DALBAVANCIN HYDROCHLORIDE - Generic Drug Details

What are the generic drug sources for dalbavancin hydrochloride and what is the scope of freedom to operate?

Dalbavancin hydrochloride is the generic ingredient in two branded drugs marketed by Fresenius Kabi Usa, Teva Pharms Inc, and Abbvie, and is included in three NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

Dalbavancin hydrochloride has fifty-eight patent family members in twenty countries.

Three suppliers are listed for this compound.

Summary for DALBAVANCIN HYDROCHLORIDE

International Patents:	58
US Patents:	1
Tradenames:	2
Applicants:	3
NDAs:	3
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	26
What excipients (inactive ingredients) are in DALBAVANCIN HYDROCHLORIDE?	DALBAVANCIN HYDROCHLORIDE excipients list
DailyMed Link:	DALBAVANCIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DALBAVANCIN HYDROCHLORIDE

Identify potential brand extensions & 505(b)(2) entrants

Sponsor	Phase
St. Jude Children's Research Hospital	PHASE1
University of Colorado, Denver	PHASE4
Congressionally Directed Medical Research Programs	PHASE4

See all DALBAVANCIN HYDROCHLORIDE clinical trials

Pharmacology for DALBAVANCIN HYDROCHLORIDE

Drug Class

Lipoglycopeptide Antibacterial

Anatomical Therapeutic Chemical (ATC) Classes for DALBAVANCIN HYDROCHLORIDE

J01XA	Glycopeptide antibacterials
J01X	OTHER ANTIBACTERIALS
J01	ANTIBACTERIALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

Paragraph IV (Patent) Challenges for DALBAVANCIN HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
DALVANCE	Powder For Injection	dalbavancin hydrochloride	500 mg/vial	021883	3	2023-05-23

US Patents and Regulatory Information for DALBAVANCIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Fresenius Kabi Usa	DALBAVANCIN HYDROCHLORIDE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	217591-001	Nov 10, 2025	AP	RX	No	No
Abbvie	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014	AP	RX	Yes	Yes
Teva Pharms Inc	DALBAVANCIN HYDROCHLORIDE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	219465-001	Oct 23, 2025	AP	RX	No	No

Expired US Patents for DALBAVANCIN HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014
Abbvie	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014
Abbvie	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014

International Patents for DALBAVANCIN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
Israel	230875
Australia	2003299561	COMPOSITIONS AND METHODS FOR TREATING BACTERIAL INFECTIONS WITH PROTEIN-DALBAVANCIN COMPLEXES
Hungary	E041133
New Zealand	550053	Dalbavancin compositions for treatment of bacterial infections

Market Dynamics and Financial Trajectory for Dalbavancin Hydrochloride

Last updated: July 29, 2025

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Introduction

Dalbavancin hydrochloride, a semi-synthetic lipoglycopeptide antibiotic, is formulated primarily for the treatment of acute bacterial skin and skin structure infections (ABSSSI) caused by Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). Approved by the U.S. Food and Drug Administration (FDA) in 2014 under the brand name Dalvance, its distinctive pharmacokinetics and clinical advantages have positioned it uniquely within the infectious disease treatment landscape. This comprehensive analysis explores the evolving market dynamics and financial trajectory of dalbavancin hydrochloride, considering current market trends, competitive landscape, regulatory factors, and forecasted growth.

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Market Overview and Demand Drivers

Prevalence of ABSSSI and Antibiotic Resistance

The rising incidence of ABSSSI globally significantly propels demand for effective antibiotics like dalbavancin. According to the CDC, skin infections account for approximately 3.2 million outpatient visits annually in the U.S. alone, with MRSA responsible for a substantial proportion of these cases. The escalation of antibiotic-resistant strains intensifies the need for potent agents with efficacy against multidrug-resistant Gram-positive bacteria, underpinning dalbavancin’s market relevance.

Advantages of Dalbavancin Hydrochloride

Dalbavancin’s pharmacokinetic profile enables prolonged half-life (~14 days), allowing for single-dose or weekly dosing regimens, which markedly improve patient compliance and reduce hospitalization costs. Its administration sustainability makes it particularly attractive for outpatient parenteral antimicrobial therapy (OPAT), aligning with healthcare systems' shift towards outpatient management, thereby expanding its market potential.

Regulatory and Clinical Adoption Trends

Post-approval, dalbavancin has garnered approval in multiple jurisdictions, including the European Medicines Agency (EMA) and several Asian regulatory bodies. Clinical trials substantiate its non-inferiority to traditional therapies like vancomycin, with some studies indicating superior patient adherence and lower treatment failure rates. Growing clinician familiarity and confidence foster broader adoption, further influencing market dynamics.

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Market Segmentation and Competitive Landscape

Key Segments

• Hospital and inpatient settings: Dalbavancin initially targeted hospital-acquired infections but is increasingly used in outpatient settings due to its dosing convenience.

• Outpatient and home-based care: The shift toward home intravenous therapy bolsters dalbavancin’s utilization, driven by the COVID-19 pandemic’s impact on hospital resources and the demand for outpatient solutions.

Competitive Environment

Dalbavancin faces competition from established antibiotics such as vancomycin, linezolid, and newer agents like oritavancin, another lipoglycopeptide with similar dosing advantages. Although traditional antibiotics have extensive spectra and formulary integration, dalbavancin’s ease of administration and dosing schedule offer competitive differentiation.

