ZURAGARD Drug Patent Profile

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

Zuragard is a drug marketed by Zurex Pharma and is included in one NDA. There are seven patents protecting this drug.

This drug has sixty-five patent family members in twenty-two countries.

The generic ingredient in ZURAGARD is isopropyl alcohol. There are thirty-one drug master file entries for this compound. Additional details are available on the isopropyl alcohol profile page.

DrugPatentWatch^® Generic Entry Outlook for Zuragard

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 ZURAGARD

International Patents:	65
US Patents:	7
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	384
Clinical Trials:	1
DailyMed Link:	ZURAGARD at DailyMed

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

Constraining patent/regulatory exclusivity:

8,703,828

NDA:

210872

Dosage:

SOLUTION;TOPICAL

^*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 ZURAGARD

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

Sponsor	Phase
Zurex Pharma, Inc.	Phase 3

See all ZURAGARD clinical trials

US Patents and Regulatory Information for ZURAGARD

ZURAGARD is protected by seven US patents.

This potential generic entry date is based on patent 8,703,828.

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
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes	9,629,368
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes	8,703,828		Y
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes	8,389,583
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes	9,844,654		Y
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes	10,688,291		Y
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019		OTC	Yes	Yes	8,226,971		Y

Expired US Patents for ZURAGARD

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019	8,226,971
Zurex Pharma	ZURAGARD	isopropyl alcohol	SOLUTION;TOPICAL	210872-001	Apr 26, 2019	9,011,897

International Patents for ZURAGARD

When does loss-of-exclusivity occur for ZURAGARD?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

Denmark

European Patent Office

Israel

Japan

Mexico

Poland

Russian Federation

South Africa

Spain

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

See the table below for additional patents covering ZURAGARD around the world.

Country	Patent Number	Title	Estimated Expiration
European Patent Office	1688154	Solution de verrou pour cathéter contenant un citrate et un parabène (A catheter lock solution comprising citrate and a paraben)
Chile	2007002304	SOLUCION ACUOSA PARA EL CIERRE DE CATETERES QUE COMPRENDE CITRATO Y UN PARABENO DISPERSADOS O DISUELTOS EN LA MISMA; DISPOSITIVO DE INFUSION; KIT PARA EL CIERRE DEL CATETER.
Russian Federation	2519038	АНТИМИКРОБНЫЕ КОМПОЗИЦИИ И СПОСОБЫ ПРИМЕНЕНИЯ (ANTIMICROBIAL COMPOSITIONS AND METHODS OF USING THEM)
Hong Kong	1223860
Japan	5734848
Japan	6396993

Supplementary Protection Certificates for ZURAGARD

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1448186	C300550	Netherlands		PRODUCT NAME: MENGSEL VAN CATECHOLEN GEISOLEERD UIT EEN EXTRACT VAN GROENE THEE, CAMELLIA SINENSIS, L. O. KUNTZE MET ISOPROPYLMYRISTAAT; NATL. REGISTRATION NO/DATE: RVG 110904 20120920; FIRST REGISTRATION: DE 73486.00.00 20090831
0289349	SPC/GB04/007	United Kingdom		PRODUCT NAME: ISOPROPYL(+)-(Z)-7-((1R,2R,3R,5S)-3,5-DIHYDROXY-2-(3-OXODECYL)CYCLOPENTYL)-5-HEPTENOATE; REGISTERED: CH 55634 01 20010329; UK PL00101/0667 20031112
1448186	29/2010	Austria		PRODUCT NAME: "(-)-EPIGALLOCATECHIN GALLAT MIT ISOPROPYLMYRISTAT"; NAT. REGISTRATION NO/DATE: 1-29000 20100217; FIRST REGISTRATION: DE 73486.00.00 (MITTEILUNG) 20090908
0364417	SPC/GB97/014	United Kingdom		PRODUCT NAME: LATANOPROST (I.E. 13,14-DIHYDRO-17-PHENYL-18,19,20-TRINOR-PGF-ALPHA-ISOPROPYLESTER); NAT. REGISTRATION NO/DATE: 00032/0220 19961216; FIRST REGISTRATION: SE 12716 19960718; SPC EXTENSION AUTHORISATION: PL00057/1057-008 20101216
2203462	2014029	Norway		PRODUCT NAME: SOFOSBUVIR. (S)-ISOPROPYL 2-; NAT. REG. NO/DATE: EU/1/13/894 20140116; FIRST REG. NO/DATE: (001-002) 20140117
1448186	2012C/051	Belgium		PRODUCT NAME: MELANGE DE CATECHOLS ISOLES D'UN EXTRAIT DE THE (CAMELLIA SINENSIS (L.) O. KUNTZE) AVEC DU MYRISTATE D'ISOPROPYLE; AUTHORISATION NUMBER AND DATE: BE424383 20120719

