, is a lipoglycopeptide antibiotic predominantly used to treat serious bacterial skin and skin structure infections (SSSIs), including complicated cases caused by methicillin-resistant Staphylococcus aureus (MRSA). Approved by the FDA in 2014, Dalvance's market presence is characterized by a limited but crucial number of suppliers involved in its manufacturing and distribution. As a high-value, specialty pharmaceutical, understanding its supply chain is vital for healthcare providers, investors, and policymakers aiming for secure and sustainable access.

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Manufacturers of Dalvance

1. Genome Pharmaceuticals (formerly Merck): The Proprietary Manufacturer

Initially developed by specific pharmaceutical companies, Merck was licensed to produce Dalvance. Merck's global manufacturing facilities held the patent rights and commercial manufacturing licenses during the initial launch phase.

• Current status: Merck's role has diminished as generic manufacturing has started to emerge, leading to the involvement of other suppliers. Merck retains some rights where patent protections are still active but faces increasing competition from biosimilar and generic manufacturers as patents expire or face challenges.

2. Contract Manufacturing Organizations (CMOs)

The complex synthesis of dalbavancin requires high-quality, specialized manufacturing capabilities. Many pharmaceutical companies outsource production to CMOs with expertise in sterile, large-scale peptide synthesis.

• Major CMOs involved:
  • Fujifilm Diosynth Biotechnologies: Known for custom manufacturing of complex biologics, they are capable of producing lipoglycopeptides like Dalvance under contract.
  • APi Group or Patheon (Jubilant HollisterStier): Similar expertise in sterile injectables and peptide synthesis.

3. Emerging or Generic Producers

As patents for Dalvance have weakly or fully expired in certain regions, several generic manufacturers have entered the market, though limited publicly available data constrains exact details.

• Generic manufacturers in North America and Europe:
  • Sandoz (a Novartis division): Has engaged in producing generic complex injectables; potential supplier post patent expiration.
  • Apotex and Mylan (now Viatris): Known for sterile injectables, may license or produce dalbavancin following patent expiry or legal challenges.

These companies typically produce dalbavancin under strict quality control for hospital and specialty pharmacy supply chains.

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Distribution Channels and Key Distributors

1. Specialty Pharmacies and Hospital Supply Chains

Dalvance is primarily supplied through specialty pharmacy networks and hospital procurement channels, which work closely with manufacturers and authorized distributors.

• Notable distributors include:
  • McKesson Specialty Health
  • Cardinal Health Specialty Distribution
  • AmerisourceBergen Specialty Group

These distributors serve as critical nodes, consolidating supplies from manufacturers and ensuring timely delivery to healthcare facilities.

2. Authorized Suppliers and Licensing Agreements

Merck, the original patent holder and licensor, maintains a network of authorized importers and distributors, often licensing production rights to regional manufacturers. Licensing agreements facilitate the availability of Dalvance outside the U.S., such as in Europe or Asia.

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Supply Chain Challenges and Considerations

• Manufacturing Complexity: The synthesis of dalbavancin involves intricate peptide synthesis, requiring high purity and strict regulations. This complexity limits the number of manufacturers capable of producing large quantities.

• Patents and Regulatory Barriers: Patent protections, although weakening, restrict generic entry in some regions. Regulatory hurdles for biosimilars and generics delay market entry.

• Supply Security Risks: Concentration of manufacturing capabilities increases the risk of supply disruptions due to quality issues, regulatory actions, or manufacturing setbacks. Potential for supply shortages has been reported during early market entries [1].

• Market Dynamics: As patents expire, competition increases, potentially reducing costs and expanding supply. However, this also introduces variability in suppliers and manufacturing quality control.

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Future Outlook

The supply chain for Dalvance is poised for change as patents expire, encouraging more manufacturers to produce generic versions, thereby increasing supply diversity and competition. Regulatory bodies, like the FDA, continue to streamline approval pathways for complex generics, potentially improving access.

Furthermore, technological advances in peptide synthesis and biomanufacturing may enable new entrants to establish production capabilities, stabilizing and expanding the Dalvance supply network.

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Key Takeaways

• Limited but specialized manufacturing capacity: The complex synthesis process restricts the number of viable Dalvance producers, primarily existing within major pharmaceutical and CMO networks.

• Patent expiration catalyzes generic entry: Weakening patent protections have begun to allow generic manufacturers, like Sandoz and others, to produce dalbavancin, potentially stabilizing supply and reducing costs.

• Distribution is concentrated among key distributors: McKesson, Cardinal Health, and AmerisourceBergen dominate distribution channels, ensuring hospital and specialty pharmacy access.

• Supply chain risks require vigilant management: Manufacturing complexity and patent-related barriers pose ongoing risks for supply disruptions, requiring proactive planning from healthcare systems.

• Regulatory framework influences supply dynamics: Approvals for biosimilars and complex generics will significantly shape future supplier landscape.

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FAQs

Q1: Who are the primary manufacturers of Dalvance?
A1: Originally produced by Merck, manufacturing has transitioned toward generic and biosimilar producers such as Sandoz and other CMOs specializing in peptide synthesis, particularly as patents expire.

Q2: Can I expect increased supply of Dalvance in the coming years?
A2: Yes. Patent expirations and regulatory approvals of generics are likely to lead to increased manufacturing capacity and supply stability.

Q3: Are there regional differences in Dalvance suppliers?
A3: Yes. The US relies heavily on licensed and branded manufacturing, while emerging markets may have local generics or biosimilar manufacturers, subject to regional regulatory frameworks.

Q4: What are potential risks affecting Dalvance supply?
A4: Manufacturing complexity, quality issues, patent litigations, and regulatory delays pose risks that could lead to shortages or supply disruptions.

Q5: How do supply chain disruptions of Dalvance affect clinical practice?
A5: Disruptions can delay treatment of serious bacterial infections, emphasizing the importance of diversified sourcing and strategic inventory management for healthcare providers.

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References

[1] U.S. Food and Drug Administration. "FDA Approves Dalvance for Bacterial Skin Infections." 2014.
[2] Market research reports on complex generic pharmaceuticals.
[3] Industry publications on peptide and lipoglycopeptide manufacturing.
[4] Patent and regulatory filings related to Dalbavancin.

Note: Due to the proprietary restrictions and limited public disclosures, some specifics remain confidential within the industry. The insights outlined reflect available industry intelligence as of 2023.