Emerging pipeline agents and generic formulations could influence future dynamics, but currently, dalbavancin maintains a niche as a “single-dose” potent therapy with proven clinical efficacy.

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Pricing, Reimbursement, and Market Penetration

Pricing Strategies

Dalbavancin’s premium price point reflects its novel formulation and convenience benefits. The drug’s pricing varies across markets, often ranging from $3,000 to $5,000 per dose in the U.S., which can be offset by reduced hospitalization costs and outpatient management efficiency.

Reimbursement Trends

Reimbursement landscapes are evolving, with insurers increasingly recognizing the cost-saving potential of outpatient administration. Value-based care initiatives incentivize treatments that reduce hospital stay durations, positively impacting dalbavancin’s adoption and sales.

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Regulatory and Legal Environment

Regulatory approval milestones across regions extend dalbavancin's market reach. However, patent statuses influence market exclusivity, with patents expiring in some jurisdictions by mid-2020s, opening avenues for generic competition that could dilute pricing and margins.

Legal cases surrounding patent rights and formulation exclusivities also influence market entry strategies and investment perspectives.

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Financial Trajectory and Future Growth Prospects

Historical Performance

Since its launch, dalbavancin has exhibited steady adoption in hospital and outpatient settings, with sales primarily driven by the U.S. market. Market penetration remains partial, constrained by pricing and clinician familiarity, but the outlook remains optimistic given the drug's clinical and operational advantages.

Forecasting Future Revenue

Industry analysts project a compound annual growth rate (CAGR) of approximately 8-10% from 2023 to 2030, fueled by increasing ABSSSI prevalence, antibiotic resistance challenges, and outpatient therapy trends. The global market, valued at an estimated $600 million in 2022, could reach over $1 billion by 2030, with North America leading due to established healthcare infrastructure and regulatory approvals.

Potential Market Expansions

• New Indications: Clinical trials exploring dalbavancin for osteomyelitis, bacteremia, and prosthetic joint infections could unlock additional revenue streams.
• Geographical Expansion: Entry into emerging markets where antibiotic resistance is escalating and healthcare infrastructure adapting to outpatient therapies offers growth avenues.
• Pipeline Innovations: Lipoglycopeptide modifications or combination therapies may extend the drug’s lifecycle and revenue potential.

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Challenges and Risks

Key risks include pricing pressures due to generic competition, regulatory challenges in new markets, and evolving clinical guidelines that favor alternative therapies. Also, unforeseen adverse events or emerging resistance could impact utilization.

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Conclusion

Dalbavancin hydrochloride’s market dynamics are characterized by its strategic positioning as a long-acting, outpatient-friendly antibiotic targeting high-resistance infections. Its financial trajectory appears promising, shaped by its clinical advantages, healthcare trends favoring outpatient care, and expanding global reach. Companies with effective reimbursement strategies, proactive pipeline development, and expansion into new indications and geographies are poised to capitalize on this growth trajectory.

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Key Takeaways

• High-value niche: Dalbavancin’s single-dose convenience underpins its appeal for outpatient infections, with expanding adoption expected as healthcare institutions prioritize cost-effective outpatient therapies.
• Growth catalysts: Rising antibiotic resistance and healthcare system shifts toward outpatient care drive future demand.
• Competitive landscape: While facing competition from similar agents and potential generics, dalbavancin’s benefits sustain its competitive edge.
• Market expansion: Beyond ABSSSI, potential indications like osteomyelitis could significantly bolster revenues.
• Pricing and reimbursement: Strategic pricing aligned with healthcare cost savings will be essential for sustained market penetration.

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FAQs

1. What are the primary clinical advantages of dalbavancin hydrochloride?
   Its extended half-life allows for single-dose or weekly dosing, significantly reducing hospital stays and improving patient compliance compared to traditional antibiotics.

2. How does dalbavancin compare with other lipoglycopeptides like oritavancin?
   Both agents share similar long-acting profiles, but dalbavancin’s dosing flexibility and established clinical data give it an early market lead; however, regional preferences and formulary policies influence their adoption.

3. What are the main challenges facing dalbavancin's market growth?
   Price sensitivity, potential generic competition following patent expiry, competition from established antibiotics, and limited approved indications are primary challenges.

4. Are there ongoing clinical trials expanding dalbavancin's indications?
   Yes, studies are evaluating its efficacy in osteomyelitis, bacteremia, and prosthetic device infections, which could broaden its therapeutic scope.

5. What strategies could maximize dalbavancin’s market potential?
   Focus on expanding approved indications, entering emerging markets, demonstrating cost-effectiveness in reimbursement negotiations, and fostering clinician education on its benefits.

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References

1. [1] U.S. Food and Drug Administration (FDA). Dalvance (dalbavancin) prescribing information. 2014.
2. [2] Centers for Disease Control and Prevention (CDC). Antimicrobial resistance in serious bacterial infections. 2021.
3. [3] MarketsandMarkets. Antimicrobial Drugs Market – Global Forecast to 2030. 2022.
4. [4] European Medicines Agency (EMA). Summary of Product Characteristics for Dalvance. 2014.
5. [5] IQVIA. Global Healthcare Data & Analytics. 2022.

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Note: This detailed analysis offers a comprehensive view of the current landscape and future prospects for dalbavancin hydrochloride, empowering stakeholders to make informed strategic decisions based on evolving market factors.