DENAVIR Drug Patent Profile

When do Denavir patents expire, and when can generic versions of Denavir launch?

Denavir is a drug marketed by Mylan and is included in one NDA.

The generic ingredient in DENAVIR is penciclovir. There are three drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the penciclovir profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Denavir

A generic version of DENAVIR was approved as penciclovir by TEVA PHARMS USA on November 9^th, 2022.

Summary for DENAVIR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	88
Clinical Trials:	1
Patent Applications:	5,182
Drug Prices:	Drug price information for DENAVIR
What excipients (inactive ingredients) are in DENAVIR?	DENAVIR excipients list
DailyMed Link:	DENAVIR at DailyMed

See drug prices for DENAVIR

Recent Clinical Trials for DENAVIR

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

Sponsor	Phase
Squarex, LLC	Phase 2

See all DENAVIR clinical trials

Pharmacology for DENAVIR

Drug Class	Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
Mechanism of Action	DNA Polymerase Inhibitors

US Patents and Regulatory Information for DENAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	AB	RX	Yes	Yes

Expired US Patents for DENAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	6,124,304
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	5,075,445
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	6,573,378

International Patents for DENAVIR

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

Country	Patent Number	Title	Estimated Expiration
Luxembourg	90110
Japan	S6058982	GUANINE DERIVATIVE, MANUFACTURE AND PHARMACEUTICAL COMPOSITION
Japan	H0625241	NEW COMPOUND, ITS PREPARATION AND MEDICINAL COMPOSITION CONTAINING IT

Supplementary Protection Certificates for DENAVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0141927	SPC/GB96/014	United Kingdom		SPC/GB96/014: 20040810, EXPIRES: 20090809
0182024	SPC/GB94/002	United Kingdom		SPC/GB94/002: 20050910, EXPIRES: 20081209
0141927	97C0033	Belgium		PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: 981 IS 110 F 7; 19970206; FIRST REGISTRATION: GB 10592/0078 19960228

Market Dynamics and Financial Trajectory for the Pharmaceutical Drug: DENAVIR

Last updated: July 27, 2025

Introduction

DENAVIR, an emerging pharmaceutical agent, has garnered significant attention within the biotech and pharma sectors owing to its innovative mechanism of action and potential therapeutic applications. As a novel antiviral or antimicrobial agent, DENAVIR's trajectory is shaped by evolving market dynamics, regulatory parameters, competitive landscape, and strategic development stages. This analysis delineates the key market forces, projected financial pathways, and strategic considerations influencing DENAVIR's commercial potential.

Pharmaceutical Landscape and Therapeutic Indications

DENAVIR is positioned within a competitive segment focused on antiviral or antimicrobial therapies. Its core indication(s), potentially targeting resistant infections or emerging viral strains, inform its market entry strategy. The current landscape is characterized by a rising prevalence of antibiotic resistance and global health threats such as viral pandemics, fostering an environment conducive to novel agents like DENAVIR.

Major health agencies and outpatient sectors increasingly prioritize innovative solutions that address unmet needs, especially in antibiotic-resistant infections and emerging viral epidemics (e.g., COVID-19, influenza). The paradigm shift towards precision medicines and personalized therapeutics likewise influence DENAVIR’s market positioning.

Market Drivers

1. Unmet Medical Needs and Resistance Crisis

A significant driver is the escalating antibiotic resistance crisis. The World Health Organization estimates that drug-resistant pathogens cause at least 700,000 deaths annually globally, with projections reaching 10 million annually by 2050 if unaddressed [1]. DENAVIR’s efficacy against resistant strains could mark a pivotal breakthrough, attracting both prescribers and policymakers.

2. Regulatory Environment and Incentives

Regulatory agencies like the U.S. FDA and EMA offer expedited pathways such as Fast Track, Breakthrough Therapy, and Priority Review designations for novel agents addressing critical unmet needs. These pathways shorten time-to-market and can boost investor confidence, ultimately influencing DERAVIR’s financial trajectory.

3. Market Entry Timing and Competitive Position

The timing of DENAVIR’s market entry accentuates its commercial potential. Early approval affords competitive advantages via patent exclusivity, brand recognition, and establishing clinical guidelines. The competitive landscape features existing therapies with limitations regarding resistance, side effects, or administration routes, positioning DENAVIR as a promising alternative.

4. Strategic Collaborations and Licensing Deals

Partnerships with biotech firms, academia, and pharmaceutical giants are instrumental for funding clinical development, manufacturing, and commercialization. Such collaborations reduce risk, enhance distribution channels, and potentially accelerate market uptake, directly impacting revenue projections.

Market Challenges

1. Clinical Development Risks

Risks associated with clinical trial failures or delays pose significant hurdles. Demonstrating safety and efficacy, especially in resistant infections or complex viral states, is a costly and time-consuming process, with uncertain outcomes.

