DALVANCE Drug Patent Profile

When do Dalvance patents expire, and what generic alternatives are available?

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. Five 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
The Foundation for Barnes-Jewish Hospital	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

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
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 DALVANCE

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

Country	Patent Number	Title	Estimated Expiration
Japan	5519090
Singapore	152274	DALBAVANCIN COMPOSITIONS FOR TREATMENT OF BACTERIAL INFECTIONS
Canada	2506236	PROCEDES D'ADMINISTRATION DE DALBAVANCINE DANS LE TRAITEMENTD'INFECTIONS BACTERIENNES (METHODS OF ADMINISTERING DALBAVANCIN FOR TREATMENT OF BACTERIAL INFECTIONS)
Denmark	1565201

DALVANCE (dalbavancin): Market Dynamics and Financial Trajectory

Last updated: April 24, 2026

Dalvance (dalbavancin) is a branded, long-acting lipoglycopeptide antibiotic used for acute bacterial skin and skin structure infections (ABSSSI). Its commercial trajectory is shaped by payer-driven formulary decisions, hospital and outpatient infusion-center purchasing economics, and the post-launch expansion of guideline-aligned indications within ABSSSI care pathways. Financial performance is tied to contracting, utilization of the 2-dose regimen, and competitive pressure from other ABSSSI agents and hospital-managed antibiotic pathways.

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What is DALVANCE’s market position across ABSSSI treatment pathways?

DALVANCE targets ABSSSI episodes where clinicians seek fewer administrations, outpatient eligibility, and reduced inpatient length of stay. The product’s market fit is strongest in care settings where infusion administration cost and operational burden drive antibiotic selection.

Core demand drivers

• Administration economics: DALVANCE’s long half-life supports a 2-dose regimen that can reduce infusion visits versus multi-dose IV schedules used by comparator regimens. This tends to shift value from drug acquisition cost to total cost of care (infusion center capacity, staffing, chair time, and discharge planning).
• Site of care migration: ABSSSI management increasingly treats clinically stable patients in outpatient infusion or alternative care sites. DALVANCE benefits when payers and provider groups support outpatient IV pathways.
• Hospital protocol adoption: In hospital systems with stewardship programs, DALVANCE can be incorporated when protocols emphasize early discharge and simplified IV course management.

Where it tends to perform best

• Hospitals and health systems with strong outpatient infusion programs
• Regions where payer contracting favors drugs that lower total episode cost
• Care pathways that treat ABSSSI with outpatient continuation after initial stabilization

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How do payer and contracting dynamics affect revenue realization?

DALVANCE revenue depends on payer coverage and contracting intensity rather than pure prescribing volume. Pricing and realized net sales are influenced by:

• Formulary placement for ABSSSI: Inclusion in commercial and Medicare Part D formularies affects access for clinician choice.
• Hospital group purchasing organizations (GPOs) and IDN contracts: Health system contracts often determine which branded antibiotic wins the default slot for ABSSSI order sets.
• Prior authorization and step therapy: Where imposed, access latency can suppress early utilization growth.
• Rebates and discounts: Large branded hospital drugs routinely generate meaningful rebate structures tied to volume tiers.

Payer behavior that typically matters for DALVANCE

• Coverage alignment to inpatient vs outpatient thresholds: DALVANCE is most economically compelling when outpatient IV is feasible. Payers that restrict outpatient IV coverage can reduce the advantage of the 2-dose regimen.
• Utilization controls for stewardship: Some payers push clinical criteria that can limit use to specific ABSSSI severity categories.

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What is the competitive landscape that constrains DALVANCE growth?

DALVANCE operates in the ABSSSI antibiotic market where competitive pressure is persistent. Key constraints include:

• Other IV antibiotics with established hospital adoption that compete on clinician familiarity and pathway precedent.
• Short-course and oral-switch strategies that reduce the need for prolonged IV therapy.
• Cost-focused formulary strategies by payers and hospital committees.

Competitive dynamics that change utilization

• Guideline adherence and stewardship protocols: Even where DALVANCE is clinically appropriate, protocols can steer first-line selection toward agents with lower net pricing or stronger local evidence base for specific patient subgroups.
• Contracting and tender cycles: Competitive bidding in IDNs can re-rank drug preferences annually or semiannually.
• Therapeutic substitution in empiric regimens: When empiric therapy is started, subsequent culture data and clinical response can shift selection away from DALVANCE.

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What has been the financial trajectory of DALVANCE since launch?

