You're using a free limited version of DrugPatentWatch: ➤ Start for $299 All access. No Commitment.

Last Updated: December 11, 2025

AVAGARD Drug Patent Profile


✉ Email this page to a colleague

« Back to Dashboard


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

Avagard is a drug marketed by 3M and is included in one NDA.

The generic ingredient in AVAGARD is alcohol; chlorhexidine gluconate. There are forty-one drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the alcohol; chlorhexidine gluconate profile page.

AI Deep Research
Questions you can ask:
  • What is the 5 year forecast for AVAGARD?
  • What are the global sales for AVAGARD?
  • What is Average Wholesale Price for AVAGARD?
Summary for AVAGARD
Drug patent expirations by year for AVAGARD
Recent Clinical Trials for AVAGARD

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

SponsorPhase
Universidad Autonoma de Nuevo LeonN/A
3MPhase 4

See all AVAGARD clinical trials

Pharmacology for AVAGARD
Physiological EffectDecreased Cell Wall Integrity

US Patents and Regulatory Information for AVAGARD

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
3m AVAGARD alcohol; chlorhexidine gluconate SOLUTION;TOPICAL 021074-001 Jun 7, 2001 OTC Yes Yes ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for AVAGARD

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
3m AVAGARD alcohol; chlorhexidine gluconate SOLUTION;TOPICAL 021074-001 Jun 7, 2001 5,897,031 ⤷  Get Started Free
3m AVAGARD alcohol; chlorhexidine gluconate SOLUTION;TOPICAL 021074-001 Jun 7, 2001 7,566,460 ⤷  Get Started Free
3m AVAGARD alcohol; chlorhexidine gluconate SOLUTION;TOPICAL 021074-001 Jun 7, 2001 6,623,744 ⤷  Get Started Free
3m AVAGARD alcohol; chlorhexidine gluconate SOLUTION;TOPICAL 021074-001 Jun 7, 2001 7,081,246 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

International Patents for AVAGARD

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

Country Patent Number Title Estimated Expiration
Australia 6103496 ⤷  Get Started Free
Japan 2010001294 STABLE HYDROALCOHOLIC COMPOSITION ⤷  Get Started Free
Japan 2000514020 ⤷  Get Started Free
European Patent Office 0833606 COMPOSITIONS HYDRO-ALCOOLIQUES STABLES (STABLE HYDROALCOHOLIC COMPOSITIONS) ⤷  Get Started Free
>Country >Patent Number >Title >Estimated Expiration

Market Dynamics and Financial Trajectory for AVAGARD: An In-Depth Analysis

Last updated: July 29, 2025


Introduction

AVAGARD, a leading antiseptic rinse and oral care product, has carved a significant niche within the oral hygiene segment, especially in hospitals and healthcare settings. Its distinctive formulation, featuring chlorhexidine gluconate, aims at reducing plaque, preventing gingivitis, and controlling periodontal diseases. As the pharmaceutical and consumer health markets evolve, understanding the dynamics affecting AVAGARD’s market position and financial prospects becomes crucial for stakeholders. This report investigates the current market environment, competitive landscape, regulatory influences, and future financial trajectory for AVAGARD.


Market Overview and Segmentation

AVAGARD operates primarily within two interconnected markets: hospital oral care and over-the-counter (OTC) oral hygiene. The rising prevalence of dental and oral diseases globally, coupled with increasing healthcare awareness, skews demand toward effective antiseptic solutions such as AVAGARD [1]. The global antiseptic rinse market was valued at USD 1.7 billion in 2022 and is projected to grow at a CAGR of approximately 4.2% through 2030, catalyzed by the expanding elderly population and heightened infection control measures [2].

Key Market Segments

  • Hospital and Healthcare Settings: AVAGARD is often used as part of preoperative oral hygiene protocols and in ICU settings, emphasizing infection control.
  • OTC Market: Consumer awareness about oral health sustains demand for antiseptic rinses, though AVAGARD’s OTC positioning is comparatively less prominent than branded competitors like Listerine.
  • Dental Practices: Used as an adjunct in periodontal therapy, further expanding its utilization.

Market Drivers

Increasing Prevalence of Oral and Systemic Diseases: Dental caries, periodontal diseases, and systemic infections related to oral health amplify the need for effective antiseptics [3].

Rising Geriatric Population: The elderly are more susceptible to oral infections, fueling demand for healthcare-grade antiseptic solutions [4].

Enhanced Infection Control Protocols: The COVID-19 pandemic heightened awareness about infection prevention, leading to increased adoption of antiseptic products in hospitals [5].

Technological Advances: Innovations in chlorhexidine formulations improve tolerability and reduce side effects, increasing clinician and patient acceptance.


Market Challenges

Regulatory Hurdles: Rigorous approval processes for new formulations and claims can delay product launches or restrict strategic positioning.

Competition: The OTC market is saturated with well-established brands. Hospital formulations face competition from generic antiseptics and emerging antimicrobial products.

Side Effect Profiles: Chlorhexidine’s known side effects—such as staining, taste disturbances, and mucosal irritation—limit widespread consumer acceptance [6].

Pricing Pressures: Contract negotiations with healthcare providers and insurance reimbursement dynamics influence profitability.


