GANCICLOVIR - Generic Drug Details

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

Ganciclovir is the generic ingredient in six branded drugs marketed by Roche Palo, Ranbaxy Labs Ltd, Bausch And Lomb, Exela Pharma, Cheplapharm, Am Regent, Custopharm Inc, Endo Operations, Fresenius Kabi Usa, Hikma, Pharmascience Inc, Slate Run Pharma, and Steriscience Speclts, and is included in fourteen NDAs. There is one patent protecting this compound. Additional information is available in the individual branded drug profile pages.

There are twenty-seven drug master file entries for ganciclovir. Two suppliers are listed for this compound.

Summary for GANCICLOVIR

US Patents:	1
Tradenames:	6
Applicants:	13
NDAs:	14
Drug Master File Entries:	27
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	151
Clinical Trials:	152
Patent Applications:	5,861
Drug Prices:	Drug price trends for GANCICLOVIR
What excipients (inactive ingredients) are in GANCICLOVIR?	GANCICLOVIR excipients list
DailyMed Link:	GANCICLOVIR at DailyMed

See drug prices for GANCICLOVIR

Recent Clinical Trials for GANCICLOVIR

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

Sponsor	Phase
Merck Sharp & Dohme LLC	Early Phase 1
Virginia Commonwealth University	Early Phase 1
New York Medical College	Phase 1/Phase 2

See all GANCICLOVIR clinical trials

Pharmacology for GANCICLOVIR

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

Medical Subject Heading (MeSH) Categories for GANCICLOVIR

Antiviral Agents

Anatomical Therapeutic Chemical (ATC) Classes for GANCICLOVIR

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

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Slate Run Pharma	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	204204-001	Nov 8, 2018	AP	RX	No	No
Pharmascience Inc	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	207645-001	Dec 8, 2017	AP	RX	No	Yes
Ranbaxy Labs Ltd	GANCICLOVIR	ganciclovir	CAPSULE;ORAL	076457-002	Jun 27, 2003		DISCN	No	No
Hikma	GANCICLOVIR SODIUM	ganciclovir sodium	INJECTABLE;INJECTION	076222-001	Jul 16, 2003	AP	RX	No	No
Bausch And Lomb	ZIRGAN	ganciclovir	GEL;OPHTHALMIC	022211-001	Sep 15, 2009		RX	Yes	Yes

Expired US Patents for GANCICLOVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-002	Dec 12, 1997	4,355,032
Bausch And Lomb	VITRASERT	ganciclovir	IMPLANT;IMPLANTATION	020569-001	Mar 4, 1996	5,378,475
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-001	Dec 22, 1994	4,355,032
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-002	Dec 12, 1997	4,507,305
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-002	Dec 12, 1997	4,423,050

EU/EMA Drug Approvals for GANCICLOVIR

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Dr. Gerhard Mann, Chem.-Pharm. Fabrik GmbH..	Vitrasert Implant	ganciclovir	EMEA/H/C/000120 The Vitrasert implant is indicated for the local treatment of cytomegalovirus (CMV) retinitis in patients with acquired immunodeficiency syndrome (AIDS) (See 4.4. Special warnings and special precautions for use).	Withdrawn	no	no	no	1997-03-18

GANCICLOVIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Ganciclovir

Introduction to Ganciclovir

Ganciclovir is an antiviral medication primarily used in the treatment of cytomegalovirus (CMV) infections, particularly in patients with compromised immune systems such as those with AIDS or organ transplant recipients. The market for ganciclovir is driven by several key factors, which are crucial in understanding its financial trajectory.

Market Growth Drivers

Increasing Incidence of CMV Infections

The rising incidence and prevalence of CMV diseases globally are significant drivers of the ganciclovir market. CMV infections are more common among immunocompromised populations, including organ transplant recipients and individuals with HIV/AIDS. This increase in cases necessitates the use of effective antiviral treatments like ganciclovir, thereby driving market growth[3][4].

Government Initiatives and Health Awareness

Government initiatives and an increase in health awareness are also propelling the market. Public health campaigns and increased funding for healthcare, especially for infectious diseases, contribute to the demand for ganciclovir. Better diagnostic facilities and the growing demand for personalized medicines further augment the market[1][4].

Transplantation Activities

The surge in organ and stem cell transplantation activities is another key driver. As transplantation procedures become more common, the incidence of CMV infections among recipients increases, leading to a higher demand for antiviral drugs like ganciclovir and valganciclovir[3].

Market Segments

By End User

The ganciclovir market is segmented based on end users, including patients with AIDS, those undergoing organ transplants, and those with malignant neoplasms. These segments are critical as CMV infections are more prevalent in these patient groups[1].

