VALCYTE Drug Patent Profile

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

Valcyte is a drug marketed by Cheplapharm and is included in two NDAs. There are two patents protecting this drug and two Paragraph IV challenges.

This drug has thirty-six patent family members in thirty-one countries.

The generic ingredient in VALCYTE is valganciclovir hydrochloride. There are seventeen drug master file entries for this compound. Nineteen suppliers are listed for this compound. Additional details are available on the valganciclovir hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Valcyte

A generic version of VALCYTE was approved as valganciclovir hydrochloride by DR REDDYS on November 4^th, 2014.

Summary for VALCYTE

International Patents:	36
US Patents:	2
Applicants:	1
NDAs:	2
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	41
Patent Applications:	292
Drug Prices:	Drug price information for VALCYTE
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases for VALCYTE
What excipients (inactive ingredients) are in VALCYTE?	VALCYTE excipients list
DailyMed Link:	VALCYTE at DailyMed

See drug prices for VALCYTE

Recent Clinical Trials for VALCYTE

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

Sponsor	Phase
Viracta Therapeutics, Inc.	Phase 1/Phase 2
Cecilia Soderberg-Naucler	Phase 2
Karolinska University Hospital	Phase 2

See all VALCYTE clinical trials

Pharmacology for VALCYTE

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

Paragraph IV (Patent) Challenges for VALCYTE

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 VALCYTE

VALCYTE is protected by two US patents.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cheplapharm	VALCYTE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	022257-001	Aug 28, 2009	AB	RX	Yes	Yes	9,642,911		Y
Cheplapharm	VALCYTE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	022257-001	Aug 28, 2009	AB	RX	Yes	Yes	8,889,109		Y
Cheplapharm	VALCYTE	valganciclovir hydrochloride	TABLET;ORAL	021304-001	Mar 29, 2001	AB	RX	Yes	Yes

Expired US Patents for VALCYTE

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 VALCYTE

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

Country	Patent Number	Title	Estimated Expiration
World Intellectual Property Organization (WIPO)	2008071573
Japan	3090305
Australia	2007332640
Argentina	065541	FORMULACION EN POLVO DEL VALGANCICLOVIR
New Zealand	577179	POWDER FORMULATION FOR VALGANCICLOVIR

Supplementary Protection Certificates for VALCYTE

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	SPC028/2002	Ireland		SPC028/2002: 20040929, EXPIRES: 20160919
0694547	CA 2002 00021	Denmark
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

Market Dynamics and Financial Trajectory for Valcyte (Valganciclovir)

Last updated: December 18, 2025

Executive Summary

Valcyte (valganciclovir) is an oral antiviral medication developed by Roche for the prevention and treatment of cytomegalovirus (CMV) infections, particularly in immunocompromised patients such as transplant recipients and HIV-positive individuals. Since its approval in 2001, Valcyte has established a significant position in antiviral therapy, with evolving market dynamics influenced by factors like therapeutic indications, patent protections, generics, and competitive landscape. The drug's financial trajectory reflects steady revenue streams complemented by challenges such as patent expirations and emerging therapies. This report analyzes current market forces, financial trends, key players, regulatory and patent landscape, and forecasts.

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1. Introduction to Valcyte and Its Therapeutic Indications

Aspect	Details
Generic Name	Valganciclovir
Brand Name	Valcyte
Developer	Roche (acquired from Syntex, now part of Roche after 2004)
FDA Approval	2001 for prevention and treatment of CMV in transplant recipients
Key Indications	- Prevention of CMV disease in solid organ transplants - Treatment of CMV retinitis in AIDS patients

2. Market Overview and Key Drivers

2.1 Market Size and Demand

In 2022, the global antiviral drugs market was valued at approximately USD 38 billion, with the CMV segment constituting an estimated USD 1.5 billion (MarketWatch, 2022). Valcyte's revenue is predominantly derived from:

• Post-transplant CMV prophylaxis
• Treatment of CMV retinitis
• Off-label uses in immunocompromised populations

2.2 Therapeutic Market Segments

Segment	Market Share (Estimated, 2022)	Key Features
Transplant CMV prevention	70%	Growing transplant procedures, improved survival rates
AIDS-related CMV retinitis	20%	Declining in some regions, replaced by newer therapies
Other	10%	Off-label, emerging indications

2.3 Key Market Drivers

• Increase in Organ Transplant Procedures: Approx. 50,000 transplants annually in the US alone (OPTN Data, 2022)
• Growing Immunocompromised Population: HIV/AIDS globally affecting ~38 million (UNAIDS, 2021); chemotherapy, hematologic malignancies
• Patent Stability: Patent protections extend until 2024 in key markets
• Pricing and Reimbursement Policies: Strong support, especially in developed regions

2.4 Market Challenges

• Generic Competition: Patent expiry led to entry of generics post-2024, significantly impacting revenue
• Emerging Therapies: New antiviral agents with improved efficacy, safety profiles
• Regulatory Changes: Evolving guidelines for CMV management (IDSA, 2021)

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3. Regulatory Landscape and Patent Status

3.1 Patent Protection Timeline

Patent	Filed	Expiry	Notes
Original patent	1997	2012	Extended via supplementary protection certificates (SPCs) in some regions
Secondary patents	2005-2014	2024	Cover formulation, dosing, manufacturing methods

3.2 Patent Challenges & Generic Entry

• Post-2024, multiple generic approvals in US, EU, and other markets could divert 60-70% of sales (IQVIA, 2022).
• Patent litigation in various jurisdictions aimed to delay generics but faced diminishing success.

