CYTOVENE Drug Patent Profile

Which patents cover Cytovene, and what generic alternatives are available?

Cytovene is a drug marketed by Roche Palo and Cheplapharm and is included in two NDAs.

The generic ingredient in CYTOVENE 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 Cytovene

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

Summary for CYTOVENE

US Patents:	0
Applicants:	2
NDAs:	2
Raw Ingredient (Bulk) Api Vendors:	150
Clinical Trials:	10
Drug Prices:	Drug price information for CYTOVENE
What excipients (inactive ingredients) are in CYTOVENE?	CYTOVENE excipients list
DailyMed Link:	CYTOVENE at DailyMed

See drug prices for CYTOVENE

Recent Clinical Trials for CYTOVENE

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

Sponsor	Phase
Fred Hutchinson Cancer Research Center	Phase 3
National Heart, Lung, and Blood Institute (NHLBI)	Phase 3
National Institute of Allergy and Infectious Diseases (NIAID)	Phase 1

See all CYTOVENE clinical trials

US Patents and Regulatory Information for CYTOVENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-001	Dec 22, 1994		DISCN	Yes	No
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-002	Dec 12, 1997		DISCN	Yes	No
Cheplapharm	CYTOVENE	ganciclovir sodium	INJECTABLE;INJECTION	019661-001	Jun 23, 1989		DISCN	Yes	No

Expired US Patents for CYTOVENE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	CYTOVENE	ganciclovir sodium	INJECTABLE;INJECTION	019661-001	Jun 23, 1989	4,423,050
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-002	Dec 12, 1997	4,355,032
Cheplapharm	CYTOVENE	ganciclovir sodium	INJECTABLE;INJECTION	019661-001	Jun 23, 1989	4,355,032
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
Cheplapharm	CYTOVENE	ganciclovir sodium	INJECTABLE;INJECTION	019661-001	Jun 23, 1989	4,507,305

EU/EMA Drug Approvals for CYTOVENE

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

International Patents for CYTOVENE

See the table below for patents covering CYTOVENE around the world.

Country	Patent Number	Title	Estimated Expiration
Germany	3266644
Romania	84860	PROCEDEU PENTRU PREPARAREA 9-(1, 3-DIHIDROXI-2-PROPEXIMETIL)-GUANINEI (PROCESS FOR THE PREPARATION OF 9-(1, 3-DIHYDROXY-2-PROPOXYMETHYL)-GUANINE)
German Democratic Republic	213218	VERFAHREN ZUR HERSTELLUNG VON 9-(1,3-DIHYDROXY-2-PROPOXYMETHYL)-GUANINDERIVATEN
Australia	8389282
Denmark	504183
German Democratic Republic	203052	VERFAHREN ZUR HERSTELLUNG VON 9-(1,3-DIHYDROXY-2-PROPOXY-METHYL)-GUANIN, DESSEN SALZEN UND BESTIMMTEN BENZYLDERIVATEN DESSELBEN

Supplementary Protection Certificates for CYTOVENE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0694547	2002/028	Ireland		PRODUCT NAME: VALGANCICLOVIR (2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)- METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE) AND PHARMACEUTICALLY ACCEPTABLE SALTS THEREOF; NAT REGISTRATION NO/DATE: 50/150/1 20020913; FIRST REGISTRATION NO/DATE: NL 25992 20010920; PAEDIATRIC INVESTIGATION PLAN: P/0220/2013
0694547	SPC/GB02/027	United Kingdom		PRODUCT NAME: 2-(2-AMINO-1,6-DIHYDRO-6-OXO-PURIN-9-YL)-METHOXY-3-HYDROXY-1-PROPANYL-L-VALINATE HYDROCHLORIDE (VALGANCICLOVIR HYDROCHLORIDE); REGISTERED: NL RVG 25992 20010920; UK PL 00031/0599 20020425
0694547	03C0003	France		PRODUCT NAME: VALGANCICLOVIR AINSI QUE SES SELS PHARMACEUTIQUEMENT ACCEPTABLES ET EN PARTICULIER LE CHLORHYDRATE; NAT. REGISTRATION NO/DATE: NL 27380 20021016; FIRST REGISTRATION: NL - RVG 25 992 20010920
0694547	C300071	Netherlands		PRODUCT NAME: VALGANCICLOVIR, DESGEWENST IN DE VORM VAN EEN FARMACEUTISCH AANVAARDBAAR ZOUT, IN HET BIJZONDER HET HYDROCHLORIDE; REGISTRATION NO/DATE: RVG 25992 20010920

CYTOVENE Market Analysis and Financial Projection Experimental

Cytomegalovirus Treatment Market Dynamics and Financial Trajectory for CYTOVENE

Market Overview

The cytomegalovirus (CMV) treatment market, in which CYTOVENE (ganciclovir) plays a significant role, is experiencing steady growth driven by several key factors. Here are the market dynamics and the financial trajectory for CYTOVENE.

