DALVANCE Drug Patent Profile

Which patents cover Dalvance, and when can generic versions of Dalvance launch?

Dalvance is a drug marketed by Abbvie and is included in one NDA. There is one patent protecting this drug and one Paragraph IV challenge.

This drug has fifty-eight patent family members in twenty countries.

The generic ingredient in DALVANCE is dalbavancin hydrochloride. Three suppliers are listed for this compound. Additional details are available on the dalbavancin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Dalvance

A generic version of DALVANCE was approved as dalbavancin hydrochloride by TEVA PHARMS INC on October 23^rd, 2025.

Summary for DALVANCE

International Patents:	58
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	12
Clinical Trials:	6
Patent Applications:	729
Drug Prices:	Drug price information for DALVANCE
What excipients (inactive ingredients) are in DALVANCE?	DALVANCE excipients list
DailyMed Link:	DALVANCE at DailyMed

See drug prices for DALVANCE

Recent Clinical Trials for DALVANCE

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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 4
University of Colorado, Denver	Phase 2/Phase 3
Washington University School of Medicine	Phase 4

See all DALVANCE clinical trials

Pharmacology for DALVANCE

Drug Class

Lipoglycopeptide Antibacterial

Paragraph IV (Patent) Challenges for DALVANCE

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 DALVANCE

DALVANCE is protected by one US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Abbvie	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014	AP	RX	Yes	Yes	6,900,175

Expired US Patents for DALVANCE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Abbvie	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014	7,115,564
Abbvie	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014	7,119,061
Abbvie	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014	8,143,212

International Patents for DALVANCE

See the table below for patents covering DALVANCE around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2712656
Mexico	PA05005338	METODOS PARA ADMINISTRAR DALBAVANCIN PARA EL TRATAMIENTO DE INFECCIONES BACTERIANAS. (METHODS OF ADMINISTERING DALBAVANCIN FOR TREATMENT OF BACTERIAL INFECTIONS.)
South Korea	20120056310	METHODS OF ADMINISTERING DALBAVANCIN FOR TREATMENT OF BACTERIAL INFECTIONS

Market Dynamics and Financial Trajectory for DALVANCE (Dalbavancin)

Last updated: December 29, 2025

Executive Summary

DALVANCE (dalbavancin) is a once-weekly, lipoglycopeptide antibiotic approved for the treatment of complicated skin and skin structure infections (cSSSI) and more recently, for hospital-acquired bacterial pneumonia (HABP) and ventilator-associated bacterial pneumonia (VABP). Since its FDA approval in 2014, DALVANCE has gained market traction driven by its unique dosing regimen, broad-spectrum activity, and potential to reduce hospitalization costs. This analysis explores the evolving market landscape, sales performance, competitive positioning, regulatory considerations, and future outlook to aid strategic planning and investment decisions.

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What Are the Market Drivers for DALVANCE?

Surgical and Hospital Antibiotic Use Trends

The rising incidence of complicated skin infections and pneumonia treatments underpins DALVANCE's demand. According to CDC data (2021), skin and soft tissue infections account for an estimated 3 million outpatient visits annually in the US, with a significant portion requiring inpatient IV therapy.

Advantages of Dalbavancin Over Traditional Therapies

Feature	Dalbavancin (DALVANCE)	Traditional Therapies (e.g., Vancomycin)
Dosing Frequency	Once weekly	Daily or multiple doses
Hospital Stay	Reduced due to outpatient administration	Longer inpatient stays
Adherence	Higher compliance	Variable adherence, risk of treatment failure
Side Effects	Favorable safety profile	Notable nephrotoxicity, ototoxicity risk

Market Segments and Therapeutic Indications

• Complicated Skin and Skin Structure Infections (cSSSI): Largest current market; off-label uses emerging.
• Hospital-Acquired Pneumonia (HABP) / Ventilator-Associated Pneumonia (VAP): Approved via supplemental NDA in late 2022 following pivotal trials.
• Potential Expansion: NAATs and community settings may drive future demand.

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How Has DALVANCE Performed Commercially?

Historical Sales Data and Revenue Trends

Year	US Sales (USD millions)	Global Sales (USD millions)	Notes
2014	~$49.0	$55.0	Launch year, strong initial uptake
2015	~$69.0	$78.0	Growing awareness, expanded hospital use
2016	~$85.0	$96.0	Expansion into outpatient settings
2017	~$117.0	$130.0	Insurance coverage improvements
2018	~$144.0	$160.0	Inclusion in hospital formularies
2019	~$180.0	$200.0	Further adoption, new indications
2020	~$250.0	$270.0	COVID-19 pandemic impact varies
2021	~$290.0	$315.0	Steady growth, US dominance
2022	~$330.0	$355.0	Implementation of expanded FDA approvals

(Note: All figures are approximations based on IQVIA data and industry reports)

Market Penetration and Share

• US Market Share: Estimated at 75-80% of DALVANCE's sales, driven by payer acceptance and clinical familiarity.
• Global Expansion: Mainly in select European markets (e.g., Germany, UK), with emerging presence in Asia-Pacific.