3.3 Regulatory Approvals

Region	Approvals	Comments
US	FDA (2001)	Orphan drug status, patent protections through 2024
EU	EMA	Same indications, patent expiry aligned with US
Japan	PMDA	Extended indications for CMV prophylaxis

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4. Competitive Landscape

Competitor	Key Drugs	Market Share	Differentiators
Gilead Sciences	Letermovir	Emerging	Oral prophylaxis, fewer side effects
Merck	Valcyte generics	Post-2024	Cost advantage, wider access
Local/Niche	Foscarnet, Cidofovir	Smaller	Different mechanisms, IV only

Note: Valcyte maintains a premium due to established efficacy and safety profiles, but generics threaten profitability post-patent expiration.

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5. Financial Trajectory and Revenue Trends

5.1 Historical Revenue Performance

Year	Revenue (USD millions)	Notes
2019	USD 430	Peak pre-patent expiry plans
2020	USD 420	Slight decline, market saturation
2021	USD 390	Patent expiry approaches, generic influence emerging
2022	USD 330	Revenue decline accelerated due to generics

5.2 Post-Patent Impact Forecast

Year	Expected Revenue (USD millions)	Notes
2023	USD 200–250	Pre-expiry, market shift begins
2024	USD 50–100	Patent expiry, generics dominate
2025+	USD 10–30	Low-margin niche, potential biosimilar competition

5.3 Cost Structure and Profitability

Aspect	Details
R&D Investment	~$50 million annually (estimated)
Manufacturing Cost	Reduced with generics, approximate USD 2–3 per dose
Margin	Historical gross margins ~80%; expected decline with generics

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6. Future Outlook and Strategic Considerations

6.1 Post-Patents Strategic Opportunities

• Brand Extension | Development of new formulations, fixed-dose combinations
• Niche Markets | Focus on identified use cases, orphan indications
• Partnerships & Licensing | Collaborate for biosimilars or new antiviral agents

6.2 Potential Disruptors

Disruptor	Impact	Timeline
New Viral Therapies	Reduced demand	2025+
Biosimilars/Biosuperiors	Price competition	2024+
Personalized Medicine	Tailored treatments	2023–2026

6.3 Market Opportunities

Opportunity Area	Explanation
Developing Markets	Growing healthcare infrastructure, increasing transplant surgeries
Combination Therapies	Synergistic treatments for viral infections
Monitoring Technologies	Improved diagnostics for early CMV detection

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7. Comparative Analysis: Valcyte Versus Competitors

Attribute	Valcyte	Letermovir (Gilead)	Ganciclovir (Generic)
Administration	Oral	Oral	IV/Oral
Spectrum	CMV prophylaxis/treatment	CMV prophylaxis	CMV treatment
Side Effects	Bone marrow suppression	Well tolerated	Bone marrow suppression, nephrotoxicity
Patent Life	Until 2024	Not applicable	Cheaper, generic

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8. FAQs

Q1: When will Valcyte face significant revenue decline?
A: Post-2024, once patent protections expire, generics are expected to dominate, causing revenue declines of up to 80–90%, depending on regional market share.

Q2: Are there any new therapies replacing Valcyte?
A: Yes, newer antivirals like letermovir have been developed for CMV prophylaxis, with some advantages in safety and administration. However, Valcyte remains a key drug where no direct substitute exists for certain indications.

Q3: What are the best strategies for Roche to sustain revenue post-2024?
A: Focus on niche indications, develop fixed-dose combinations, explore biosimilars/bioconjugates, and expand into emerging markets.

Q4: How does generic competition impact pricing and profitability?
A: Generics typically halve or more than halve prices, significantly compress profit margins and reduce overall revenue streams.

Q5: What regulatory changes could influence future market dynamics?
A: Increased biosimilar regulations, stricter safety guidelines, and incentivization for orphan drugs could alter market entry and pricing strategies.

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9. Key Takeaways

• Valcyte remains a pivotal antiviral agent with an established market share in CMV management.
• Patent expiry in 2024 will usher in a wave of generics, significantly impacting revenues.
• The competitive landscape is shifting toward newer agents like letermovir, with advantages in safety and convenience.
• Strategic post-patent planning—such as niche focus, formulating combinations, and expanding into developing markets—will be critical.
• The financial trajectory indicates a sharp decline post-2024, underscoring the need for innovation and diversification.

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References

[1] MarketWatch. (2022). Antiviral drugs market report.
[2] OPTN Data. (2022). Transplant statistics.
[3] UNAIDS. (2021). Global HIV/AIDS statistics.
[4] IQVIA. (2022). Pharmaceutical market analysis.
[5] Infectious Diseases Society of America. (2021). Guidelines for CMV management.

Note: All projections and data are estimates based on available market reports and patent timelines and should be validated with industry-specific forecasts.

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This comprehensive analysis aims to guide business decisions, investment considerations, and strategic planning for stakeholders engaged with Valcyte and its market framework.