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, Norvium Bioscience, Somerset Theraps Llc, and Strides Pharma, and is included in eighteen 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. Twenty-one suppliers are listed for this compound.

Summary for VALGANCICLOVIR HYDROCHLORIDE

International Patents:	36
US Patents:	2
Tradenames:	2
Applicants:	14
NDAs:	18
Drug Master File Entries:	17
Finished Product Suppliers / Packagers:	21
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	109
Patent Applications:	316
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
Merck Sharp & Dohme LLC	Phase 2
University of Pennsylvania	Phase 2
Takeda	Phase 4

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
Dr Reddys	VALGANCICLOVIR HYDROCHLORIDE	valganciclovir hydrochloride	TABLET;ORAL	206876-001	Dec 12, 2017	AB	RX	No	No
Dr Reddys	VALGANCICLOVIR HYDROCHLORIDE	valganciclovir hydrochloride	TABLET;ORAL	203511-001	Nov 4, 2014	AB	RX	No	No
Ajanta Pharma Ltd	VALGANCICLOVIR HYDROCHLORIDE	valganciclovir hydrochloride	FOR SOLUTION;ORAL	212890-001	Jan 13, 2020	AB	RX	No	No
Cipla	VALGANCICLOVIR HYDROCHLORIDE	valganciclovir hydrochloride	TABLET;ORAL	209672-001	Nov 9, 2018		DISCN	No	No
Somerset Theraps Llc	VALGANCICLOVIR HYDROCHLORIDE	valganciclovir hydrochloride	TABLET;ORAL	212876-001	Jun 11, 2024	AB	RX	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
Denmark	2101733
Cyprus	1113468
Brazil	PI0720118	FORMULAÇÃO EM PÓ PARA VALGANCICLOVIR
Japan	2010513237
Costa Rica	10822	FORMULACION EN POLVO DEL VALGANCICLOVIR

Supplementary Protection Certificates for VALGANCICLOVIR HYDROCHLORIDE

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

VALGANCICLOVIR HYDROCHLORIDE Market Analysis and Financial Projection Experimental

Valganciclovir Hydrochloride Market Dynamics and Financial Trajectory

Market Introduction

Valganciclovir hydrochloride, marketed under the brand name Valcyte, is an antiviral medication used to treat cytomegalovirus (CMV) infections, particularly in patients with HIV/AIDS or those who have undergone organ transplants. The drug is a prodrug of ganciclovir and is administered orally.

Market Size and Growth

The valganciclovir market is poised for significant growth over the coming years. As of 2024, the global valganciclovir market was valued at US$ 232 million and is projected to reach US$ 325.4 million by 2030, growing at a Compound Annual Growth Rate (CAGR) of 5.8% during the forecast period[1].

Drivers of Market Growth

Several factors are driving the growth of the valganciclovir market:

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. Improved diagnostics have enhanced detection rates, leading to an increased demand for effective antiviral treatments like valganciclovir[3].

Advanced Technology and Geriatric Population

Advancements in technology and an increase in the geriatric population are also contributing to market growth. New products with improved shelf life and extended expiry dates are expected to benefit the market in the forecast period[4].

Rising Transplantation Activities

The surge in organ and stem cell transplantation activities has increased the incidence of CMV infections among recipients, fueling the demand for valganciclovir and other CMV treatments[3].

Global Healthcare Expenditure

Increased financial allocations to healthcare, especially for infectious diseases like CMV, are driving the market. The growing emphasis on advanced antiviral therapies and enhanced awareness and diagnostics further contribute to the market's expansion[3].

Market Segmentation

The valganciclovir market is segmented based on type and application:

By Type

• Powder for solution
• Tablets[4]

By Application

• Adults
• Children[4]

Regional Framework

The market is analyzed across several regions, including North America, Europe, Asia-Pacific, Middle East and Africa, and South and Central America. Each region is further sub-segmented by country to provide a detailed overview of the market dynamics[4].

Key Players

The valganciclovir market is dominated by several key players, including:

• F Hoffmann La Roche Ltd
• Genentech Inc
• Cipla Inc
• Alniche Life Sciences Pvt Ltd
• Anthem Bio Sciences
• Aspire Group
• Jolly Pharmaceuticals
• Panacea Biotec Ltd
• Rakshit Drugs Pvt Ltd[4]

Financial Trajectory

The financial trajectory of the valganciclovir market is characterized by steady growth driven by increasing demand and advancements in healthcare.

Revenue Forecast

The market is expected to grow from US$ 232 million in 2024 to US$ 325.4 million by 2030, with a CAGR of 5.8% during the forecast period. This growth is supported by rising healthcare expenditures and the increasing incidence of CMV infections[1].

Operating and Nonoperating Revenues

While the specific financial statements for the valganciclovir market are not detailed, the overall pharmaceutical industry trends indicate that operating revenues are driven by sales of the drug, while nonoperating revenues may include investments, grants, and other financial activities. The market's growth is also influenced by nonoperating factors such as regulatory approvals and international collaborations[3].

Challenges

Despite the positive growth trajectory, the valganciclovir market faces several challenges:

High Cost of Treatment

The high cost of valganciclovir treatment is a significant barrier to market growth. This can limit access to the drug, especially in regions with limited healthcare resources[3].

Side Effects and Safety Concerns

Valganciclovir is associated with several side effects, including abdominal pain, headaches, trouble sleeping, nausea, fever, and low blood cell counts. These side effects can impact patient compliance and overall market demand[4].

Conclusion

The valganciclovir market is poised for significant growth driven by the increasing incidence of CMV infections, advancements in technology, and rising healthcare expenditures. However, the market must navigate challenges such as the high cost of treatment and safety concerns to fully realize its potential.

Key Takeaways

• The global valganciclovir market is expected to grow from US$ 232 million in 2024 to US$ 325.4 million by 2030.
• The market is driven by the increasing incidence of CMV infections, advancements in technology, and rising healthcare expenditures.
• Key players include F Hoffmann La Roche Ltd, Genentech Inc, and Cipla Inc.
• The market faces challenges such as high treatment costs and safety concerns.

FAQs

Q: What is the primary use of valganciclovir hydrochloride? A: Valganciclovir hydrochloride is used to treat cytomegalovirus (CMV) infections, particularly in patients with HIV/AIDS or those who have undergone organ transplants.

Q: What is the projected CAGR of the valganciclovir market from 2024 to 2030? A: The valganciclovir market is expected to grow at a CAGR of 5.8% from 2024 to 2030.

Q: Which regions are covered in the valganciclovir market analysis? A: The market analysis covers North America, Europe, Asia-Pacific, Middle East and Africa, and South and Central America.

Q: What are the main side effects associated with valganciclovir? A: Common side effects include abdominal pain, headaches, trouble sleeping, nausea, fever, and low blood cell counts.

Q: Who are the key players in the valganciclovir market? A: Key players include F Hoffmann La Roche Ltd, Genentech Inc, Cipla Inc, Alniche Life Sciences Pvt Ltd, and others.

Sources

1. Global Valganciclovir Market Insights, Forecast to 2030 - Valuates Reports
2. Northwestern University Single Audit Report - Northwestern University
3. Cytomegalovirus Treatment Market Size, Share, Global Analysis - Polaris Market Research
4. Valganciclovir Market SWOT Analysis by 2031 - The Insight Partners
5. VALCYTE (valganciclovir hydrochloride tablets) Label - FDA