Current Market Size and Growth Rate

As of 2022, the global cytomegalovirus treatment market was valued at USD 228.8 million. It is projected to grow at a Compound Annual Growth Rate (CAGR) of 6.1% from 2022 to 2028, reaching a market valuation of USD 326 million by the end of 2028[1].

Key Drivers of Market Growth

Increasing Incidence of CMV Infections

The rising incidence of CMV infections, particularly among immunocompromised populations such as organ transplant recipients and individuals with HIV/AIDS, is a major driver of the market. Improved diagnostics have enhanced detection rates, leading to an increased demand for effective antiviral treatments like CYTOVENE[1][3].

Rising Transplantation Activities

The surge in organ and stem cell transplants has increased the incidence of CMV infections among recipients, fueling the demand for advanced and targeted CMV treatments. Antiviral drugs like ganciclovir and valganciclovir are crucial in managing these infections[3].

Government Initiatives and Health Awareness

Government initiatives and rising health awareness are also driving the market. Increased financial allocations to healthcare, especially for infectious diseases like CMV, have expanded budgets and fostered innovation in CMV treatment options[3][4].

Role of CYTOVENE in the Market

Indications and Usage

CYTOVENE-IV (ganciclovir sodium) is indicated for the treatment of CMV retinitis in immunocompromised adult patients, including those with acquired immunodeficiency syndrome (AIDS). It is also used in the treatment of CMV infections in transplant recipients[2].

Market Demand

The demand for CYTOVENE is expected to rise due to its efficacy in treating CMV infections. Antiviral agents like ganciclovir and valganciclovir are gaining prominence, and CYTOVENE is a key player in this segment[1][3].

Challenges and Restraints

Side Effects and Risks

Despite its effectiveness, CYTOVENE is associated with several side effects and risks, including neutropenia, anemia, thrombocytopenia, and potential fetal toxicity. These adverse reactions can restrain market potential to some extent[2].

High Treatment Costs

The high costs associated with antiviral medications, diagnostics, and supportive care create a financial burden, restricting access to effective CMV treatments. This economic challenge affects vulnerable populations and healthcare systems with budget constraints[3].

Regional Market Performance

North America

North America is expected to hold a major market share in the global cytomegalovirus treatment market. The presence of major CMV treatment providers and rapid advancements in CMV diagnosis and treatment in this region are key factors driving market growth[1].

Europe

In Europe, the rising prevalence of congenital CMV infections, the increasing use of combinational antiviral therapies, and growing awareness of CMV treatment in stem cell transplants are significant trends expected to drive market growth[1].

Competitive Landscape

The global cytomegalovirus treatment market includes key players such as Chimerix Inc., Thermo Fisher Scientific, Abbott, Becton Dickinson and Company, Pfizer Inc., Merck & Company Inc., Mylan N.V., Johnson & Johnson, and Bio-Rad Laboratories Inc. These companies are profiled in various market surveys and are actively involved in research and development to meet the increasing demand for CMV treatments[1].

Distribution Channels

Hospital pharmacies currently account for a dominant share of 47.8% in the global cytomegalovirus treatment industry, indicating that these institutions are primary distribution channels for CYTOVENE and other CMV treatments[1].

Financial Projections

The global cytomegalovirus treatment market, driven by the demand for CYTOVENE and other antiviral agents, is projected to grow significantly. Here are some key financial projections:

• 2022 Market Size: USD 228.8 million[1]
• 2028 Market Size: USD 326 million[1]
• CAGR (2022-2028): 6.1%[1]

By 2032, the broader cytomegalovirus treatment market is estimated to reach USD 1,035.16 million, growing at a CAGR of 6.5% from 2024 to 2032[3].

Key Takeaways

• The cytomegalovirus treatment market is driven by increasing CMV infections, rising transplantation activities, and government initiatives.
• CYTOVENE is a critical antiviral agent in this market, indicated for treating CMV retinitis and other CMV infections.
• Despite its efficacy, CYTOVENE faces challenges such as side effects and high treatment costs.
• North America and Europe are key regions driving market growth.
• The market is expected to grow at a CAGR of 6.1% from 2022 to 2028, reaching USD 326 million by 2028.

FAQs

What is the current market size of the global cytomegalovirus treatment market?

The global cytomegalovirus treatment market was valued at USD 228.8 million in 2022[1].

What is the projected growth rate of the cytomegalovirus treatment market from 2022 to 2028?

The market is projected to grow at a CAGR of 6.1% from 2022 to 2028[1].

What are the primary drivers of the cytomegalovirus treatment market?

The primary drivers include the increasing incidence of CMV infections, rising transplantation activities, and government initiatives and health awareness[1][3].

What are the common side effects associated with CYTOVENE?

Common side effects include neutropenia, anemia, thrombocytopenia, pyrexia, diarrhea, and nausea[2].

Which regions are expected to lead the market growth for cytomegalovirus treatments?

North America and Europe are expected to lead the market growth due to the presence of major treatment providers and advancements in CMV diagnosis and treatment[1].