GANCICLOVIR SODIUM - Generic Drug Details

What are the generic drug sources for ganciclovir sodium and what is the scope of patent protection?

Ganciclovir sodium is the generic ingredient in two branded drugs marketed by Cheplapharm, Am Regent, Custopharm Inc, Endo Operations, Fresenius Kabi Usa, Hikma, Pharmascience Inc, Slate Run Pharma, and Steriscience Speclts, 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:	54
Clinical Trials:	6
Patent Applications:	124
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
National Taiwan University	Phase 2/Phase 3
Huang Pacific Foundation	Phase 2/Phase 3
University of California, San Francisco	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
Endo Operations	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	204950-001	Dec 6, 2016	AP	RX	No	No
Fresenius Kabi Usa	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	090658-001	Jun 21, 2010	AP	RX	No	No
Cheplapharm	CYTOVENE	ganciclovir sodium	INJECTABLE;INJECTION	019661-001	Jun 23, 1989		DISCN	Yes	No
Pharmascience Inc	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	207645-001	Dec 8, 2017	AP	RX	No	Yes
Steriscience Speclts	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	204560-001	Nov 17, 2017		DISCN	No	No
Custopharm Inc	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	212001-001	Jun 20, 2019		DISCN	No	No
Hikma	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	076222-001	Jul 16, 2003	AP	RX	No	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

GANCICLOVIR SODIUM Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ganciclovir Sodium

Market Overview

Ganciclovir sodium, a nucleoside analogue, is a crucial antiviral drug used primarily in the treatment of Cytomegalovirus (CMV) infections. The market for ganciclovir sodium is experiencing significant growth driven by several key factors.

Drivers of Market Growth

Increasing Prevalence of CMV Infections

The rising incidence and prevalence of CMV diseases globally are major drivers propelling the market growth. CMV infections are particularly common among immunocompromised populations, such as organ transplant recipients and individuals with HIV/AIDS. This surge in cases necessitates effective antiviral treatments like ganciclovir sodium, fostering market expansion[3][4].

Expansion of Application Range

Ganciclovir sodium is extensively used in various medical settings, including hospitals, oncology clinics, transplant centers, and government healthcare facilities. Its application extends to preventing CMV infections in patients with weakened immune systems, such as organ transplant recipients and those with AIDS. This broad range of applications contributes to the drug's growing demand[1].

Government Initiatives and Health Awareness

Increased government initiatives and a rise in health awareness are significant factors driving the global ganciclovir sodium market. Public health campaigns and educational programs aimed at raising awareness about CMV infections and their treatments are boosting the market[3][4].

Research and Development

Ongoing research and development efforts aimed at enhancing the efficacy and safety profile of ganciclovir sodium are driving innovation within the market. Pharmaceutical companies are investing in clinical trials and formulation improvements to optimize drug delivery mechanisms and minimize adverse effects, thereby expanding the potential patient population and market reach[1].

Restraints and Challenges

High Cost of Treatment

One of the significant challenges facing the ganciclovir sodium market is the high cost of treatment. This can impede market growth, especially in regions with limited healthcare budgets and access to affordable treatments[4].

Strict Drug Regulatory Systems

The strict drug regulatory system is another hindrance to the market growth. Regulatory approvals and compliance can be time-consuming and costly, which might restrict the market expansion[3].

Financial Trajectory

Market Size and Forecast

The Japan generic ganciclovir sodium market is expected to grow at a Compound Annual Growth Rate (CAGR) of 7.13% from 2024 to 2031. This growth is driven by the increasing demand for effective CMV treatments and the expanding application range of ganciclovir sodium[1].

Global Market Perspective

Globally, the ganciclovir market is also experiencing substantial growth. The global market is estimated to grow significantly during the forecast period, driven by the rising incidence of CMV diseases and increased government initiatives. The global cytomegalovirus treatment market, which includes ganciclovir, is anticipated to reach USD 1,035.16 million by 2032, growing at a CAGR of 6.5% during the forecast period[4].

Revenue and Market Share

The hospital segment holds the largest market share in the Japan generic ganciclovir sodium market, reflecting the drug's extensive use in hospital settings for diverse applications related to CMV infections. Key players such as F. Hoffmann-La Roche AG, Fresenius Kabi, Thermo Fisher Scientific Inc., and others are significant contributors to the market revenue, with ongoing investments in research and development and strategic market positioning[1].

Competitive Landscape

The competitive landscape in the ganciclovir sodium market is characterized by several major pharmaceutical companies. These include F. Hoffmann-La Roche AG, Fresenius Kabi, Thermo Fisher Scientific Inc., Bausch + Lomb, Hikma Pharmaceuticals PLC, and others. These companies are engaged in intense competition, with a focus on financial performance, product innovation, and strategic developments to maintain market share and drive growth[1].

Regional Analysis

Japan Market

In Japan, the generic ganciclovir sodium market is growing rapidly, driven by the rising prevalence of CMV retinitis and congenital CMV infection, as well as increased initiatives to raise awareness about these conditions[1].

Global Market

Regionally, the global ganciclovir market is dominated by North America and Europe, with the Asia-Pacific region expected to record higher growth rates during the forecast period. The increasing incidence of CMV infections and growing healthcare expenditure in these regions are key factors driving the market growth[3].

Technological and Innovative Trends

Enhanced Diagnostic Facilities

The market is also driven by better diagnostic facilities and increased demand for personalized medicines. Advanced diagnostic tools enhance the detection rates of CMV infections, leading to a higher demand for effective treatments like ganciclovir sodium[3].

New Treatment Options

New treatment options and technological breakthroughs are anticipated to highlight new avenues for market growth. Ongoing research and development efforts are focused on improving the efficacy and safety of ganciclovir sodium, which is expected to further bolster the market[3][4].

Key Takeaways

• The ganciclovir sodium market is driven by the increasing prevalence of CMV infections and the expanding application range of the drug.
• Government initiatives and health awareness campaigns are significant drivers of market growth.
• High treatment costs and strict drug regulatory systems are key challenges facing the market.
• The market is expected to grow at a CAGR of 7.13% in Japan and 6.5% globally during the forecast period.
• Key players are investing heavily in research and development to enhance the drug's efficacy and safety.

FAQs

What is the primary use of ganciclovir sodium?

Ganciclovir sodium is primarily used in the treatment of Cytomegalovirus (CMV) infections, particularly in immunocompromised patients such as organ transplant recipients and individuals with HIV/AIDS.

What are the key drivers of the ganciclovir sodium market?

The key drivers include the rising incidence and prevalence of CMV diseases, expansion of the application range, government initiatives, and increased health awareness.

Which segment holds the largest market share in the Japan generic ganciclovir sodium market?

The hospital segment holds the largest market share in the Japan generic ganciclovir sodium market.

What are the challenges facing the ganciclovir sodium market?

The high cost of treatment and strict drug regulatory systems are significant challenges facing the market.

Who are the major players in the ganciclovir sodium market?

Major players include F. Hoffmann-La Roche AG, Fresenius Kabi, Thermo Fisher Scientific Inc., Bausch + Lomb, and Hikma Pharmaceuticals PLC.

Sources

1. Verified Market Research: Japan Generic Ganciclovir Sodium Market Size, Forecast[1]
2. Northwestern University: Reports Required by Government Auditing Standards and OMB 2[2]
3. Verified Market Research: Ganciclovir Market Size, Share, Trends, Analysis, Scope & Forecast[3]
4. Polaris Market Research: Cytomegalovirus Treatment Market Size, Share, Global Analysis[4]
5. Cognitive Market Research: Global Ganciclovir Sodium Market Report 2024 Edition[5]