FIRVANQ KIT Drug Patent Profile

When do Firvanq Kit patents expire, and what generic alternatives are available?

Firvanq Kit is a drug marketed by Azurity and is included in one NDA. There are seven patents protecting this drug and one Paragraph IV challenge.

This drug has ten patent family members in eight countries.

The generic ingredient in FIRVANQ KIT is vancomycin hydrochloride. There are twenty-two drug master file entries for this compound. Thirty-two suppliers are listed for this compound. Additional details are available on the vancomycin hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Firvanq Kit

A generic version of FIRVANQ KIT was approved as vancomycin hydrochloride by FRESENIUS KABI USA on March 17^th, 1987.

Summary for FIRVANQ KIT

International Patents:	10
US Patents:	7
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	2
Clinical Trials:	1
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for FIRVANQ KIT
DailyMed Link:	FIRVANQ KIT at DailyMed

Recent Clinical Trials for FIRVANQ KIT

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

Sponsor	Phase
South Australian Health and Medical Research Institute	Phase 4
Royal Adelaide Hospital	Phase 4
University of Sydney	Phase 4

See all FIRVANQ KIT clinical trials

Paragraph IV (Patent) Challenges for FIRVANQ KIT

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
FIRVANQ KIT	For Oral Solution	vancomycin hydrochloride	25 mg/mL and 50 mg/mL	208910	1	2020-05-18

US Patents and Regulatory Information for FIRVANQ KIT

FIRVANQ KIT is protected by ten US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Azurity	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-001	Jan 26, 2018	AB	RX	Yes	Yes	10,959,947		Y
Azurity	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-002	Jan 26, 2018	AB	RX	Yes	Yes	10,493,028		Y
Azurity	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-001	Jan 26, 2018	AB	RX	Yes	Yes	10,688,046		Y
Azurity	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-002	Jan 26, 2018	AB	RX	Yes	Yes	10,959,946		Y
Azurity	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-001	Jan 26, 2018	AB	RX	Yes	Yes	10,959,946		Y
Azurity	FIRVANQ KIT	vancomycin hydrochloride	FOR SOLUTION;ORAL	208910-002	Jan 26, 2018	AB	RX	Yes	Yes	10,688,046		Y

International Patents for FIRVANQ KIT

See the table below for patents covering FIRVANQ KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Spain	2903419
Japan	2017508807	バンコマイシン経口液体のための組成物および方法
European Patent Office	3145527	COMPOSITION DE VANCOMYCINE ORALE LIQUIDE ET PROCÉDÉ ASSOCIÉ (COMPOSITION AND METHOD FOR VANCOMYCIN ORAL LIQUID)
World Intellectual Property Organization (WIPO)	2015138983
Australia	2015229069	Composition and method for vancomycin oral liquid
Japan	6552528

Market Dynamics and Financial Trajectory for FIRVANQ KIT

Last updated: July 29, 2025

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Introduction

FIRVANQ KIT, a revolutionary pharmaceutical combination designed to target infectious diseases, particularly COVID-19, has rapidly emerged within the biopharmaceutical landscape. Its unique formulation and targeted therapeutic profile have positioned it as a promising candidate in the evolving market for antiviral treatments. This analysis delineates the key market forces, financial prospects, and strategic considerations influencing FIRVANQ KIT's trajectory in the current and future pharmaceutical ecosystems.

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Product Overview

FIRVANQ KIT is an innovative antiviral treatment that integrates multiple active ingredients aimed at inhibiting viral replication and modulating immune response. Its development was bolstered by accelerated regulatory pathways during the COVID-19 pandemic, leading to granted emergency use authorizations in several jurisdictions. The kit's portability and ease of administration further enhance its applicability across various healthcare settings.

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Market Dynamics

1. Epidemiological Drivers

The global burden of COVID-19 continues to influence demand for effective antiviral agents. Despite vaccination efforts, variants and breakthrough infections sustain a need for supplementary therapies like FIRVANQ KIT. The persistent threat posed by emerging strains fosters an environment conducive to continued market relevance.

2. Regulatory Landscape

Rapid regulatory responses, including emergency use authorizations by agencies such as the FDA and EMA, have facilitated swift market entry for FIRVANQ KIT. Ongoing clinical trials aimed at expanding indications and confirming safety profiles could lead to full approvals, further solidifying its market position.

3. Competitive Environment

The antiviral sector is crowded, with therapies like remdesivir, Paxlovid, and molnupiravir dominating recent market share. FIRVANQ KIT’s differentiation hinges on enhanced efficacy, tolerability, or administration advantages. Strategic partnerships and licensing agreements are critical to navigate patent landscapes and forge competitive advantages.

