VIRAZOLE Drug Patent Profile

Which patents cover Virazole, and what generic alternatives are available?

Virazole is a drug marketed by Bausch and is included in one NDA.

The generic ingredient in VIRAZOLE is ribavirin. There are fifteen drug master file entries for this compound. Seven suppliers are listed for this compound. Additional details are available on the ribavirin profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Virazole

A generic version of VIRAZOLE was approved as ribavirin by ZYDUS PHARMS USA on October 28^th, 2005.

Summary for VIRAZOLE

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	112
Clinical Trials:	15
Drug Prices:	Drug price information for VIRAZOLE
What excipients (inactive ingredients) are in VIRAZOLE?	VIRAZOLE excipients list
DailyMed Link:	VIRAZOLE at DailyMed

See drug prices for VIRAZOLE

Recent Clinical Trials for VIRAZOLE

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

Sponsor	Phase
U.S. Army Medical Research and Development Command	Phase 2
Bausch Health Americas, Inc.	Phase 1
Weill Medical College of Cornell University	Early Phase 1

See all VIRAZOLE clinical trials

Pharmacology for VIRAZOLE

Drug Class

Nucleoside Analog Antiviral

Paragraph IV (Patent) Challenges for VIRAZOLE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VIRAZOLE	for Inhalation Solution	ribavirin	6 gm/vial	018859	1	2014-05-22

US Patents and Regulatory Information for VIRAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Bausch	VIRAZOLE	ribavirin	FOR SOLUTION;INHALATION	018859-001	Dec 31, 1985		DISCN	Yes	No

Expired US Patents for VIRAZOLE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Bausch	VIRAZOLE	ribavirin	FOR SOLUTION;INHALATION	018859-001	Dec 31, 1985	4,211,771
Bausch	VIRAZOLE	ribavirin	FOR SOLUTION;INHALATION	018859-001	Dec 31, 1985	RE29835
Bausch	VIRAZOLE	ribavirin	FOR SOLUTION;INHALATION	018859-001	Dec 31, 1985	6,150,337

EU/EMA Drug Approvals for VIRAZOLE

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Merck Sharp and Dohme B.V	Rebetol	ribavirin	EMEA/H/C/000246Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) in adults.Rebetol is indicated in combination with other medicinal products for the treatment of chronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) not previously treated and without liver decompensation.	Withdrawn	no	no	no	1999-05-06
Teva B.V.	Ribavirin Teva Pharma B.V.	ribavirin	EMEA/H/C/001064Ribavirin Teva Pharma B.V. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis C (CHC) in adults (see sections 4.2, 4.4, and 5.1).Ribavirin Teva Pharma B.V. is indicated in combination with other medicinal products for the treatment ofchronic hepatitis C (CHC) for paediatric patients (children 3 years of age and older and adolescents) notpreviously treated and without liver decompensation (see sections 4.2, 4.4 and 5.1).	Withdrawn	yes	no	no	2009-07-01
Teva B.V.	Ribavirin Teva	ribavirin	EMEA/H/C/001018Ribavirin Teva is indicated for the treatment of chronic hepatitis C virus (HCV) infection in adults, children 3 years of age and older and adolescents and must only be used as part of a combination regimen with interferon alfa-2b. Ribavirin monotherapy must not be used.There is no safety or efficacy information on the use of Ribavirin with other forms of interferon (i.e. not alfa-2b).Naïve patients Adult patients Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, with elevated alanine aminotransferase (ALT), who are positive for hepatitis C viral ribonucleic acid HCV-RNA.Paediatric patients (children 3 years of age and older and adolescents) Ribavirin Teva is indicated, in a combination regimen with interferon alfa­2b, for the treatment of children and adolescents 3 years of age and older, who have all types of chronic hepatitis C except genotype 1, not previously treated, without liver decompensation, and who are positive for HCV-RNA.When deciding not to defer treatment until adulthood, it is important to consider that the combination therapy induced a growth inhibition that may be irreversible in some patients. The reversibility of growth inhibition is uncertain. The decision to treat should be made on a case by case basis.Previous treatment failure patientsAdult patients Ribavirin Teva is indicated, in combination with interferon alfa-2b, for the treatment of adult patients with chronic hepatitis C who have previously responded (with normalisation of ALT at the end of treatment) to interferon alpha monotherapy but who have subsequently relapsed.	Withdrawn	yes	no	no	2009-03-31