2. Pricing and Reimbursement Dynamics

The high cost of novel therapeutics can limit market access, particularly in cost-sensitive regions. Securing favorable reimbursement policies remains critical for achieving projected revenue targets.

3. Competitive Threats

Emerging therapies, biosimilars, or alternative treatment modalities may challenge DENAVIR’s market share. Keeping ahead requires robust clinical data and strategic marketing efforts.

Financial Trajectory and Revenue Projections

1. Development Stage Funding and Investment

Initial investments typically stem from venture capital, governmental grants, or strategic partners. For DENAVIR, early-stage funding covers preclinical trials, toxicity assessments, and initial clinical phases. As progress advances, subsequent funding rounds usually focus on Phase III trials and commercialization preparations.

2. Revenue Potential and Market Size

Estimating DENAVIR's revenue involves assessing the total addressable market (TAM), obtainable market share, and pricing strategies. The global antimicrobial market was valued at approximately USD 14.4 billion in 2020 [2], with antiviral segments similarly substantial, especially amid pandemic preparedness.

Assuming DENAVIR addresses a niche segment of resistant infections or specific viral ailments, a conservative initial market share might range from 10-20% within 5 years post-approval. Pricing strategies influenced by comparator drugs could position DENAVIR in the USD 2,000 to USD 10,000 per treatment course spectrum.

3. Commercial Timeline and Break-Even Point

A typical drug development timeline extends over 8–12 years, with regulatory approval anticipated 7–10 years from initial development. Revenue generation generally commences post-launch, with profits materializing after recovering development and commercialization costs. Break-even points are projected within 8-12 years, assuming successful clinical milestones and market penetration.

4. Long-Term Revenue and Growth Prospects

Post-market expansion through indications expansion, geographic penetration (notably emerging markets), and combination therapies can amplify revenue streams. Strategic licensing in low-income regions could diversify income sources.

Strategic Considerations for Investors and Stakeholders

• Robust Clinical Pipeline: Continuous clinical trial success is paramount. Companies investing in DENAVIR should prioritize phase III trials with diverse populations to substantiate efficacy and safety claims.

• Regulatory Strategy: Leveraging expedited review pathways and aligning with global health priorities will facilitate faster market access and a competitive edge.

• Pricing and Reimbursement: Early engagement with payers and health authorities is crucial to establish acceptable pricing frameworks.

• Partnerships and Alliances: Collaborations streamline development, manufacturing, and distribution channels, reducing time-to-market.

• Market Expansion: Anticipating future indications and geographic growth enhances long-term revenue potential.

Conclusion

DENAVIR’s market outlook is shaped by growing clinical needs for resistant infections and emerging viral threats. While developmental risks exist, strategic positioning, regulatory advances, and an expanding global health focus create an optimistic pathway for its commercialization. The financial trajectory hinges on successful clinical development, regulatory approval, pricing strategies, and effective market penetration. Investors should monitor progression through clinical phases, regulatory milestones, and partnerships to gauge future profitability.

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Key Takeaways

• DENAVIR addresses critical therapeutic gaps, chiefly antimicrobial resistance and emerging viral infections, positioning it favorably within the global pharmaceutical market.

• The drug’s future financial success depends on successful clinical development, regulatory approval, and strategic stakeholder engagement.

• Early market entry, favorable reimbursement strategies, and geographic expansion are key drivers of revenue growth.

• Potential revenue streams are substantial but contingent upon overcoming clinical, regulatory, and market challenges inherent in novel drug development.

• Strategic alliances and a proactive approach to global health priorities will enhance DENAVIR's market trajectory.

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FAQs

1. What are the primary therapeutic indications for DENAVIR?
DENAVIR is primarily targeted toward resistant bacterial infections and select viral diseases, especially where current treatments face resistance or limited efficacy.

2. How does DENAVIR compare to existing therapies?
While comparative clinical data are pending, DENAVIR’s mechanism aims to overcome resistance issues faced by standard agents, potentially offering improved efficacy and safety profiles.

3. What are the regulatory prospects for DENAVIR?
Given its therapeutic significance, DENAVIR may qualify for expedited pathways such as Fast Track or Breakthrough Therapy designations, contingent upon clinical trial outcomes and unmet need considerations.

4. When can investors expect DENAVIR to reach the market?
Based on typical development timelines, regulatory approval may occur within the next 7–10 years, subject to successful clinical trials and regulatory review.

5. What are the key risks associated with DENAVIR’s market success?
Clinical development failure, regulatory setbacks, competitive advancements, and reimbursement challenges pose substantial risks requiring strategic mitigation.

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References

[1] World Health Organization. "Antimicrobial Resistance." WHO, 2022.
[2] MarketsandMarkets. "Antimicrobial Market by Type, Route of Administration, End User – Global Forecast to 2025." 2020.