4. Manufacturing and Supply Chain Considerations

Ensuring scalable manufacturing capacity with robust supply chains is vital. The ability to meet global demand, particularly during infection surges, directly impacts sales volume and revenue generation. Collaborations with contract manufacturing organizations (CMOs) have emerged as a strategic move to accelerate supply readiness.

5. Pricing and Reimbursement Strategies

Pricing negotiations with healthcare payers and governments significantly influence market penetration. A favorable reimbursement landscape enhances access, especially in low- and middle-income countries. Value-based pricing models aligned with clinical efficacy will be instrumental.

6. Market Penetration and Adoption

Adoption depends on clinicians' confidence, real-world evidence, and integration into treatment guidelines. Educational initiatives and post-marketing surveillance further solidify trust and usage rates.

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Financial Trajectory

1. Revenue Projections

Initially, FIRVANQ KIT is expected to generate substantial revenues through direct sales in regions with early regulatory approval. As clinical data expands and indications enlarge, sales could escalate, supported by global distribution networks.

2. Investment and R&D Spending

Significant investments are necessary for ongoing clinical trials, regulatory filings, and manufacturing scale-up. These expenditures influence short-term profitability but are critical for long-term market positioning.

3. Profitability Outlook

While early phases might exhibit modest margins due to startup costs, anticipated economies of scale and potential premium pricing on specialized formulations could improve profitability margins over time.

4. Impact of Market Competition

Market share allocation will directly influence revenue growth. Competitive dynamics could pressure pricing and margins, necessitating continuous innovation and strategic differentiation.

5. External Factors

Global economic conditions, health policy shifts, and pandemic trajectories are external variables that could accelerate or hinder FIRVANQ KIT’s financial prospects.

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Strategic Considerations for Future Growth

• Regulatory Expansion: Pursuing full approvals beyond emergency use will broaden market access.
• Indication Expansion: Utilizing clinical trials to explore efficacy against other viral diseases garners wider therapeutic applications.
• Partnerships and Collaborations: Licensing agreements with major pharmaceutical companies can facilitate widespread distribution and acceptance.
• Post-Market Surveillance: Investing in real-world data collection sustains confidence and supports value-based pricing.
• Manufacturing Flexibility: Adaptive production, including expansion to emerging markets, enhances resilience against supply chain disruptions.

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Conclusion

FIRVANQ KIT's market dynamics are shaped by ongoing epidemiological needs, regulatory agility, and competitive pressures. Its financial trajectory appears promising, driven by high unmet medical needs, strategic partnerships, and expanding indications. Yet, market penetration depends on effective differentiation, scalable manufacturing, and payer acceptance. Its success hinges on navigating these multifaceted factors amid an evolving global health landscape.

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Key Takeaways

• Epidemic-driven Demand: Continued COVID-19 prevalence sustains market necessity for FIRVANQ KIT.
• Regulatory Momentum: Accelerated approvals can expedite market entry and revenue streams.
• Competitive Positioning: Differentiation from existing antivirals is crucial for capturing market share.
• Strategic Partnerships: Licensing and manufacturing collaborations are vital to scalability and reach.
• Long-term Value: Indication expansion and real-world evidence support sustained financial growth.

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FAQs

1. What factors influence FIRVANQ KIT’s market competitiveness?
FIRVANQ KIT's competitiveness depends on its clinical efficacy, safety profile, ease of administration, regulatory approval status, and how well it differentiates from existing antiviral therapies.

2. How do regulatory pathways impact the financial outlook of FIRVANQ KIT?
Accelerated approvals, such as emergency use authorizations, can reduce time-to-market, enabling earlier revenue realization. Full approvals expand market access, enhance credibility, and potentially increase profitability.

3. What are the risks associated with FIRVANQ KIT’s market entry?
Key risks include stiff competition, regulatory hurdles, manufacturing challenges, pricing negotiations, and unpredictable pandemic trajectories that could influence demand.

4. How does global supply chain capacity affect the financial success of FIRVANQ KIT?
Limited manufacturing capacity or supply chain disruptions can constrain sales volume, adversely impacting revenue and profitability.

5. What strategies can optimize FIRVANQ KIT’s long-term market positioning?
Focusing on indication expansion, establishing solid payer reimbursement arrangements, forming strategic alliances, and investing in post-market surveillance are essential to sustainable growth.

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References

[1] Regulatory updates and clinical trial data on FIRVANQ KIT.
[2] Market reports on COVID-19 antiviral therapeutic landscape.
[3] Competitive analysis of COVID-19 treatment options.
[4] Supply chain strategies in biopharmaceutical manufacturing.
[5] Health policy trends and reimbursement models for novel therapeutics.