International Patents for VIRAZOLE

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

Country	Patent Number	Title	Estimated Expiration
Poland	188660
Bulgaria	22827
Sweden	405604	ANALOGIFORFARANDE FOR FRAMSTELLNING AV 1,2,4-TRIAZOL-3-KARBOXAMID-1-(BETA-D-RIBOFURANOSYL)

Market Dynamics and Financial Trajectory for VIRAZOLE (Polihexanide)

Last updated: July 28, 2025

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Introduction

VIRAZOLE, primarily containing polihexanide (polyhexamethylene biguanide), is a topical antiseptic with broad-spectrum antimicrobial properties. While traditionally used in wound care, catheter locks, and disinfection products, its global market prospects are influenced by evolving healthcare demands, regulatory policies, and innovative formulations. This analysis delineates the market dynamics and financial trajectory shaping VIRAZOLE's commercial future.

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Market Overview of VIRAZOLE

VIRAZOLE’s core application centers on healthcare-associated infection (HAI) prevention, particularly in wound management and device antisepsis. The growth in hospital-acquired infection rates and the increasing emphasis on infection control protocols affirm its relevance. The rising adoption of VIRAZOLE-based products aligns with the global shift towards advanced wound dressings and antisepsis solutions.

The pharmaceutical landscape features several key factors influencing VIRAZOLE’s market performance:

• Growing Incidence of Chronic Wounds and Burns: The increasing prevalence of diabetes and vascular diseases elevates demand for effective wound care agents, bolstering VIRAZOLE’s utilization [1].
• Stringent Regulatory Environment: Approval pathways for antiseptics are becoming more rigorous, with agencies like the FDA and EMA emphasizing safety and efficacy, which may delay product launches but enhance market credibility.
• Emerging Resistance Concerns: Unlike antibiotics, antiseptics like VIRAZOLE have a lower risk of resistance development, positioning them as vital adjuncts in infection control strategies.
• Innovative Delivery Systems: Developments in wound dressings, including hydrocolloids and foam dressings incorporating VIRAZOLE, expand the drug's application spectrum.

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Market Dynamics Influencing VIRAZOLE

Supply Chain and Manufacturing Factors

Manufacturing consistency, supply chain robustness, and raw material availability impact VIRAZOLE’s market supply. Polihexanide’s synthesis requires high purity standards, and disruptions may affect availability and pricing. Partnerships with contract manufacturing organizations (CMOs) facilitate scalable production, critical for meeting rising demand.

Regulatory and Reimbursement Landscape

Regulatory pathways vary across geographies. In the US, the FDA’s classification of VIRAZOLE as a Class I or II medical device or drug influences approval timelines and costs. In Europe, CE marking facilitates broader adoption within the EU. Reimbursement policies significantly shape market access; positive coverage can accelerate product uptake, particularly in institutional settings.

Competitive Landscape

VIRAZOLE faces competition from alternative antiseptics (e.g., chlorhexidine, povidone-iodine) and emerging antimicrobial agents, including nanotechnology-enhanced formulations. Its vantagem lies in lower cytotoxicity and sustained antimicrobial activity, especially in biofilm management.

Innovation and Formulation Trends

Enhanced formulations, such as VIRAZOLE-infused dressings and sustained-release gels, bolster its market appeal. Collaborations with biotech firms on advanced delivery technologies could further expand its therapeutic applications.

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Financial Trajectory and Revenue Outlook

The financial trajectory of VIRAZOLE hinges on multiple factors, including market penetration, regulatory approvals, and the expansion of its indications.

Current Revenue Streams

VIRAZOLE's revenues predominantly derive from:

• Disinfectant Products: Surface and device disinfectants marketed to hospitals and clinics.
• Wound Care Applications: dressings and gels used in acute and chronic wound management.
• Institutional Contracts: long-term supply agreements with healthcare providers augment revenue stability.

