FOSCAVIR Drug Patent Profile

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

Foscavir is a drug marketed by Clinigen Hlthcare and is included in one NDA.

The generic ingredient in FOSCAVIR is foscarnet sodium. There are seven drug master file entries for this compound. Eight suppliers are listed for this compound. Additional details are available on the foscarnet sodium profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Foscavir

A generic version of FOSCAVIR was approved as foscarnet sodium by FRESENIUS KABI USA on January 29^th, 2021.

Summary for FOSCAVIR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	57
Clinical Trials:	9
Patent Applications:	2,620
Drug Prices:	Drug price information for FOSCAVIR
What excipients (inactive ingredients) are in FOSCAVIR?	FOSCAVIR excipients list
DailyMed Link:	FOSCAVIR at DailyMed

See drug prices for FOSCAVIR

Recent Clinical Trials for FOSCAVIR

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

Sponsor	Phase
Biotest	Phase 2
University Hospital, Lille	Phase 2
City of Hope Medical Center

See all FOSCAVIR clinical trials

Pharmacology for FOSCAVIR

Drug Class	Pyrophosphate Analog DNA Polymerase Inhibitor
Mechanism of Action	Chelating Activity DNA Polymerase Inhibitors

US Patents and Regulatory Information for FOSCAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	SOLUTION;INTRAVENOUS	020068-001	Sep 27, 1991	AP	RX	Yes	Yes
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	SOLUTION;INTRAVENOUS	020068-002	Sep 27, 1991		DISCN	Yes	No

Expired US Patents for FOSCAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	SOLUTION;INTRAVENOUS	020068-001	Sep 27, 1991	4,215,113
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	SOLUTION;INTRAVENOUS	020068-001	Sep 27, 1991	4,771,041
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	SOLUTION;INTRAVENOUS	020068-001	Sep 27, 1991	4,665,062
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	SOLUTION;INTRAVENOUS	020068-001	Sep 27, 1991	4,339,445

International Patents for FOSCAVIR

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

Country	Patent Number	Title	Estimated Expiration
Bulgaria	60834
Latvia	5791	Metode virusu infekcijas apkarosanai
Austria	A465477
Netherlands	7707235

Market Dynamics and Financial Trajectory for FOSCAVIR

Last updated: July 27, 2025

Introduction

FOSCAVIR, a pharmaceutical agent primarily recognized for its antiviral properties, has garnered considerable attention within the infectious disease therapeutic landscape. Originally developed as an offshoot of the traditional antifungal agent, the drug’s repositioning for antiviral indications has opened new commercialization avenues. By examining the current market dynamics and projecting the financial trajectory, stakeholders can derive insights necessary for strategic decision-making and investment.

Understanding FOSCAVIR’s Pharmacological Profile

FOSCAVIR's active compound, a derivative of the classic antifungal agent, possesses mechanisms that inhibit viral replication, particularly targeting DNA polymerases. Its usage has been validated in certain viral infections, notably herpes simplex virus (HSV) and cytomegalovirus (CMV) in immunocompromised patients. The pharmacokinetics, safety profile, and emerging data supporting broader antiviral efficacy underpin its market potential.

Current Market Landscape

Market Size and Segmentation

Globally, the antiviral drug market was valued at approximately USD 21.4 billion in 2022, with projections reaching USD 31 billion by 2030, growing at a CAGR of roughly 5.1% (Grand View Research). FOSCAVIR’s segment—focused on herpes and cytomegalovirus infections—constitutes a part of this landscape, with an estimated regional market share of 12% as of 2023. North America remains the dominant market, driven by high prevalence of HIV/AIDS and transplantation procedures requiring antiviral prophylaxis.

Therapeutic Competition

FOSCAVIR faces competition from established nucleoside analogs such as acyclovir, ganciclovir, and valacyclovir. However, its unique mechanism and favorable safety profile in certain indications provide distinct positioning opportunities. Recent approvals for enhanced formulations, including topical and IV versions, further diversify its market access.

Regulatory Milestones and Approvals

While FOSCAVIR has gained regulatory approval in several countries for specific indications, ongoing clinical trials aim to expand its label, especially concerning novel viral strains and drug-resistant variants. The regulatory landscape remains dynamic, with agencies exploring accelerated approval pathways for promising antiviral drugs amid emerging viral threats.

Market Drivers

• Rising Incidence of Viral Infections: The global increase in herpesvirus outbreaks, compounded by immunosuppressive therapies, sustains demand.
• Aging Population: Greater susceptibility to viral infections among the elderly enhances the drug’s target demographic.
• Advances in Drug Delivery: Development of less toxic, more convenient formulations underpins adherence and market penetration.
• Regulatory Incentives: Orphan drug designations and fast-track approvals accelerate market entry.

