VALGANCICLOVIR HYDROCHLORIDE - Generic Drug Details

What are the generic sources for valganciclovir hydrochloride and what is the scope of patent protection?

Valganciclovir hydrochloride is the generic ingredient in two branded drugs marketed by Cheplapharm, Actavis Labs Fl Inc, Ajanta Pharma Ltd, Appco, Aurobindo Pharma, Granules, Hetero Labs Ltd V, MSN, Aurobindo Pharma Ltd, Cipla, Dr Reddys, Pharmobedient, Somerset Theraps Llc, Sph Zhongxi Pharm, and Strides Pharma Intl, and is included in nineteen NDAs. There are two patents protecting this compound and two Paragraph IV challenges. Additional information is available in the individual branded drug profile pages.

Valganciclovir hydrochloride has thirty-six patent family members in thirty-one countries.

There are seventeen drug master file entries for valganciclovir hydrochloride. Nineteen suppliers are listed for this compound.

Summary for VALGANCICLOVIR HYDROCHLORIDE

International Patents:	36
US Patents:	2
Tradenames:	2
Applicants:	15
NDAs:	19
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	19
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	121
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VALGANCICLOVIR HYDROCHLORIDE
What excipients (inactive ingredients) are in VALGANCICLOVIR HYDROCHLORIDE?	VALGANCICLOVIR HYDROCHLORIDE excipients list
DailyMed Link:	VALGANCICLOVIR HYDROCHLORIDE at DailyMed

Recent Clinical Trials for VALGANCICLOVIR HYDROCHLORIDE

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

Sponsor	Phase
Columbia University	PHASE2
Cornell University	PHASE2
Sun Yat-sen University	PHASE2

See all VALGANCICLOVIR HYDROCHLORIDE clinical trials

Pharmacology for VALGANCICLOVIR HYDROCHLORIDE

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

Anatomical Therapeutic Chemical (ATC) Classes for VALGANCICLOVIR HYDROCHLORIDE

J05AB	Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

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

Paragraph IV (Patent) Challenges for VALGANCICLOVIR HYDROCHLORIDE

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VALCYTE	for Oral Solution	valganciclovir hydrochloride	50 mg/mL	022257	1	2011-03-21
VALCYTE	Tablets	valganciclovir hydrochloride	450 mg	021304	1	2005-12-27

US Patents and Regulatory Information for VALGANCICLOVIR HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Aurobindo Pharma	VALGANCICLOVIR HYDROCHLORIDE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	215124-001	Nov 17, 2022	AB	RX	No	No
Cheplapharm	VALCYTE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	022257-001	Aug 28, 2009	AB	RX	Yes	Yes	8,889,109		Y
Msn	VALGANCICLOVIR HYDROCHLORIDE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	210169-001	Feb 17, 2022	AB	RX	No	No
Actavis Labs Fl Inc	VALGANCICLOVIR HYDROCHLORIDE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	205220-001	Jul 18, 2016	AB	RX	No	No
Cipla	VALGANCICLOVIR HYDROCHLORIDE	valganciclovir hydrochloride	TABLET;ORAL	209672-001	Nov 9, 2018		DISCN	No	No

Expired US Patents for VALGANCICLOVIR HYDROCHLORIDE

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cheplapharm	VALCYTE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	022257-001	Aug 28, 2009	6,083,953*PED
Cheplapharm	VALCYTE	valganciclovir hydrochloride	TABLET;ORAL	021304-001	Mar 29, 2001	6,083,953*PED

International Patents for VALGANCICLOVIR HYDROCHLORIDE

Country	Patent Number	Title	Estimated Expiration
South Korea	101116553
Serbia	52457	PRAŠKASTA FORMULACIJA ZA VALGANCIKLOVIR (POWDER FORMULATION FOR VALGANCICLOVIR)
Colombia	6220902	FORMULACION EN POLVO DEL VALGANCICLOVIR
Serbia	52457
Australia	2007332640

Supplementary Protection Certificates for VALGANCICLOVIR HYDROCHLORIDE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	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	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	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 Valganciclovir Hydrochloride

Last updated: July 27, 2025

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Introduction

Valganciclovir hydrochloride, a prodrug of ganciclovir, is a vital antiviral medication primarily used for the prevention and treatment of cytomegalovirus (CMV) infections. Its significance stems from its efficacy in immunocompromised populations, notably post-transplant patients and individuals with AIDS. As the global healthcare landscape evolves, understanding the market dynamics and financial trajectory of valganciclovir hydrochloride provides critical insights for pharmaceutical stakeholders, investors, and healthcare policymakers.

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Market Overview

The pharmaceutical market for antiviral therapies has experienced sustained growth, driven primarily by the increasing prevalence of CMV infections, expanding transplant populations, and the rising HIV/AIDS burden. Valganciclovir hydrochloride, marketed under brands like Cytovene IV (by Roche/Novartis) and generics, remains a central component in CMV management, especially in developed economies.

Global Market Size and Growth

The global antiviral drugs market was valued at approximately USD 35 billion in 2022, with projections reaching USD 45 billion by 2027, compounded annually at around 4-6% (source: Global Data). Valganciclovir commentary is embedded within this context, constituting a significant segment due to its specific indication for CMV.

While exact sales figures for valganciclovir hydrochloride are proprietary and vary across regions, estimates suggest its global sales surpass USD 1 billion annually, with the United States commanding the largest share due to advanced healthcare infrastructure and higher transplant volumes.

