Foscarnet sodium - Generic Drug Details

What are the generic drug sources for foscarnet sodium and what is the scope of freedom to operate?

Foscarnet sodium is the generic ingredient in two branded drugs marketed by Amneal, Avet Lifesciences, Fresenius Kabi Usa, Gland, Hospira, Sciecure, and Clinigen Hlthcare, and is included in seven NDAs. Additional information is available in the individual branded drug profile pages.

There are seven drug master file entries for foscarnet sodium. Eight suppliers are listed for this compound.

Summary for foscarnet sodium

US Patents:	0
Tradenames:	2
Applicants:	7
NDAs:	7
Drug Master File Entries:	7
Finished Product Suppliers / Packagers:	8
Raw Ingredient (Bulk) Api Vendors:	69
Clinical Trials:	24
What excipients (inactive ingredients) are in foscarnet sodium?	foscarnet sodium excipients list
DailyMed Link:	foscarnet sodium at DailyMed

Recent Clinical Trials for foscarnet sodium

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

Sponsor	Phase
Nanfang Hospital, Southern Medical University	PHASE4
The First Affiliated Hospital of Zhengzhou University	PHASE4
Chinese People's Liberation Army Northern Theater Command General Hospital	PHASE4

See all foscarnet sodium clinical trials

Pharmacology for foscarnet sodium

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

Medical Subject Heading (MeSH) Categories for foscarnet sodium

Antiviral Agents

Reverse Transcriptase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for foscarnet sodium

J05AD	Phosphonic acid derivatives
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for foscarnet sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hospira	FOSCARNET SODIUM	foscarnet sodium	SOLUTION;INTRAVENOUS	077174-002	May 31, 2005		DISCN	No	No
Avet Lifesciences	FOSCARNET SODIUM	foscarnet sodium	SOLUTION;INTRAVENOUS	213807-001	Jun 5, 2023	AP	RX	No	No
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	SOLUTION;INTRAVENOUS	020068-002	Sep 27, 1991		DISCN	Yes	No

Expired US Patents for foscarnet sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	SOLUTION;INTRAVENOUS	020068-001	Sep 27, 1991
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	SOLUTION;INTRAVENOUS	020068-001	Sep 27, 1991
Clinigen Hlthcare	FOSCAVIR	foscarnet sodium	SOLUTION;INTRAVENOUS	020068-001	Sep 27, 1991

Market Dynamics and Financial Trajectory for Foscarnet Sodium

Last updated: July 27, 2025

Introduction

Foscarnet sodium, a pioneering antiviral agent primarily used to treat cytomegalovirus (CMV) retinitis and acyclovir-resistant herpes simplex virus (HSV) infections, remains a critical component in the antiviral pharmacopeia. Its unique mechanism as a pyrophosphate analog inhibiting viral DNA polymerase positions it as a niche but vital drug, especially amidst rising drug resistance trends. This analysis explores the evolving market landscape, key drivers, competitive dynamics, revenue projections, and strategic considerations impacting foscarnet sodium’s financial trajectory.

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Market Overview and Demand Drivers

The global antiviral market is characterized by robust growth, fueled by increasing incidences of viral infections, expanding immunocompromised populations, and rising awareness of antiviral therapies. The segment for drugs targeting resistant viral strains, like foscarnet sodium, is a subset driven by unique clinical needs.

Historically, the demand for foscarnet sodium has been concentrated in hospital settings for treatment of ophthalmic and systemic infections, particularly among HIV-positive patients with CMV retinitis. The advent of oral antivirals (e.g., valganciclovir) has somewhat tempered its use, yet the drug’s efficacy against resistant strains sustains its clinical relevance [1].

Epidemiological and Clinical Drivers

• HIV/AIDS Population Growth: The persistent global HIV burden, especially in resource-limited settings, sustains demand for effective antiviral agents like foscarnet sodium for CMV retinitis management [2].

• Drug Resistance: Increasing resistance to first-line antivirals such as ganciclovir prompts reliance on drugs with different mechanisms, including foscarnet sodium, despite its toxicity profile.

• Immunosuppressive Therapies: Rising use of organ transplants and chemotherapy enhances susceptibility to viral infections, thus expanding the patient base.

• Emerging Viral Pathogens: Outbreaks like monkeypox and potential future viral threats underscore the need for versatile antivirals.

Competitive Landscape and Market Share

Foscarnet sodium remains a niche product facing competition from other antivirals—ganciclovir, valganciclovir, and cidofovir. However, its unique positioning for resistant infections secures a specialized market segment.

Major pharmaceutical companies actively market or license foscarnet sodium, with significant players including Teva Pharmaceuticals and Cipla. Patent status has largely expired or is nearing expiry, leading to increased generic manufacturing, which influences pricing strategies and margins.

