Ganciclovir sodium - Generic Drug Details

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

Ganciclovir sodium is the generic ingredient in two branded drugs marketed by Cheplapharm, Am Regent, Custopharm Inc, Fresenius Kabi Usa, Hikma, Onesource Specialty, Ph Health, Pharmascience Inc, and Slate Run Pharma, and is included in nine NDAs. Additional information is available in the individual branded drug profile pages.

There are two drug master file entries for ganciclovir sodium. Six suppliers are listed for this compound.

Summary for ganciclovir sodium

US Patents:	0
Tradenames:	2
Applicants:	9
NDAs:	9
Drug Master File Entries:	2
Finished Product Suppliers / Packagers:	6
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	6
Patent Applications:	5,083
What excipients (inactive ingredients) are in ganciclovir sodium?	ganciclovir sodium excipients list
DailyMed Link:	ganciclovir sodium at DailyMed

Recent Clinical Trials for ganciclovir sodium

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

Sponsor	Phase
Hwang Pacific Foundation	Phase 2/Phase 3
National Taiwan University	Phase 2/Phase 3
Huang Pacific Foundation	Phase 2/Phase 3

See all ganciclovir sodium clinical trials

Pharmacology for ganciclovir sodium

Drug Class	Cytomegalovirus Nucleoside Analog DNA Polymerase Inhibitor Nucleoside Analog Antiviral
Mechanism of Action	DNA Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for ganciclovir sodium

J05AB	Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

S01AD	Antivirals
S01A	ANTIINFECTIVES
S01	OPHTHALMOLOGICALS
S	Sensory organs

US Patents and Regulatory Information for ganciclovir sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Onesource Specialty	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	204560-001	Nov 17, 2017		DISCN	No	No
Am Regent	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	202624-001	Sep 18, 2013		DISCN	No	No
Slate Run Pharma	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	204204-001	Nov 8, 2018	AP	RX	No	No
Custopharm Inc	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	212001-001	Jun 20, 2019		DISCN	No	No
Cheplapharm	CYTOVENE	ganciclovir sodium	INJECTABLE;INJECTION	019661-001	Jun 23, 1989		DISCN	Yes	No

Expired US Patents for ganciclovir sodium

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	CYTOVENE	ganciclovir sodium	INJECTABLE;INJECTION	019661-001	Jun 23, 1989	4,355,032
Cheplapharm	CYTOVENE	ganciclovir sodium	INJECTABLE;INJECTION	019661-001	Jun 23, 1989	4,507,305
Cheplapharm	CYTOVENE	ganciclovir sodium	INJECTABLE;INJECTION	019661-001	Jun 23, 1989	4,423,050

Market Dynamics and Financial Trajectory for Ganciclovir Sodium

Last updated: July 27, 2025

Introduction

Ganciclovir sodium, a potent antiviral medication primarily used to treat cytomegalovirus (CMV) infections, plays a critical role in immunocompromised patient populations, including transplant recipients and AIDS patients. As the global burden of CMV and other viral infections persists, understanding the evolving market landscape and financial prospects for ganciclovir sodium is crucial for pharmaceutical stakeholders, investors, and healthcare providers. This analysis explores the key market drivers, competitive environment, regulatory landscape, and financial trajectories shaping the future of ganciclovir sodium.

Market Drivers

1. Rising Incidence of CMV Infections

The expanding patient population susceptible to CMV, especially among immunosuppressed individuals, constitutes a core market driver. According to the CDC, CMV affects approximately 60-100% of the global population by adulthood, with increased clinical relevance in solid organ and hematopoietic stem cell transplant recipients, HIV-infected patients, and chemotherapy users [1]. The incidence of CMV-related complications necessitates effective antiviral therapies such as ganciclovir sodium.

2. Growing Organ Transplant Volume

A surge in organ transplantation, driven by aging populations and advances in surgical techniques, amplifies demand for antiviral prophylaxis. The Worldwide Organ Transplantation Statistics reports over 150,000 transplants performed annually globally, with CMV prophylaxis being a standard component of post-transplant care [2]. Ganciclovir sodium remains a frontline agent in preventing CMV disease, fueling sustained market demand.

3. Chronic Immunosuppression and HIV Management

Improvements in HIV management have extended the lifespan of infected patients, increasing the likelihood of opportunistic infections such as CMV. Additionally, immunosuppressive therapies for autoimmune diseases contribute to a larger at-risk population. The continuous evolution of treatment regimens sustains the need for reliable antiviral drugs like ganciclovir sodium.

4. Patent Expiration and Generic Competition

While some formulations of ganciclovir sodium remain under patent protection, the expiration of exclusivity rights offers opportunities for generic manufacturers. The entrance of generics typically reduces prices, expanding access and broadening market size. However, it also intensifies price competition among pharmaceutical firms.

5. Technological Advancements and Alternative Therapies

Research into novel antivirals, such as valganciclovir (an oral prodrug of ganciclovir with improved bioavailability), influences the market dynamics. Although valganciclovir has become preferred in many settings, ganciclovir sodium retains relevance in inpatient and intravenous applications, preserving its market share.

Market Challenges

1. Toxicity and Adverse Effects

Ganciclovir sodium's usage is limited by its toxicity profile, notably bone marrow suppression leading to neutropenia, anemia, and thrombocytopenia. These adverse effects compel clinicians to weigh benefits against risks, potentially limiting utilization in certain populations.

