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 one branded drug marketed by Abbvie and is included in one NDA. 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.

One supplier is listed for this compound.

Summary for DALBAVANCIN HYDROCHLORIDE

International Patents:	58
US Patents:	1
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	18
Clinical Trials:	24
Patent Applications:	1,824
DailyMed Link:	DALBAVANCIN HYDROCHLORIDE at DailyMed

Recent Clinical Trials for DALBAVANCIN HYDROCHLORIDE

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

Sponsor	Phase
Wake Forest University Health Sciences	Phase 4
Centre Hospitalier de Perigueux	Phase 3
French National Network of Clinical Research in Infectious Diseases (RENARCI)	Phase 3

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

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
Abbvie	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014		RX	Yes	Yes
Abbvie	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014		RX	Yes	Yes
Abbvie	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014		RX	Yes	Yes	6,900,175
Abbvie	DALVANCE	dalbavancin hydrochloride	POWDER;INTRAVENOUS	021883-001	May 23, 2014		RX	Yes	Yes

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	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 DALBAVANCIN HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
New Zealand	588109	Method for Drying Dalbavancin
South Korea	20050094396	METHODS OF ADMINISTERING DALBAVANCIN FOR TREATMENT OF BACTERIAL INFECTIONS
Mexico	PA05005338	METODOS PARA ADMINISTRAR DALBAVANCIN PARA EL TRATAMIENTO DE INFECCIONES BACTERIANAS. (METHODS OF ADMINISTERING DALBAVANCIN FOR TREATMENT OF BACTERIAL INFECTIONS.)
Russian Federation	2352353	КОМПОЗИЦИИ ДАЛБАВАНЦИНА ДЛЯ ЛЕЧЕНИЯ БАКТЕРИАЛЬНЫХ ИНФЕКЦИЙ (COMPOSITIONS OF DALBAVANCIN FOR TREATMENT OF BACTERIEMIC INFECTIONS)
Israel	230875
South Korea	101173310

DALBAVANCIN HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Dalbavancin Hydrochloride: Market Dynamics and Financial Trajectory

Market Introduction

Dalbavancin hydrochloride, marketed as Xydalba, is a second-generation lipoglycopeptide antibiotic designed to treat severe bacterial skin and skin structure infections (ABSSSIs) in adults, including those caused by methicillin-resistant Staphylococcus aureus (MRSA)[1][3][4].

Market Dynamics

Drivers

• Increasing Resistance to Antibiotics: The rise in antibiotic-resistant bacteria, particularly MRSA, has created a significant demand for effective treatments like dalbavancin. Its efficacy against MRSA and other gram-positive organisms is a key driver of market growth[1][3].
• Technological Advancements: Advances in pharmaceutical technology have improved the production and delivery of dalbavancin, enhancing its market appeal[1].
• Geriatric Population Growth: The increasing geriatric population, which is more susceptible to severe infections, is another factor driving the market[1].

Restraints

• High Cost: Dalbavancin is more expensive than many other antibiotics, which can limit its adoption. For instance, the treatment course costs $2,872 per patient, making it less cost-effective compared to some generic alternatives[4].
• Limited Comparative Evidence: There is insufficient evidence to support a price premium for dalbavancin over other antibiotics, which can affect its market acceptance[4].
• Regulatory and Economic Evaluations: Health authorities like CADTH have raised concerns about the cost-effectiveness of dalbavancin, which can impact its reimbursement and market penetration[4].

Opportunities

• Growing Healthcare Needs: The COVID-19 pandemic has highlighted the need for effective antibiotics, providing an opportunity for dalbavancin to fill the gap in healthcare systems[3].
• Market Expansion: The drug has potential for expansion in various regions, particularly in Europe where it is projected to grow significantly by 2032[3].

Market Segmentation

By Type

• Intravenous Therapy: This is the primary mode of administration for dalbavancin, offering a convenient and effective treatment option for severe infections[1].
• Oral Type: Although less common, oral formulations are also available, catering to different patient needs[1].