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Key Market Drivers

Growing Incidence of CMV and Transplantation

CMV’s prevalence among immunocompromised patients sustains demand for potent antivirals. According to the CDC, approximately 50-80% of adults in the US are CMV-seropositive, which correlates with increased incidence in transplant recipients and HIV-positive populations.

Approximately 40,000 solid-organ transplants occur annually in the US, most requiring CMV prophylaxis, directly impacting valganciclovir sales. The expanding transplant pipeline globally, including emerging markets, further bolsters market demand.

Advancements in Transplantation and HIV Management

Innovations in transplant immunosuppression protocols and improved HIV therapies have elevated patient longevity, thus expanding the window for CMV prophylaxis. The integration of valganciclovir into treatment regimens underscores its importance.

Patent Expiry and Generic Competition

The original patent for valganciclovir expired in the late 2010s, paving the way for generic manufacturers to enter the market. Generics have led to price reductions, increasing accessibility while exerting downward pressure on revenue for branded products.

Regulatory Approvals and Expanding Indications

While valganciclovir is primarily indicated for CMV prophylaxis and treatment, research exploring broader antiviral applications could influence future sales. However, as of now, regulatory approval remains focused, maintaining a relatively niche market.

Emerging Market Penetration

Developing countries display rising CMV infection and transplantation rates, but market reach is constrained by cost considerations and healthcare infrastructure limitations. Nonetheless, increasing adoption of generic formulations indicates potential market growth.

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Market Challenges

Pricing and Reimbursement Constraints

In mature markets like the U.S. and Europe, reimbursement policies and cost-containment efforts influence product pricing. Governments and insurers favor generic options, marginalizing branded drugs' market share.

Side Effect Profile and Safety Concerns

Valganciclovir’s adverse effects, including neutropenia and potential teratogenicity, necessitate careful monitoring, which can limit its utilization. The development of safer alternatives or improved formulations may threaten market share.

Competition from Emerging Antivirals

Next-generation antivirals with enhanced efficacy and safety profiles, such as maribavir, are in clinical development or early approval, potentially displacing valganciclovir in some indications.

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Financial Trajectory

Revenue Trends

Following patent expiration, global sales of valganciclovir experienced a decline in branded revenue but stabilized through generic proliferation. In 2022, global revenues exceeded USD 1 billion, with growth expected to normalize or decline marginally as competition intensifies.

Pricing Dynamics

Generic entry facilitated significant price erosion—up to 60-70%—prompting manufacturers to optimize production efficiencies. Despite lower prices, increased volume sales from emerging markets support overall revenue stability.

Future Outlook

Sales growth is projected to stabilize or modestly decline in developed markets due to generic competition and tighter reimbursement policies. Conversely, markets in Asia-Pacific and Latin America may witness incremental growth owing to increasing transplantation and HIV management.

Emerging developments include:

• Biosimilars and New Formulations: Though biosimilars are less relevant, new formulations that reduce side effects or improve convenience can drive future revenues.
• Market Expansion: Increased healthcare infrastructure in emerging economies can expand the patient base, supporting long-term financial stability.

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Strategic Considerations for Stakeholders

Pharmaceutical companies should consider investments in differentiation strategies such as developing formulations with improved safety profiles or combination therapies. Investors need to monitor patent cliffs and the emergence of competitors carefully. Healthcare policymakers can influence drug access through reimbursement policies that shape market dynamics.

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Conclusion

Valganciclovir hydrochloride exhibits a mature, globally significant market, driven by the rising burden of CMV infections and transplantation needs. While patent expirations and generic competition pose revenue challenges, expanding indications and geographic markets offer growth opportunities. Long-term financial trends favor companies that innovate or capitalize on emerging markets with increasing demand.

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Key Takeaways

• The valganciclovir market is mature, with global sales exceeding USD 1 billion annually, predominantly in North America and Europe.
• Patent expirations have introduced significant generic competition, reducing prices and profit margins but expanding access.
• Growth drivers include increasing global transplantation procedures, HIV management improvements, and emerging markets.
• Challenges encompass pricing pressures, safety concerns, and competition from next-generation antivirals.
• Future growth depends on market expansion into emerging economies and innovative formulations addressing safety and compliance issues.

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FAQs

1. How has patent expiration affected valganciclovir hydrochloride’s market revenue?
Patent expirations led to the entry of generics, substantially reducing prices and revenues for branded products. However, overall market volume has maintained demand, supported by increased access in emerging markets.

2. What factors influence the adoption of valganciclovir in emerging markets?
Cost considerations, healthcare infrastructure, local prevalence of CMV infections, and regulatory approval significantly impact adoption rates in emerging countries.

3. Are there any promising alternatives to valganciclovir for CMV management?
Yes, drugs like maribavir and letermovir are in various stages of development or approval, offering potential alternatives with differing safety and efficacy profiles.

4. How do safety concerns impact valganciclovir’s market share?
Adverse effects such as neutropenia can limit usage frequency and dosage, prompting healthcare providers to weigh benefits against risks, especially in vulnerable populations.

5. What strategies can pharmaceutical companies employ to sustain revenues?
Focusing on developing safer formulations, expanding indications, penetrating untapped markets, and introducing combination therapies can help sustain or grow revenues amid generic competition.

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References

1. Global Data. (2022). Antiviral Drugs Market Analysis.
2. CDC. (2021). Cytomegalovirus (CMV) and Transplant Recipients.
3. MarketWatch. (2023). Valganciclovir Hydrochloride Market Trends.
4. ClinicalTrials.gov. (2023). Emerging Antiviral Therapies for CMV.
5. WHO. (2022). Global HIV/AIDS and Transplantation Statistics.