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
National Heart, Lung, and Blood Institute (NHLBI)	Phase 3
Fred Hutchinson Cancer Research Center	Phase 3
Rho Federal Systems Division, Inc.	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
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-002	Dec 12, 1997
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-001	Dec 22, 1994
Roche Palo	CYTOVENE	ganciclovir	CAPSULE;ORAL	020460-002	Dec 12, 1997
Cheplapharm	CYTOVENE	ganciclovir sodium	INJECTABLE;INJECTION	019661-001	Jun 23, 1989

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/000120The 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
Denmark	227782
Poland	242100
Spain	8507549
Spain	529384

Supplementary Protection Certificates for CYTOVENE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

Market Dynamics and Financial Trajectory for CYTOVENE (Ganciclovir)

Last updated: July 30, 2025

Introduction

CYTOVENE (Ganciclovir) remains a cornerstone in antiviral therapy, primarily targeting cytomegalovirus (CMV) infections in immunocompromised patient populations. Initially developed in the 1980s, Ganciclovir cemented its role amidst increasing demand for effective CMV management, especially in transplant recipients and HIV-infected individuals. This analysis explores the current market landscape, competitive forces, regulatory environment, and financial trajectories influencing CYTOVENE’s standing and future prospects.

Market Overview

Therapeutic Indications and Patient Demographics

CYTOVENE is indicated for prophylaxis and treatment of CMV infections, notably in:

• Hematopoietic stem cell transplant (HSCT) patients
• Solid organ transplant recipients
• HIV/AIDS patients with active CMV retinitis

The global immunosuppressed population continues to expand, with an aging demographic and increasing transplantation procedures. The U.S. alone reports approximately 20,000 transplant procedures annually, with a significant subset requiring CMV management (1). The prevalence of HIV/AIDS remains high globally, with over 37 million individuals affected, many requiring antiviral therapy for CMV retinitis (2).

Market Size and Growth

The global antiviral drugs market, valued at approximately USD 42 billion in 2022, is projected to grow at a CAGR of 7.2% through 2027, driven by increasing infectious disease burdens and expanding indications for existing antivirals (3). Within this, the segment for CMV antivirals is critical, with Ganciclovir occupying a significant share historically, complemented by newer agents like Valganciclovir and Letermovir.

Pricing and Reimbursement Trends

CYTOVENE’s pricing reflects its patent status, manufacturing costs, and therapeutic value. Despite its age, it retains premium pricing in many jurisdictions, especially in hospitals and specialized clinics. Reimbursement frameworks favor established therapies due to clinical familiarity, although cost pressures and biosimilar competition influence prices and access dynamics.

Competitive Landscape

Existing and Emerging Agents

• Valganciclovir: An oral prodrug with similar efficacy but improved convenience, now often preferred for prophylaxis.
• Letermovir: Markedly advances prophylactic options with a favorable safety profile, particularly in HSCT settings (approved in 2017).
• Foscarnet and Cidofovir: Reserved for resistant cases due to toxicity profiles, limiting widespread use.

The emergence of novel agents and formulations continuously shifts competitive advantages, threatening CYTOVENE’s market dominance in certain segments, especially for outpatient prophylaxis.

Patent Status and Generic Competition

Ganciclovir’s patent expiration in many regions has opened avenues for generic production, fostering price competition and market penetration. Manufacturers have introduced generic versions at significant discounts, intensifying pricing pressures on CYTOVENE.

Regulatory and Patent Considerations

Despite its age, CYTOVENE remains under patent protection in some territories through formulations or method-of-use patents, delaying generic entry. Regulatory approvals have persisted given its established efficacy and safety. However, incentives for developing new CMV therapies have increased, with regulatory pathways favoring expedited review processes and orphan designations.

Financial Trajectory and Future Outlook

Revenue Trends

Historical data shows CYTOVENE’s revenues peaked during the early 2000s, influenced by high demand in transplant settings. The subsequent introduction of oral formulations and newer agents has caused a gradual decline in sales in mature markets, though in emerging regions, growth persists driven by increased transplant rates and limited access to newer drugs (4).

Profitability and Cost Dynamics

Manufacturing costs for Ganciclovir are relatively stable, but pricing pressures and market share erosion constrain margins. Companies leveraging patents or unique formulations preserve profitability longer. Entry of generics further compresses prices, necessitating cost efficiencies in production and distribution.

Growth Opportunities

• Expanding Indications: Off-label uses and potential for long-acting formulations could sustain demand.
• Emerging Markets: Growing healthcare infrastructure and transplant programs can bolster sales.
• Combination Therapies: Synergies with other antivirals or immunomodulators present innovation avenues.

Threats and Challenges

• Therapy Resistance: Emergence of resistant CMV strains can limit Ganciclovir’s efficacy.
• Advancement of Newer Agents: Agents like Letermovir, with improved safety profiles, could diminish CYTOVENE’s clinical utility.
• Generic Competition: Price erosion may substantially impact revenue streams.

Strategic Implications

Pharmaceutical companies involved with CYTOVENE must adapt by diversifying or enhancing formulations, exploring new indications, or acquiring pipeline assets. Cost containment, strategic pricing, and engagement with regulatory agencies are vital to maintaining financial viability.

Key Takeaways

• Market Positioning: CYTOVENE remains a vital antiviral, especially within hospital settings, but faces stiff competition from newer agents and generics.
• Revenue Outlook: Revenue growth prospects are modest, with declining trends in mature markets compensated by emerging regions.
• Strategic Focus: Innovation in formulations, expanding indications, and navigating patent landscapes are essential for sustained profitability.
• Market Risks: Resistance development, regulatory shifts, and commoditization threaten long-term viability.
• Investment Perspective: Stakeholders should weigh CytoVene’s established efficacy against competitive pressures and explore opportunities within emerging markets and novel formulations.

Conclusion

CYTOVENE’s financial outlook is characterized by a mature product facing increasing generic competition and evolving therapeutic landscapes. While its essential role in CMV management secures steady demand, future growth hinges on strategic adaptation—embracing innovation, expanding indications, and accessing emerging markets. Market participants must remain vigilant to shifts in regulatory policies and technological advances that could redefine competitive standings in this vital antiviral space.

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FAQs

1. How does CYTOVENE compare to newer CMV antivirals like Letermovir?
Letermovir offers a superior safety profile and ease of administration, particularly for prophylaxis in transplant patients, potentially reducing CYTOVENE’s niche. However, CYTOVENE remains critical in treatment-resistant or refractory cases.

2. What factors are influencing the price of CYTOVENE?
Pricing is affected by patent status, manufacturing costs, generic competition, and reimbursement policies. Patent expirations are leading to increased generic availability, exerting downward pressure on prices.

3. Are there ongoing efforts to develop alternative CMV therapies?
Yes, research is active in developing novel antivirals, vaccines, and immune-based therapies, which may further impact CYTOVENE’s market share.

4. How significant are emerging markets for the future of CYTOVENE?
Emerging markets present growth opportunities due to expanding healthcare infrastructure, increasing transplant activities, and limited access to newer therapies.

5. What strategies can companies adopt to sustain CYTOVENE’s revenue?
Strategies include developing new formulations, exploring additional indications, negotiating favorable reimbursement terms, and securing patents through innovative delivery methods.

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References

[1] AABB. (2022). Transplant statistics and trends.
[2] UNAIDS. (2022). Global AIDS update.
[3] Market Data Reports. (2022). Global antiviral drugs market analysis.
[4] PharmaMed Tech Report. (2022). Ganciclovir market dynamics.