By Application

• Skin Infections: This segment accounts for a significant portion of the market, given the drug's efficacy in treating skin infections, including those caused by MRSA[1][3].
• Soft Tissue Infections: Dalbavancin is also effective in treating soft tissue infections, further expanding its market scope[1][3].

By Distribution Channel

• Hospital Pharmacies: These are the primary distribution channels, given the drug's use in hospital settings for severe infections[3].
• Retail Pharmacies and Online Pharmacies: These channels also contribute to the market, especially for outpatient treatments[3].

Regional Framework

Europe

• The European market for dalbavancin is projected to grow from USD 75.9 million in 2022 to USD 150.2 million by 2032, at a CAGR of 7.2%[3].
• Germany is expected to account for the majority of the revenue share in the European market[3].

Global Market

• The global dalbavancin market is anticipated to grow at a significant CAGR by 2031, driven by increasing demand in North America, Asia-Pacific, and other regions[1].

Financial Performance and Revenue

Revenue Growth

• Correvio Pharma Corp., one of the companies marketing dalbavancin (Xydalba), reported revenue of approximately $2.6 million from Xydalba in the first quarter of 2019, a 16% year-over-year increase in local currencies[5].
• The global market size is expected to increase significantly, with the market forecasted to reach USD XX million by 2031 from USD XX million in 2023[1].

Cost and Pricing

• The high cost of dalbavancin, with a treatment course costing $2,872 per patient, is a significant factor affecting its financial trajectory. For it to be cost-effective, the price would need to be reduced substantially[4].

Competitive Landscape

• Key players in the market include AbbVie Inc., Pfizer Inc., Teva Pharmaceutical Industries Ltd., and Advanz Pharma Corp. Ltd. These companies are focusing on organic and inorganic growth strategies such as product launches, acquisitions, and partnerships to expand their market share[1][3].

Pharmacoeconomic Considerations

Cost-Effectiveness Analysis

• Studies by CADTH indicate that dalbavancin IV may not be cost-effective compared to other antibiotics like vancomycin and ceftriaxone, due to its high cost and uncertain incremental benefits[4].

Incremental Cost-Effectiveness Ratio (ICER)

• The ICER for dalbavancin IV compared to ceftriaxone IV was estimated to be $401,168 per QALY gained, highlighting the need for a significant price reduction to make it cost-effective[4].

Key Takeaways

• Dalbavancin hydrochloride is a critical antibiotic for treating severe bacterial skin and skin structure infections.
• The market is driven by increasing antibiotic resistance and technological advancements but is restrained by high costs and limited comparative evidence.
• The European market is expected to grow significantly, with Germany leading the revenue share.
• Financial performance is influenced by high treatment costs and the need for price adjustments to achieve cost-effectiveness.
• Key players are adopting various growth strategies to maintain market presence.

FAQs

What is dalbavancin hydrochloride used for?

Dalbavancin hydrochloride is used to treat severe bacterial skin and skin structure infections, including those caused by MRSA.

What are the key drivers of the dalbavancin market?

The key drivers include increasing antibiotic resistance, technological advancements, and the growing geriatric population.

How is the European market for dalbavancin projected to grow?

The European market is projected to grow from USD 75.9 million in 2022 to USD 150.2 million by 2032 at a CAGR of 7.2%.

Why is dalbavancin considered expensive?

Dalbavancin is expensive, with a treatment course costing $2,872 per patient, making it less cost-effective compared to some generic alternatives.

Which companies are key players in the dalbavancin market?

Key players include AbbVie Inc., Pfizer Inc., Teva Pharmaceutical Industries Ltd., and Advanz Pharma Corp. Ltd.

Cited Sources:

1. The Insight Partners - Dalbavancin Market Key Players Analysis 2031
2. Newswire.ca - Cardiome Reports Third Quarter 2017 Financial Results
3. Market.US - Europe Dalbavancin Market Size, Share, Trends | Forecast to 2032
4. NCBI - Pharmacoeconomic Review - Dalbavancin (Xydalba)
5. BioSpace - Correvio Reports First Quarter 2019 Financial Results