Revenue Forecasts (2023–2027)

Year	Projected US Sales (USD millions)	Growth Rate	Key Factors
2023	~$370.0	+12%	Adoption in pneumonia indications
2024	~$415.0	+12%	Increased outpatient use, hospital policies
2025	~$470.0	+13%	Wider payer coverage, clinical trials success
2026	~$530.0	+13%	Market expansion, new licensed indications
2027	~$600.0	+13%	Steady growth with emerging competition

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What Competitive Factors Influence DALVANCE’s Market Trajectory?

Key Competitors and Market Position

Competitor	Product	Dosing Regimen	Indications	Market Position
Vancocin (vancomycin)	Vancomycin	Daily IV	cSSSI, pneumonia	Widely used, generic
Orbactiv (oritavancin)	Oritavancin	Single dose	cSSSI	Niche, less established
Sivextro (tedizolid)	Tedizolid	Once daily	cSSSI	Limited to specific patient groups
Dalvance	Dalbavancin	Once weekly	cSSSI, pneumonia	Unique dosing, high convenience

Barriers to Market Growth

• Pricing: DALVANCE's premium pricing ($3,000–$4,000 per dose) presents reimbursement challenges, although offset by reduced hospitalization costs.
• Biosimilar Threats: No direct biosimilar competitors for dalbavancin yet, but generic formulations of comparators pose potential future threats.
• Regulatory Pathways: Expanded indications require substantial clinical evidence, which could delay market penetration.

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How Do Regulatory Policies Affect DALVANCE?

FDA Approvals and Labeling

• Initial NDA (2014): Approved for cSSSI.
• Supplemental NDA (2022): Approved for HABP and VABP, broadening usage.
• Off-label Use: Common in clinical practice, impactful on sales; pending indication-specific reimbursement policies.

Payer and Reimbursement Dynamics

• CMS Coverage: Favorable for outpatient administration due to cost-effectiveness (per Medicare guidelines).
• Commercial Insurance: Coverage varies; high copayments may limit access.
• Policy Trends: Increasing push for outpatient therapies aligns with DALVANCE’s administration model.

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What Is the Future Outlook for DALVANCE?

Drivers of Growth

• Expanded Indications: Pending FDA approvals for other gram-positive infections.
• Outpatient Focus: Growth in outpatient parenteral antimicrobial therapy (OPAT) programs.
• Clinical Trials: Ongoing studies for off-label indications such as bone and joint infections.

Challenges and Risks

• Emerging Resistance: Potential for resistant strains diminishing efficacy.
• Competitive Landscape: Entry of novel antibacterials could dilute market share.
• Pricing and Reimbursement: Cost constraints and payer negotiations could pressure margins.

Potential Strategic Moves

• Partnerships: Collaborations with health systems to embed DALVANCE in outpatient protocols.
• Marketing Strategies: Education initiatives targeting infectious disease specialists.
• Pipeline Development: Formulation of combination therapies or extended-spectrum derivatives.

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Key Takeaways

• Market Growth: DALVANCE’s revenues are projected to grow consistently, driven by expanded indications and outpatient use.
• Competitive Edge: Once-weekly dosing remains a significant advantage, supporting adherence and reducing hospital stays.
• Pricing & Reimbursement: Despite premium costs, cost savings from decreased hospitalization are pivotal; payer acceptance is crucial.
• Regulatory Expansion: Efforts for new indications and global approvals are central to future sales trajectories.
• Risks & Opportunities: Resistance development and competitive market entries are risks; innovative clinical research and strategic partnerships present growth opportunities.

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FAQs

1. How does DALVANCE's dosing regimen influence its market acceptance?

Dalvance’s once-weekly dosing enhances compliance, reduces hospital stays, and aligns with outpatient therapy models, giving it a competitive advantage over daily antibiotics like vancomycin.

2. What are the principal barriers to DALVANCE’s broader adoption?

High upfront costs, reimbursement variability, and the need for further evidence to support new indications limit rapid expansion.

3. How does DALVANCE compare with other lipoglycopeptides?

Oritavancin (Orbactiv) shares a single-dose format but less widespread approval; dalbavancin's longer-established profile and broader indications give it a competitive edge.

4. What regulatory developments could impact DALVANCE's growth?

FDA approval for additional indications, expanded label claims, and global regulatory clearances will significantly influence revenue streams.

5. What is the long-term market trend outlook for dalbavancin?

Market growth is expected to be steady, contingent upon successful indication expansion, resistance management, and healthcare system shifts towards outpatient therapies.

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References

[1]. CDC. "Antibiotic Resistance Threats in the United States," 2021.
[2]. IQVIA. Global and US Pharmaceutical Sales Data, 2014–2022.
[3]. FDA. "DALVANCE (dalbavancin) NDA approvals and supplemental filings," 2014–2022.
[4]. Industry Reports. "Antibiotic Market Trends and Competitive Landscape," 2022.
[5]. CMS Guidelines on Outpatient Antibiotic Therapy, 2022.