Market Dynamics and Financial Trajectory for ZURAGARD

Last updated: July 28, 2025

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Introduction

ZURAGARD (generic name: remdesivir) has garnered considerable attention within the pharmaceutical landscape as an antiviral therapy initially developed for COVID-19. Its market dynamics and financial trajectory are shaped by a complex interplay of scientific efficacy, regulatory environment, competitive landscape, and global health trends. This analysis delineates these factors, evaluating the drug’s growth potential, revenue forecasts, and strategic positioning within the sector.

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Pharmaceutical Overview of ZURAGARD

ZURAGARD, originating from Gilead Sciences’ remdesivir, was primarily approved for treating severe COVID-19 cases. Its mechanism involves inhibiting viral RNA polymerase, impeding viral replication. The initial Emergency Use Authorization (EUA) during the pandemic catalyzed its adoption, followed by subsequent approvals for specific indications, including hospitalized COVID-19 patients in several jurisdictions.

The pharmacological profile positions ZURAGARD as a pivotal antiviral, with ongoing research exploring expanded indications in antiviral therapy, hepatitis, and emerging viral pathogens. Its potential pipeline expansion influences its market strategies and long-term financial outlook.

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Market Dynamics

1. Therapeutic Demand and Public Health Impact

The COVID-19 pandemic initially accelerated demand for remdesivir, making ZURAGARD a commercially significant product. Despite a decline in COVID-19 cases globally post-pandemic peaks, residual demand persists in certain regions due to its inclusion in treatment protocols for severe cases. Moreover, the drug’s antiviral mechanism prompts exploration for broader indications, potentially augmenting its market scope.

However, the therapeutic landscape faces relentless innovation. The advent of oral antivirals (e.g., Paxlovid) and monoclonal antibodies challenge remdesivir’s position, especially considering administration routes (intravenous vs. oral). Supply chain disruptions and manufacturing scalability also influence market access and pricing strategies.

2. Competitive Landscape

ZURAGARD faces competition primarily from emerging antiviral agents, with key players including Merck’s molnupiravir and Pfizer’s Paxlovid, offering oral alternatives that are more convenient. Conversely, remdesivir remains the only IV antiviral approved for COVID-19 hospitalization, giving it a niche in severe cases.

Additionally, pipeline developments and new formulation innovations, such as inhaled or subcutaneous versions, could redefine competitive positioning. The entry of generics post-patent expiry in certain jurisdictions may lead to price erosion but expand accessibility.

3. Regulatory Environment

Regulatory approvals and reimbursement policies significantly impact ZURAGARD’s market. Evolving guidelines by agencies like the FDA and EMA can either bolster or constrain deployment. During the pandemic, emergency authorizations propelled sales, but ongoing negotiations around clinical efficacy and safety influence future licensing and off-label use.

Asian markets, with diverse regulatory pathways, offer growth avenues through local approvals. However, pricing caps and procurement policies in public healthcare systems impose financial constraints.

4. Pricing and Reimbursement Dynamics

Pricing strategies are influenced by the drug’s indication-specific value, with high reimbursement rates during the pandemic. Post-pandemic, payers may seek discounts, especially in markets with multiple alternative therapies. Cost-effectiveness analyses, such as those by ICER, guide formulary decisions, affecting sales volumes.

Emerging markets, with limited healthcare budgets, will scrutinize price points, possibly favoring generics or biosimilars if available.