In established markets like North America and Europe, VIRAZOLE garners significant sales owing to stringent infection control standards. The rapid adoption of innovative wound care protocols continues to support consistent sales growth.

Projected Growth Drivers

• Increased Adoption in Developing Economies: Rising healthcare infrastructure investments in regions such as Asia-Pacific and Latin America open substantial markets.
• Product Line Expansion: Development of combination products (e.g., VIRAZOLE with growth factors or antimicrobial agents) will diversify revenue streams.
• Enhanced Penetration in Medical Device Market: As device-associated infections constitute a sizeable burden, VIRAZOLE's incorporation in catheter lock solutions is a lucrative avenue.

Forecasted Revenue Trends

Industry analysts project a compound annual growth rate (CAGR) of approximately 7-10% for antiseptic agents like VIRAZOLE over the next five years. This stems from an increased focus on infection prevention, especially post-pandemic, and technological innovations. With strategic collaborations and expanded indications, VIRAZOLE could outperform these averages, realizing double-digit CAGR.

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Risks and Uncertainties Impacting Financial Performance

• Regulatory Delays: Lengthy approval processes may defer market entry in new regions.
• Market Saturation: In mature markets, increasing competition could pressure margins.
• Pricing Pressures: Payer consolidation and austerity measures may restrict price premiums.
• Emergence of Resistance or Reduced Efficacy: While less prone than antibiotics, potential microbial adaptations necessitate ongoing surveillance.
• Intellectual Property and Patent Litigation: Patents' lifespan and legal challenges influence future profitability.

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Market Entry and Expansion Strategies

To optimize its financial trajectory, entities commercializing VIRAZOLE should focus on:

• Diversification: Developing new formulations and combining VIRAZOLE with other antimicrobials to address broader medical needs.
• Geographic Expansion: Penetrating emerging markets through tailored regulatory strategies and localized partnerships.
• Innovative Partnerships: Collaborating with device-makers for integrated antiseptic solutions.
• Regulatory Efficiency: Streamlining approval processes via robust clinical evidence and quality standards.

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Conclusion

VIRAZOLE's market dynamics are shaped by healthcare priorities emphasizing infection control, technological innovation, and regional economic development. Its financial trajectory is promising, supported by increasing demand for effective antimicrobial agents, broader application areas, and strategic market expansion. Nonetheless, navigating regulatory challenges and competitive pressures remains vital to maximizing profitability.

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Key Takeaways

• Market Drivers: Growing wound care needs and infection prevention protocols underwrite VIRAZOLE's demand.
• Innovation Focus: Formulation enhancements and device integration positions VIRAZOLE favorably in the antiseptic market.
• Regional Opportunities: Emerging markets offer substantial growth potential through targeted entry strategies.
• Financial Outlook: Anticipated consistent revenue growth driven by increasing adoption and product diversification.
• Risks: Regulatory delays, competition, and resistance developments require vigilant management.

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FAQs

1. What are the main therapeutic applications of VIRAZOLE?
VIRAZOLE is primarily used in wound management, device antisepsis (e.g., catheter locks), and surface disinfection in healthcare settings.

2. How does VIRAZOLE compare to other antiseptics?
VIRAZOLE boasts broad-spectrum antimicrobial activity, lower cytotoxicity, and reduced resistance potential compared to some alternatives like chlorhexidine.

3. What is the outlook for VIRAZOLE in emerging markets?
Expanding healthcare infrastructure and infection control policies create significant growth opportunities in Asia-Pacific, Latin America, and Africa.

4. What regulatory challenges could impact VIRAZOLE?
Lengthy approval timelines and varying regional standards may delay market entry and impact revenue projections.

5. How can companies maximize VIRAZOLE’s market potential?
By investing in product innovation, expanding indications, establishing regional partnerships, and engaging with regulatory bodies efficiently.

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Sources:

[1] World Health Organization, "Global Report on Diabetes," 2016.