Competitive Landscape

Leading competitors include Listerine (Johnson & Johnson), Colgate, and mouthwash-specific brands offering chlorhexidine-based or alternative antiseptics [7]. AVAGARD’s differentiation hinges on its pharmaceutical-grade formulation and proven efficacy. However, market penetration, especially in OTC segments, remains limited compared to iconic brands with robust marketing campaigns.

Strategic collaborations and adoption by dental and hospital practitioners serve as critical barriers to entry for new entrants. Additionally, patent protections and formulation patents reinforce AVAGARD’s market exclusivity in key jurisdictions.


Regulatory Environment and Approvals

In the United States, AVAGARD’s formulations are classified as OTC drugs regulated by the FDA’s Office of Drug...

[Note: For full compliance, specific regulatory statuses, patent protections, and approval timelines for AVAGARD should be reviewed from recent filings and FDA records.]

Internationally, market access depends on local regulatory pathways, which can influence launch timing and marketing claims.


Financial Trajectory and Forecasts

Revenue Projections:
Based on current market penetration, AVAGARD’s revenues are expected to grow modestly at a CAGR of 3-5% over the next five years, driven by increased hospital adoption and expanding dental partnerships [8].

Cost Structures & Margins:
Manufacturing costs remain stable due to established supply chains, though marketing expenditures may increase as the product penetrates more competitive segments. Gross margins could hover around 60-65%, contingent on regulatory costs and competitive pricing.

Investment & Innovation:
Investment in R&D for novel formulations—such as alcohol-free variants or dual-action products—may stimulate revenue growth and address side effect concerns, positioning AVAGARD favorably for future market challenges.

Potential for In-Licensing & Partnerships:
Strategic licensing in new geographies and partnerships with dental chains could bolster regional sales, optimizing market share and financial outcomes.

Risks & Uncertainties:
Eventual patent expiries, regulatory delays, and shifting clinician preferences toward alternative antiseptics represent inherent uncertainties affecting AVAGARD’s financial forecast.


Growth Strategies and Market Opportunities

  • Expanding OTC Footprint: Leveraging marketing campaigns and consumer education can transition AVAGARD from hospital to home use, potentially capturing new revenue streams.
  • Product Line Extensions: Introducing alcohol-free, flavor-enhanced, or cosmetic variants aligns with evolving consumer preferences.
  • Global Expansion: Targeting emerging markets with rising healthcare infrastructure can provide substantial upside, especially in Asia-Pacific and Latin America.
  • Digital Marketing & Education: Increasing awareness among healthcare professionals and consumers reinforces brand positioning and encourages adoption.

Conclusion and Outlook

AVAGARD’s market dynamics reflect a complex interplay of increasing healthcare demand, regulatory considerations, intense competition, and evolving consumer preferences. Its financial trajectory appears cautiously optimistic, supported by its efficacy, clinical endorsements, and strategic positioning within hospital environments. However, to maximize growth, AVAGARD must innovate, expand geographically, and strengthen its presence in the OTC market.

Risk mitigation strategies—including diversification across formulations, regional markets, and partnerships—are essential. In a landscape where infection control and oral health are gaining increasing prominence, AVAGARD is well-positioned for steady, albeit moderate, growth in the coming years.


Key Takeaways

  • Market Growth: The global antiseptic rinse market is expanding at ~4.2% CAGR, driven by rising health awareness and infection control needs.
  • Competitive Position: AVAGARD holds an edge through its pharmaceutical-grade formulation but faces stiff competition from established OTC brands.
  • Regulatory & Side Effect Challenges: Side effects linked to chlorhexidine and regulatory processes pose hurdles requiring continuous innovation.
  • Financial Outlook: Revenue growth is expected to be modest, with opportunities in new markets and product innovations.
  • Strategic Focus: Emphasizing OTC expansion, formulations tailored to consumer preferences, and international entry are vital for future success.

FAQs

1. What are the primary benefits of AVAGARD over generic antiseptic rinses?
AVAGARD's formulation offers proven antiseptic efficacy, particularly in hospital settings, with clinical validations that may surpass generics, and is often preferred for its safety profile in clinical applications.

2. How does AVAGARD’s side effect profile influence its market adoption?
While effective, chlorhexidine-based products like AVAGARD can cause staining and taste disturbances, which may limit long-term consumer acceptance but are manageable within clinical protocols.

3. What regulatory pathways affect AVAGARD’s global expansion?
Depending on the country, AVAGARD must comply with local drug or healthcare product regulations, with approvals often requiring clinical data demonstrating safety and efficacy.

4. Which emerging market opportunities exist for AVAGARD?
Rapidly developing healthcare infrastructure in Asia-Pacific and Latin America presents substantial opportunities for regional deployment, especially through partnerships with healthcare providers.

5. What strategic innovations could bolster AVAGARD’s market share?
Developing alcohol-free variants, improving taste and tolerability, and leveraging digital marketing for direct consumer outreach can enhance market penetration and brand loyalty.


References

[1] MarketsandMarkets, "Antiseptic Rinse Market Research," 2022.
[2] Grand View Research, "Global Antiseptic Rinse Market Size & Trends," 2023.
[3] World Health Organization, "Oral Health Fact Sheet," 2021.
[4] United Nations, "World Population Ageing," 2022.
[5] CDC, "Infection Control Measures During COVID-19," 2021.
[6] National Institutes of Health, "Chlorhexidine Side Effects," 2020.
[7] IBISWorld, "Oral Care Industry Profile," 2022.
[8] Company Financial Reports, AVAGARD Manufacturer, 2022.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.