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.

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

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

DrugPatentWatch^® Generic Entry Outlook for Dalvance

Dalvance was eligible for patent challenges on May 23, 2018.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 23, 2028. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DALVANCE

International Patents:	58
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	3
Clinical Trials:	6
Patent Applications:	672
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

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for DALVANCE

Constraining patent/regulatory exclusivity:

6,900,175

NDA:

021883

Dosage:

POWDER;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

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

US Patents and Regulatory Information for DALVANCE

DALVANCE is protected by one US patents.

This potential generic entry date is based on patent 6,900,175.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	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	8,143,212
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

International Patents for DALVANCE

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

Country	Patent Number	Title	Estimated Expiration
Russian Federation	2005119206	СПОСОБЫ ВВЕДЕНИЯ ДАЛБАВАНЦИНА ДЛЯ ЛЕЧЕНИЯ БАКТЕРИАЛЬНЫХ ИНФЕКЦИЙ
Russian Federation	2333766	СПОСОБЫ ВВЕДЕНИЯ ДАЛБАВАНЦИНА ДЛЯ ЛЕЧЕНИЯ БАКТЕРИАЛЬНЫХ ИНФЕКЦИЙ (METHODS OF DALBAVANCIN ADMINISTRATION FOR TREATMENT OF BACTERIAL INFECTION)
South Korea	100930982
Portugal	1565201

Dalbavancin Market Dynamics and Financial Trajectory

Market Introduction

Dalbavancin, marketed as Dalvance, is a second-generation lipoglycopeptide antibiotic designed to treat severe bacterial skin and skin structure infections in adults, including those caused by methicillin-resistant Staphylococcus aureus (MRSA). It was the first drug approved under the Generating Antibiotic Incentives Now (GAIN) Act, part of the FDA Safety and Innovation Act[4].

Market Dynamics

Drivers

• Increasing Resistance to Antibiotics: The rise in antibiotic-resistant bacteria, particularly MRSA, has created a significant demand for effective antibiotics like dalbavancin. This drug's efficacy against MRSA and other gram-positive organisms drives its market growth[1][4].
• Technological Advancements: Advances in medical technology and the development of more sophisticated diagnostic tools have improved the detection and treatment of bacterial infections, contributing to the growth of the dalbavancin market[1].
• Aging Population: The increasing geriatric population is another key driver, as older adults are more susceptible to severe bacterial infections. This demographic shift is expected to boost the demand for dalbavancin[1].

Restraints

• Awareness and Education: While increased awareness about dalbavancin has reduced ignorance about its availability, it also highlights the need for careful use to avoid resistance. This balanced awareness can sometimes restrain market growth by promoting judicious use rather than widespread adoption[1].
• Regulatory and Pricing Pressures: Strict regulatory environments and pricing pressures can limit the market expansion of dalbavancin. Healthcare systems often face budget constraints, which can affect the adoption rate of newer, potentially more expensive antibiotics[4].

Opportunities

• Expanding Indications: Clinical studies and ongoing research may expand the indications for dalbavancin beyond current uses, potentially increasing its market share. For instance, recent studies by the European Medicines Agency (EMA) have highlighted its advantages over other antibiotics like vancomycin and linezolid[4].
• Global Health Initiatives: Public health initiatives aimed at combating antibiotic resistance and improving healthcare infrastructure, especially in developing regions, could create new opportunities for the dalbavancin market[3].

Market Segmentation

By Type

The dalbavancin market is segmented into intravenous therapy and oral types. Intravenous therapy is the primary mode of administration due to the drug's pharmacokinetic properties and the need for rapid therapeutic effects in severe infections[1].

By Application

The market is categorized into skin infections, soft tissue infections, and other applications. Skin infections, particularly those caused by MRSA, constitute a significant portion of the market due to the drug's efficacy in this area[1][4].

By Distribution Channel

Hospital pharmacies are the major distribution channels, followed by retail and online pharmacies. The dominance of hospital pharmacies is due to the acute nature of the infections treated with dalbavancin, which often require immediate medical attention[4].

Regional Overview

North America

North America is a significant market for dalbavancin, driven by advanced healthcare infrastructure and high awareness about antibiotic-resistant infections. The region is expected to continue its growth trajectory due to ongoing research and clinical trials[1].

Europe

The European market for dalbavancin is projected to grow at a CAGR of 7.2% from 2022 to 2032, reaching USD 150.2 million by 2032. Germany is expected to be a major contributor to this growth, with hospital pharmacies being the primary distribution channel[4].

Asia-Pacific, Middle East, and Africa

These regions are also expected to see growth, albeit at a slower pace compared to North America and Europe. The growth will be driven by increasing healthcare spending and the need for effective antibiotics to combat rising antibiotic resistance[1].

Financial Trajectory

Revenue Forecast

The global dalbavancin market is anticipated to witness significant growth, with the European market alone expected to reach USD 150.2 million by 2032. The CAGR for this period is projected to be around 7.2%[4].

Key Players

Major pharmaceutical companies such as AbbVie Inc., Pfizer Inc., and Teva Pharmaceutical Industries Ltd. are key players in the dalbavancin market. These companies invest heavily in research and development, which drives market growth and innovation[1][4].

Financial Performance of Key Players

For example, AbbVie Inc. reported full-year net revenues of $54.318 billion in 2023, with a focus on expanding its portfolio through acquisitions. While the financial performance of specific drugs like dalbavancin is not always detailed in company reports, the overall revenue and growth strategies of these companies indicate a positive outlook for the antibiotic market[5].

Impact of COVID-19

The COVID-19 pandemic has put significant pressure on healthcare systems worldwide, highlighting the need for effective antibiotics. While the pandemic has presented challenges, it has also accelerated the adoption of drugs like dalbavancin due to the increased focus on infectious disease management[4].

Key Takeaways

• Dalbavancin is a critical antibiotic for treating severe bacterial skin and skin structure infections, particularly those caused by MRSA.
• The market is driven by increasing antibiotic resistance, technological advancements, and an aging population.
• Key restraints include awareness and education about judicious use and regulatory pricing pressures.
• The market is segmented by type, application, and distribution channel, with intravenous therapy and hospital pharmacies being dominant.
• Regional growth varies, with North America and Europe leading the market.
• Major pharmaceutical companies are key players, with significant investments in R&D.

FAQs

Q: What is dalbavancin used for? Dalbavancin is used to treat severe bacterial skin and skin structure infections in adults, including those caused by MRSA.

Q: What are the key drivers of the dalbavancin market? The key drivers include increasing antibiotic resistance, technological advancements, and an aging population.

Q: Which regions are expected to lead the growth of the dalbavancin market? North America and Europe are expected to be the leading regions, with significant growth also anticipated in the Asia-Pacific and other regions.

Q: How has the COVID-19 pandemic impacted the dalbavancin market? The pandemic has accelerated the adoption of dalbavancin due to the increased focus on infectious disease management, despite presenting challenges to healthcare systems.

Q: Who are the major players in the dalbavancin market? Major players include AbbVie Inc., Pfizer Inc., and Teva Pharmaceutical Industries Ltd.

Cited Sources:

1. The Insight Partners - Dalbavancin Market Key Players Analysis 2031
2. PR Newswire - Allergan Reports Fourth Quarter and Full-Year 2019 Financial Results
3. ASPE - Antimicrobial Drugs Market Returns Analysis
4. Market.US - Europe Dalbavancin Market Size, Share, Trends | Forecast to 2032
5. AbbVie - AbbVie Reports Full-Year and Fourth-Quarter 2023 Financial Results