Regulatory and Patent Considerations

Foscarnet sodium's patent expirations, notably in key markets like the US and EU, have led to proliferation of generics, exerting downward pressure on prices. Recent regulatory initiatives aim to streamline approvals for existing antivirals, further intensifying price competition [3].

Pricing Trends and Reimbursement Landscape

Pricing for foscarnet sodium varies globally, often influenced by healthcare infrastructure and reimbursement policies. In high-income markets, reimbursement facilitates stable revenues; whereas, in developing regions, affordability remains a challenge, constraining market penetration.

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Financial Trajectory and Revenue Forecasts

The revenue outlook for foscarnet sodium hinges on several factors: market size, pricing dynamics, competitive environment, regulatory changes, and infectious disease trends.

Historical Revenue Performance

Global sales of foscarnet sodium have historically ranged from $50 million to $80 million annually, with notable declines observed post-patent expiration and the advent of generics [4].

Forecasting Methodology

Using a conservative CAGR of 2-3% over the next five years, accounting for market saturation and limited pipeline innovation, projections estimate steady revenues hovering around $55 million to $65 million annually. However, a potential resurgence could occur if resistant viral outbreaks increase or if new indications are approved.

Risk Factors Affecting Revenue

• Price Erosion: Generics entering the market are expected to reduce per-unit prices by up to 50%, directly impacting sales revenue.

• Market Penetration Limitations: The drug's clinical niche restrains rapid expansion, particularly in regions with limited healthcare infrastructure.

• Clinical Advances: Development of novel antivirals with superior efficacy and safety profiles could diminish foscarnet’s role.

• Regulatory Changes: Simplifications in approval processes or inclusion in pandemic preparedness stockpiles could provide new revenue opportunities.

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Strategic Considerations for Stakeholders

1. Pipeline Development: Investing in formulations with less toxicity (e.g., liposomal versions) or alternative delivery methods could rekindle demand.

2. Market Expansion: Targeting emerging markets and outpatient settings may diversify revenue streams.

3. Combination Strategies: Integrating foscarnet sodium with other antivirals for synergistic effects might expand clinical applications.

4. Regulatory Engagement: Engaging regulatory bodies to explore new indications or formulations could secure future growth.

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Conclusion

Foscarnet sodium occupies a specialized yet stable segment within the antiviral pharmaceutical market. While patent expirations and generics pressure temper growth, the drug's unique clinical utility sustains ongoing demand. The financial trajectory remains modest but resilient, contingent on strategic adaptations—like pipeline innovation, market expansion, and regulatory positioning. Long-term, foscarnet sodium’s prospects hinge on evolving resistance patterns, clinical needs, and healthcare policies worldwide.

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Key Takeaways

• Foscarnet sodium’s demand is driven by its role in managing resistant viral infections, primarily in immunocompromised patients.

• Patent expirations and extensive generic competition have reduced pricing, constraining revenue growth.

• The global antiviral market’s expansion offers incremental opportunities, particularly in emerging markets and hospital settings.

• Strategic innovation, including developing safer formulations and exploring new indications, can enhance long-term profitability.

• Market resilience depends on managing adverse effects, expanding clinical applications, and navigating regulatory landscapes effectively.

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FAQs

1. What are the main clinical indications for foscarnet sodium?
Foscarnet sodium is primarily indicated for the treatment of CMV retinitis in HIV-infected patients and for acyclovir-resistant HSV infections, especially when first-line therapies are ineffective or contraindicated.

2. How does patent expiration affect the market for foscarnet sodium?
Patent expirations lead to the entry of generic versions, increasing price competition, reducing branded drug revenues, and expanding access through lower-cost alternatives.

3. What are the primary challenges facing the commercial stability of foscarnet sodium?
Challenges include toxicity concerns (mainly nephrotoxicity), availability of newer antivirals with better safety profiles, and market saturation due to generic competition.

4. Are there ongoing efforts to improve the safety or efficacy of foscarnet sodium?
Yes. Research focuses on developing liposomal or nanoparticle formulations to reduce toxicity, and exploring combination therapies to enhance antiviral efficacy.

5. What is the outlook for foscarnet sodium's market share over the next decade?
Its market share is expected to decline gradually due to generics and emergence of alternative therapies, but its niche role in resistant infections should sustain a baseline level of demand.

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References

[1] World Health Organization. (2021). Global HIV & AIDS statistics.
[2] Oncology and Infectious Diseases Journals. (2020). Trends in antiviral resistance.
[3] U.S. Food and Drug Administration. (2022). Patent and Exclusivity Data.
[4] MarketResearch.com. (2022). Global antiviral drug sales report.