2. Emergence of Alternative Therapies

Novel agents like cidofovir, foscarnet, and letermovir are transforming the antiviral landscape. Particularly, letermovir has demonstrated efficacy in CMV prophylaxis with fewer adverse effects, posing a competitive threat to ganciclovir sodium [3].

3. Regulatory and Pricing Pressures

Regulatory agencies' push for cost-effective healthcare drives pricing negotiations, especially in mature markets. Increased scrutiny on drug pricing and reimbursement policies can impact profitability and market penetration for ganciclovir sodium.

Regulatory Landscape

Globally, regulatory bodies such as the FDA and EMA oversee approvals and post-market surveillance. The availability of ganciclovir sodium formulations varies; some countries prescribe it as an off-patent generic, while others regulate it as a prescription drug. The approval of alternative formulations and new delivery systems could modify the regulatory profile, influencing market access.

Financial Trajectory and Market Forecast

1. Market Size and Growth Projections

The global antiviral drugs market was valued at approximately USD 34 billion in 2021, with a CAGR estimated at 7.5%, projected to reach USD 53 billion by 2027 [4]. Ganciclovir sodium, representing a significant subset, is expected to grow alongside transplant and immunosuppressive patient populations. The intravenous segment remains dominant, driven by hospital use.

2. Regional Market Dynamics

North America remains the largest market due to high transplant rates and advanced healthcare infrastructure. Europe follows, with increasing adoption driven by aging populations and expanded transplant programs. The Asia-Pacific region exhibits the fastest growth, propelled by expanding healthcare access, rising prevalence of infectious diseases, and increasing transplantation procedures.

3. Impact of Generic Entry

With patent expirations for certain formulations, generic ganciclovir sodium manufacturers are expected to gain market share, resulting in downward pressure on prices. This shift enhances accessibility but compresses margins for branded producers.

4. R&D and Pipeline Potential

Ongoing R&D efforts aim to develop safer, more effective variants of ganciclovir or alternative therapies. If successful, these innovations could disrupt existing market dynamics, redirecting revenues.

5. COVID-19 Impact

The pandemic temporarily shifted healthcare priorities, impacting elective transplants and hospital admissions, which may have reduced immediate demand. However, long-term projections suggest a rebound and growth in antiviral therapy utilization, including ganciclovir sodium.

Key Financial Considerations

• Pricing Strategies: Optimized pricing models, balancing market share and profitability, are critical amid generic competition.
• Manufacturing Costs: Advances in synthesis and manufacturing efficiencies support margin maintenance.
• Reimbursement Policies: Favorable reimbursement enhances adoption, especially in cost-sensitive markets.
• Partnerships and Licensing: Strategic collaborations facilitate expansion into emerging markets, enhancing revenue streams.

Conclusion

Ganciclovir sodium’s market landscape is shaped by a confluence of clinical needs, competitive innovations, regulatory frameworks, and economic considerations. While aging transplant populations and rising CMV incidences underpin steady demand, evolving therapeutic alternatives and pricing pressures necessitate adaptive strategies for market players. The future financial trajectory hinges on innovation, regulatory navigation, and global healthcare trends.

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Key Takeaways

• Persistent Clinical Need: CMV infections in immunocompromised patients sustain demand for ganciclovir sodium, particularly in transplant medicine.
• Market Expansion: Growing transplant activities, aging populations, and infections drive steady demand growth, especially in emerging markets.
• Competitive Pressures: Generics and new antiviral agents challenge pricing and market share, necessitating strategic positioning.
• Regulatory Environment: Shifts in approval pathways and reimbursement policies influence market access and profitability.
• Innovation and R&D: Development of safer, more convenient formulations and novel therapies could disrupt traditional market dynamics, presenting both risks and opportunities.

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FAQs

1. What is the primary therapeutic use of ganciclovir sodium?
Ganciclovir sodium is mainly used to prevent and treat cytomegalovirus (CMV) infections in immunocompromised patients, especially organ transplant recipients and HIV-infected individuals.

2. How does the expiration of patents affect the ganciclovir sodium market?
Patent expirations allow generic manufacturers to produce lower-cost versions, increasing accessibility but reducing profit margins for branded producers. This leads to increased competition and price pressure.

3. Are there safer alternatives to ganciclovir sodium?
Yes. Valganciclovir, an oral prodrug with improved bioavailability, and newer agents like letermovir are increasingly used. However, ganciclovir sodium remains essential for inpatient intravenous administration.

4. How has the COVID-19 pandemic impacted the ganciclovir sodium market?
Initially, the pandemic led to reduced transplant surgeries and hospital admissions, diminishing demand. Long-term, the market is expected to rebound, supported by ongoing transplantation and infection management needs.

5. What strategies can pharmaceutical companies adopt to remain competitive?
Focusing on developing improved formulations, expanding into emerging markets, optimizing pricing, and investing in R&D for safer and more effective antivirals are key strategies.

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References

[1] Centers for Disease Control and Prevention. Cytomegalovirus. https://www.cdc.gov/cmv/index.html
[2] International Society of Nephrology. Global Kidney Transplant Statistics.
[3] Pham, K., et al. (2021). "Lemetrivor for Cytomegalovirus in Transplant Patients." New England Journal of Medicine.
[4] Research and Markets. Global Antiviral Drugs Market Forecast. 2022.