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, Kindos, Teva Pharms Inc, and Abbvie, and is included in four 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.

Four suppliers are listed for this compound.

Summary for dalbavancin hydrochloride

International Patents:	58
US Patents:	1
Tradenames:	2
Applicants:	4
NDAs:	4
Finished Product Suppliers / Packagers:	4
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
Kindos	DALBAVANCIN HYDROCHLORIDE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	218929-001	Nov 26, 2025	AP	RX	No	No
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
South Korea	100930982
New Zealand	588109	Method for Drying Dalbavancin
South Korea	20070015179	DALBAVANCIN COMPOSITIONS FOR TREATMENT OF BACTERIAL INFECTIONS
China	101130060	Medical composition containing dalbavancin
Japan	2011157381	METHOD OF ADMINISTERING DALBAVANCIN FOR TREATMENT OF BACTERIAL INFECTION
Israel	178207	תכשירים רוקחיים המכילים דלבאוואנצין ו/או מנוזיל אגליקון לטיפול בזיהומים חיידקיים (Pharmaceutical compositions comprising dalbavancin and/or mannosyl aglycone for the treatment of bacterial infections)
World Intellectual Property Organization (WIPO)	2004046196

Market Dynamics and Financial Trajectory for Dalbavancin Hydrochloride

Last updated: February 19, 2026

What is the Market Size and Growth Potential for Dalbavancin Hydrochloride?

Dalbavancin hydrochloride is an injectable lipoglycopeptide antibiotic approved primarily for treating complicated skin and soft tissue infections (cSSTIs) caused by Gram-positive pathogens, including methicillin-resistant Staphylococcus aureus (MRSA). The global antimicrobial market, which includes dalbavancin, reached approximately $54 billion in 2022 and is projected to grow at a compound annual growth rate (CAGR) of about 3.5% through 2027 [1].

The segment for lipoglycopeptides, including dalbavancin, is a niche within the antibiotics market. It accounts for an estimated $300 million in 2022, with projections to surpass $500 million by 2027, driven by increasing antibiotic resistance and unmet medical needs for long-acting agents [2].

Market Drivers

• Rise of antibiotic-resistant bacteria, particularly MRSA.
• Advantages of dalbavancin in outpatient settings due to its long half-life allowing weekly dosing.
• Preference for innovative antibiotics to reduce hospitalization costs.

Market Challenges

• High drug costs and reimbursement hurdles.
• Limited approved indications primarily for skin infections.
• Competition from both existing antibiotics and emerging agents.

How Does Dalbavancin Fit Within Competitive Landscape?

Dalbavancin's main competitors include vancomycin, daptomycin, and oritavancin, some of which have broader indications and longer market presence. Oritavancin, another long-acting lipoglycopeptide, received FDA approval in 2014 and competes directly with dalbavancin [3].

The competitive landscape is evolving with the approval of new antibiotics and combinations targeting resistant Gram-positive infections, which may limit dalbavancin’s market share expansion.

What Are the Current Financials and Revenue Trends?

Dalbavancin was first approved by the U.S. Food and Drug Administration (FDA) in May 2014, marketed by Melinta Therapeutics, Inc. Before Melinta’s bankruptcy in 2020, annual sales fluctuated around $122 million in 2019. Post-bankruptcy, sales have declined due to supply interruptions and market cannibalization but are expected to stabilize as new commercial agreements and indications evolve.

Recent financial data indicates:

• Estimated revenue in 2022: approximately $70 million globally.
• Growth projections suggest a compound annual revenue increase of 4-6% through 2027, assuming market stabilization and expanded indications [4].

Pricing and Cost Dynamics

Dalbavancin’s annual treatment costs range from $4,000 to $6,000 per patient, considerably higher than traditional vancomycin therapy ($20 to $50 per dose), justified by reduced hospitalization and outpatient administration.

What Is the Regulatory and Patent Status Affecting Commercialization?

Dalbavancin holds a proprietary market position with patent protection until at least 2030 in major markets. Regulatory agencies such as FDA and EMA have approved the drug for specific indications, but expanding approvals requires additional clinical trials.

Off-label use and potential patent litigations could influence future sales and market exclusivity. The expiration of primary patents may open opportunities for generic formulations, potentially reducing prices.

How Are Market Trends and External Factors Shaping the Outlook?

• Increasing antibiotic resistance underscores demand for novel agents like dalbavancin.
• Healthcare policies favor outpatient treatments to reduce hospital costs.
• Rising antimicrobial stewardship pressures could restrict broad-spectrum antibiotic use, limiting sales unless newer narrower agents are developed.

Emerging data on dalbavancin's use for various indications beyond skin infections, such as osteomyelitis and bacteremia, may expand its market if supported by clinical evidence and regulatory approval.

Summation

Dalbavancin hydrochloride remains a niche but growing segment within the antimicrobial market, driven by the need for long-acting agents against resistant infections. Its commercial viability depends on competitive pressures, regulatory approvals, healthcare policy shifts, and potential expansion into new indications.

Key Financial Metrics Summary

Metric	2022 Estimate	CAGR (2023-2027)	Notes
Global market size for lipoglycopeptides	$300 million	8%	Segment growth rate
Dalbavancin revenue	$70 million	4-6%	Post-2020 stabilization
Patent expiration	2030		Market exclusivity timeline

Key Takeaways

• Dalbavancin's growth hinges on resistance trends and outpatient therapy preference.
• Competition from older and newer antibiotics influences its market share.
• Revenue and pricing models are sensitive to healthcare policies and patent cycles.
• Expansion into new indications may bolster future sales.
• Market entry of generics post-patent expiration could significantly affect profitability.

FAQs

1. What are the primary indications for dalbavancin?
Complicated skin and soft tissue infections caused by Gram-positive bacteria, including MRSA.

2. How does dalbavancin's dosing compare to other antibiotics?
Dalbavancin requires only two doses administered one week apart, compared to daily dosing with vancomycin.

3. What factors could limit dalbavancin’s market growth?
High costs, limited indications, and competition from established antibiotics.

4. Which regulatory approvals are critical for expanding dalbavancin's market?
Expansion into indications like osteomyelitis or bacteremia; approval processes depend on additional clinical data.

5. When will patent protection expire, and what impact could this have?
Patent protection expires around 2030, potentially enabling generic competitors and reducing prices.

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References

[1] Evaluate Pharma. (2022). Global antimicrobial market data.
[2] MarketsandMarkets. (2022). Lipoglycopeptides market outlook.
[3] FDA. (2014). Oritavancin approval announcement.
[4] Company financial reports and analyst estimates (2022–2023).