DALVANCE’s financial trajectory tracks three commercial phases typical for hospital-based specialty antimicrobials:

1. Launch and early uptake: Initial adoption in hospitals with infusion pathway readiness and stewardship openness to simplified IV schedules.
2. Expansion phase: Growth supported by evidence uptake, prescriber familiarity, and protocol embedding for ABSSSI.
3. Mature brand dynamics: Revenue growth becomes harder to sustain as competition tightens, contracts reset, and outpatient pathway economics shift.

What drives year-over-year revenue movement in mature periods

• Contract resets and payer edits: Annual or midyear changes in hospital and payer coverage can produce step changes.
• Seasonality and infection incidence: ABSSSI volumes vary by region and season, affecting total addressable episodes.
• Mix shift within ABSSSI: Utilization depends on severity mix (mild to severe presentations), failure rates that drive retreatment, and site-of-care.

Financial outcome logic (how the trajectory is produced)

• If outpatient infusion adoption rises faster than competitors’ alternatives, DALVANCE typically gains share through operational convenience and reduced infusion burden.
• If payers tighten criteria or hospitals default to lower-net-cost alternatives, DALVANCE typically faces volume headwinds even if clinical outcomes remain favorable.

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How do data and regulatory events influence DALVANCE commercialization?

Commercial trajectory for DALVANCE in the US has been shaped by regulatory and labeling relevance tied to ABSSSI diagnosis boundaries.

Indication scope

DALVANCE is indicated for the treatment of acute bacterial skin and skin structure infections caused by susceptible strains. The product’s uptake depends on how clinicians map ABSSSI severity categories to eligibility criteria and how formularies define appropriate use.

Label-anchored adoption

• Where labeling aligns with institutional order sets, adoption accelerates.
• Where pathway rules impose stricter criteria than labeling, coverage and utilization slow.

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What market metrics best predict DALVANCE revenue performance?

The most actionable revenue predictors for DALVANCE are operational and contracting metrics:

Utilization and access metrics

• Number of covered facilities in IDNs and community hospitals
• Share of ABSSSI prescriptions in covered settings tied to stewardship order sets
• Prior authorization rate and approval latency
• Site-of-care mix (inpatient vs outpatient infusion) for ABSSSI continuation therapy

Contracting and realized revenue metrics

• Net price after rebates and discounts
• Volume-tier effectiveness in hospital contracts
• Payer tier placement and seasonal formulary changes

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What does the DALVANCE value proposition imply for long-term financial sustainability?

DALVANCE’s sustainability depends on maintaining the economic advantage of reduced dosing burden while defending access under tightening cost controls.

Structural strengths

• Patient convenience and operational simplification support adoption in systems focused on length-of-stay reduction and outpatient infusion capacity.
• A dosing schedule that reduces infusion visits supports durable demand if outpatient pathways remain reimbursed and operationally feasible.

Structural risks

• Competitive pricing pressure after contracting cycles reset
• Shifts to alternative antibiotic regimens when stewardship committees revise default choices
• Payer edits limiting outpatient IV coverage reduce the value of simplified administration

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Key Takeaways

• DALVANCE market dynamics are dominated by hospital and payer contracting for ABSSSI, with revenue realization driven by net pricing and access rules rather than only prescription growth.
• The product’s primary commercial edge is operational: a 2-dose IV course that supports outpatient infusion or earlier discharge pathways.
• Competitive pressure and stewardship protocol tightening can suppress utilization even when clinical appropriateness remains intact.
• Long-term financial trajectory depends on contract resets and outpatient IV reimbursement feasibility, which determine whether the dosing convenience translates into durable share.

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FAQs

1) What market segment does DALVANCE target?

DALVANCE targets ABSSSI episodes treated with IV antibiotics where simplified administration supports inpatient discharge or outpatient infusion.

2) What drives DALVANCE revenue more: volume or net price?

Both matter, but realized revenue is highly sensitive to net price and contract terms because access decisions hinge on payer and IDN contracting.

3) Why does outpatient infusion matter for DALVANCE?

DALVANCE’s dosing convenience improves the economics of outpatient IV continuation therapy, so site-of-care mix can materially affect utilization.

4) What are the main constraints to DALVANCE growth?

Contract resets, payer formulary changes, stewardship protocol updates, and competitor substitution in ABSSSI treatment pathways.

5) How does competition typically affect DALVANCE?

Competition re-ranks antibiotic preferences at the formulary and order-set level, often shifting share toward lower-net-cost regimens or faster oral-switch pathways.

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References

[1] Dalvance (dalbavancin) prescribing information. FDA label. https://www.accessdata.fda.gov/
[2] FDA. Drug Trials Snapshots: Dalvance. https://www.fda.gov/