By Geography

Geographically, the market is divided into North America, Europe, Asia Pacific, and the rest of the world. North America and Europe currently hold major shares in the global ganciclovir market, while the Asia Pacific region is expected to record higher growth rates in the forecast period[1][2].

By Application

Ganciclovir is available in various forms such as capsules, injections, tablets, and eye drops. The market is segmented based on these applications, with each form catering to different treatment needs and patient preferences[2].

Financial Trajectory

Market Size and Forecast

The ganciclovir market has been growing at a moderate pace over the last few years and is expected to continue this trend. The market is estimated to grow significantly from 2020 to 2027, driven by the factors mentioned above. By 2032, the cytomegalovirus treatment market, which includes ganciclovir, is projected to reach USD 1,035.16 million, growing at a CAGR of 6.5% during the forecast period[1][3][4].

Revenue Projections

The ganciclovir API market, specifically, is anticipated to expand significantly from 2023 to 2031. The market size is expected to reach USD billion by the end of 2031, exhibiting strong growth rates during the forecast period[2].

Cost-Effectiveness

Studies have shown that oral ganciclovir is a cost-saving alternative to intravenous ganciclovir for the maintenance treatment of CMV retinitis in AIDS patients. The mean cost of treatment for oral ganciclovir was significantly lower at $4,938 compared to $8,587 for intravenous ganciclovir, highlighting the economic benefits of oral administration[5].

Challenges and Restraints

High Drug Pricing

Despite the growth drivers, the ganciclovir market faces challenges such as high drug pricing, which can restrict market growth. The cost of antiviral treatments, especially for long-term use, can be prohibitive for many patients[1][3].

Regulatory Hurdles

Strict drug regulatory systems also pose a challenge. Regulatory approvals and compliance can be time-consuming and costly, potentially hindering the market's growth[1].

Competitive Landscape

The ganciclovir market is competitive, with several key players such as Roche, Luitpold, Bausch & Lomb, Fresenius Kabi, and others. These companies are involved in various strategies including research and development, product launches, and mergers and acquisitions to maintain their market position[1][2].

Key Players and Their Strategies

• Roche: Known for its extensive portfolio of pharmaceutical products, Roche plays a significant role in the ganciclovir market through its brand Cytovene.
• Luitpold: This company, along with others like Bausch & Lomb and Fresenius Kabi, contributes to the market through their product offerings and strategic developments[1].

Market Outlook

The market outlook for ganciclovir is positive, driven by increasing healthcare expenditure, rising incidence of CMV infections, and advancements in antiviral therapies. The market is expected to benefit from ongoing research and development, international collaborations, and government initiatives aimed at combating infectious diseases[3].

Technological Breakthroughs

New treatment options and technological breakthroughs are anticipated to highlight new avenues for market growth. Innovations in drug delivery systems and the development of novel antiviral agents will continue to shape the market's future[1][4].

Key Takeaways

• The ganciclovir market is driven by the increasing incidence of CMV infections, government initiatives, and rising healthcare expenditure.
• The market is segmented by end users, geography, and application forms.
• Despite growth drivers, the market faces challenges such as high drug pricing and strict regulatory systems.
• Key players are investing in research and development and strategic market approaches to maintain their position.
• The market is expected to grow significantly over the forecast period, driven by technological advancements and increasing demand for antiviral treatments.

FAQs

What is the primary use of ganciclovir?

Ganciclovir is primarily used in the treatment of cytomegalovirus (CMV) infections, especially in patients with compromised immune systems.

Which regions are expected to drive the growth of the ganciclovir market?

North America and Europe currently hold major shares, but the Asia Pacific region is expected to record higher growth rates in the forecast period.

What are the main challenges facing the ganciclovir market?

High drug pricing and strict drug regulatory systems are significant challenges that could restrict market growth.

How does the cost of oral ganciclovir compare to intravenous ganciclovir?

Oral ganciclovir is a cost-saving alternative to intravenous ganciclovir, with a mean cost of $4,938 compared to $8,587 for intravenous administration.

Which companies are key players in the ganciclovir market?

Key players include Roche, Luitpold, Bausch & Lomb, Fresenius Kabi, and several others involved in the production and distribution of ganciclovir.

Cited Sources:

1. Verified Market Research: Ganciclovir Market Size, Share, Trends, Analysis, Scope & Forecast.
2. Market Research Intellect: Global Ganciclovir API Market Size, Scope And Forecast Report.
3. Polaris Market Research: Cytomegalovirus Treatment Market Size, Share, Global Analysis.
4. BCC Research: Global Ganciclovir Market By Segments, By Geography.
5. PubMed: An economic evaluation of oral compared with intravenous ganciclovir for the maintenance treatment of AIDS patients with newly diagnosed CMV retinitis.