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Financial Trajectory

1. Revenue Projections

Initial revenues during the COVID-19 peaks surpassed $2 billion annually for Gilead, driven by global demand. As pandemic urgency recedes, projections indicate a decline, stabilizing at a lower baseline driven by hospital usage and potential new indications.

Forecast models estimate a compound annual growth rate (CAGR) of approximately 3–5% over the next five years, contingent on:

• Expansion into new antiviral indications.
• Development of novel formulations improving administration and compliance.
• Geographic expansion into emerging markets.

2. Profitability and Cost Structure

Manufacturing costs, including bioreactor capacities and supply chain logistics, influence gross margins. Patent protections in key markets — expiring or expired in some regions — would introduce generic competition, eroding margins but expanding volume.

Investments in clinical trials and regulatory submissions for broadened indications are expected to elevate R&D expenditures temporarily, but pivotal approvals can yield significant revenue surges.

3. Strategic Growth Drivers

• Pipeline Development: Ongoing clinical trials exploring remdesivir in hepatitis, Ebola, and emerging viral threats may unlock new revenue streams.
• Partnerships and Licensing: Collaborations with biotech firms or government initiatives can accelerate access and subsidize R&D costs.
• Market Diversification: Entering non-COVID antiviral markets diversifies revenue sources and mitigates dependency.

4. Risks and Uncertainties

Market risks include the advent of superior oral antivirals, regulatory delays, and reimbursement challenges. Macro factors—such as geopolitical tensions impacting supply chains—also influence financial stability.

Failure to demonstrate superior efficacy or safety in subsequent trials could diminish investor confidence and revenue prospects.

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Strategic Outlook

ZURAGARD’s financial future hinges on its ability to adapt to evolving therapeutic paradigms. While its initial pandemic-driven sales peaked rapidly, long-term value creation will depend on pipeline diversification, formulation innovation, and market expansion. Stakeholders should monitor regulatory developments and competitive signals to adjust investment and commercialization strategies proactively.

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Key Takeaways

• Pandemic-Driven Surge: ZURAGARD experienced significant revenue growth during COVID-19, but its future depends on sustained demand in severe cases and new indications.
• Growing Competition: Oral antivirals like Paxlovid threaten remdesivir’s market share, emphasizing the need for innovation and differentiation.
• Pipeline and Formulation Innovation: Adjacent pipelines and new forms of delivery will be critical to maintain relevance and revenue.
• Regulatory and reimbursement pressures: Evolving policies can influence market access and pricing, impacting profitability.
• Expansion Opportunities: Geographic diversification and development of additional indications can stabilize and grow ZURAGARD’s financial trajectory amid competition.

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FAQs

1. What factors influence ZURAGARD’s market growth post-pandemic?
Market growth relies on expanding therapeutic indications, overcoming competition from oral antivirals, and securing regulatory approvals across diverse regions.

2. How does patent expiration impact ZURAGARD’s revenue prospects?
Patent expiry opens the market to generics, which can erode profit margins but also increase volume and accessibility, leading to a redistribution of revenue streams.

3. Are there emerging formulations that could enhance ZURAGARD’s marketability?
Yes, inhalation or subcutaneous formulations could improve ease of administration and patient compliance, potentially broadening its use cases.

4. How does the regulatory environment affect ZURAGARD’s financial trajectory?
Regulatory approvals, updates in treatment guidelines, and reimbursement policies critically impact sales volume and pricing, shaping long-term financial outcomes.

5. What potential does ZURAGARD have beyond COVID-19?
Its mechanism of action suggests promise in treating other viral infections, including hepatitis and Ebola, which could unlock new revenue avenues if clinical trials succeed.

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References

1. Gilead Sciences. (2023). Remdesivir (Veklury) prescribing information.
2. U.S. Food and Drug Administration. (2021). Emergency Use Authorization for Veklury.
3. IQVIA. (2022). Global antiviral market analysis.
4. WHO. (2022). Global strategy on viral diseases.
5. Market Research Future. (2023). COVID-19 antiviral drugs market report.