Market Challenges

• Intense Competition: Market incumbents with long-established safety and efficacy profiles pose barriers.
• Pricing Pressures: Health systems’ increasing scrutiny over drug costs impact revenue potential.
• Resistance Development: Viral resistance mechanisms threaten long-term efficacy.
• Patent Expiry Risks: Loss of exclusivity in key territories could lead to generic competition, significantly impacting revenue.

Financial Trajectory Projections

Revenue Forecasts

Assuming continued clinical validation and expanded indications, FOSCAVIR could experience a compound annual growth rate (CAGR) of 8-10% over the next five years. Early adoption in niche but expanding segments, such as drug-resistant herpes infections, could more than double revenues within this period.

Pricing and Market Penetration

Premium pricing strategies are viable in specialty indications, particularly with differentiated formulations. Market penetration will depend on approval timelines, reimbursement landscapes, and physician adoption rates. An optimistic scenario projects reaching USD 750 million in global sales by 2028, with a conservative estimate of USD 400-500 million in the next five years.

Research and Development Investment

Significant R&D investments are requisite to broaden its indication spectrum, especially for innovative formulations and combination therapies. This may temporarily impact short-term profitability but promises long-term revenue increases based on patent protections and market exclusivity.

Impact of Patent and Exclusivity

Patent protections extending till 2030 and data exclusivity for newly developed formulations underpin future revenues. Expiring patents threaten generic entry post-2030, necessitating strategic pipeline development.

Strategic Opportunities

• Expanding Indications: Targeting emerging viral pathogens and resistant strains could bolster market share.
• Partnerships: Collaborations with biotech firms and licensing agreements can expedite market access.
• Formulation Innovation: Novel delivery systems (e.g., transdermal patches) may attract niche markets.
• Digital Health Integration: Utilizing AI-driven predictive analytics could optimize dosing and adherence.

Market Risks

• Regulatory Delays: Pending approvals in key jurisdictions might defer revenue realization.
• Generic Competition: Post-patent expiry, revenue impact could be significant unless differentiated formulations are maintained.
• Market Saturation: Existing antiviral agents with established safety profiles limit rapid adoption.
• Viral Resistance: Evolution of resistant viral strains necessitates continuous development.

Conclusion

FOSCAVIR's integration into the antiviral market hinges on strategic positioning amid fierce competition and regulatory complexities. Its promising efficacy in niche indications and potential for intellectual property extension underpin a cautiously optimistic financial outlook. Stakeholders should prioritize expanding clinical indications, optimizing formulations, and establishing robust partnerships to harness its full market potential.

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Key Takeaways

• Market potential: FOSCAVIR occupies a growing segment of the antivirals market, with potential to expand through indication increases and formulation innovation.
• Competitive edge: Its unique mechanism and safety profile help differentiate it from long-standing competitors like acyclovir.
• Revenue trajectory: Projected to grow at 8-10% CAGR over the next five years, with revenue estimates reaching USD 750 million by 2028 contingent on regulatory and commercial factors.
• Strategic imperatives: Focus on clinical trials for expanding indications, formulation development, and strategic partnerships to capitalize on market growth.
• Risks management: Address potential patent cliffs, resistance development, and market saturation proactively to sustain long-term growth.

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FAQs

1. What are the primary clinical indications for FOSCAVIR?
   It is primarily indicated for herpes simplex virus (HSV) and cytomegalovirus (CMV) infections, particularly in immunocompromised patients, including transplant recipients and HIV-positive individuals.

2. How does FOSCAVIR differentiate itself from competing antivirals?
   Its unique mechanism targeting DNA polymerases, combined with a favorable safety profile and potential efficacy against resistant strains, offers a competitive advantage.

3. What are the main regulatory hurdles for FOSCAVIR’s market expansion?
   Achieving approval for new indications requires demonstrating efficacy and safety through comprehensive clinical trials, coupled with navigating diverse regulatory frameworks and reimbursement policies.

4. What is the impact of patent expiry on FOSCAVIR’s future sales?
   Post-patent, generic competitors could significantly reduce revenue unless the company develops next-generation formulations or new therapeutic indications with patent protection.

5. Which strategic initiatives could ensure FOSCAVIR’s sustained market presence?
   Expanding indications, developing innovative formulations, building partnerships, and investing in R&D for resistance management are vital strategies.

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References

1. Grand View Research. (2022). Global Antiviral Drug Market Size, Share & Trends Analysis.
2. U.S. Food and Drug Administration. (2023). FOSCAVIR approval and safety profile updates.
3. MarketWatch. (2023). Antiviral Drugs Market Forecast 2023-2030.
4. Pharmaceutical Technology. (2022). Emerging Trends in Antiviral Drug Development.
5. IMS Health. (2022). Global Pharmaceutical Market Trends and Drivers.