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Last Updated: December 22, 2024

GANCICLOVIR SODIUM Drug Patent Profile


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

Ganciclovir Sodium is a drug marketed by Am Regent, Custopharm Inc, Endo Operations, Fresenius Kabi Usa, Hikma, Pharmascience Inc, Slate Run Pharma, and Steriscience Speclts. and is included in eight NDAs.

The generic ingredient in GANCICLOVIR SODIUM is ganciclovir sodium. There are twenty-seven drug master file entries for this compound. Six suppliers are listed for this compound. Additional details are available on the ganciclovir sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Ganciclovir Sodium

A generic version of GANCICLOVIR SODIUM was approved as ganciclovir sodium by HIKMA on July 16th, 2003.

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Drug patent expirations by year for GANCICLOVIR SODIUM
Recent Clinical Trials for GANCICLOVIR SODIUM

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

SponsorPhase
Chulalongkorn UniversityPhase 2/Phase 3
Francis I. Proctor FoundationPhase 2/Phase 3
Khon Kaen UniversityPhase 2/Phase 3

See all GANCICLOVIR SODIUM clinical trials

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
Am Regent GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 202624-001 Sep 18, 2013 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Slate Run Pharma GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 204204-001 Nov 8, 2018 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Fresenius Kabi Usa GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 090658-001 Jun 21, 2010 AP RX No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Steriscience Speclts GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 204560-001 Nov 17, 2017 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Custopharm Inc GANCICLOVIR SODIUM ganciclovir sodium INJECTABLE;INJECTION 212001-001 Jun 20, 2019 DISCN No No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

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]

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