VALCYTE Drug Patent Profile

When do Valcyte patents expire, 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. Twenty-one 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:	2
Raw Ingredient (Bulk) Api Vendors:	82
Clinical Trials:	41
Patent Applications:	227
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	TABLET;ORAL	021304-001	Mar 29, 2001	AB	RX	Yes	Yes
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

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
Peru	20081578	FORMULACION EN POLVO DE VALGANCICLOVIR
Ukraine	93599	ПОРОШКОПОДІБНИЙ ПРЕПАРАТ ВАЛГАНЦИКЛОВІРУ[Порошкообразный препарат валганцикловира (powder valgancyclovir preparation)
World Intellectual Property Organization (WIPO)	2008071573

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

Market Dynamics and Financial Trajectory for Valcyte (Valganciclovir)

Introduction to Valcyte

Valcyte, or valganciclovir, is an antiviral medication primarily used to treat and prevent cytomegalovirus (CMV) infections, particularly in individuals with weakened immune systems such as those with HIV/AIDS or organ transplant recipients. Here, we delve into the market dynamics and financial trajectory of this crucial drug.

Market Size and Growth

The global valganciclovir market is experiencing significant growth. As of 2024, the market size 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 of 2024-2030[1].

Another forecast indicates that the market will grow at a CAGR of 4.6% from 2022 to 2031, reaching more than US$ 484.1 million by the end of 2031[4].

Key Drivers of Market Growth

Several factors are driving the growth of the valganciclovir market:

Increase in CMV Infections

The rise in the number of people with CMV retinitis, especially among HIV/AIDS patients, is a significant driver. CMV retinitis held more than 53.0% of the market share in 2021[4].

Organ Transplants

The increasing number of organ transplants globally is another key factor. According to the Global Observatory on Donation and Transplantation (GODT), more than 146,000 solid organ transplants are performed annually, with this number expected to rise in the coming years[4].

Government Support and Research Funding

Favorable government support in terms of reimbursement and research funding is also propelling the market. This support enables further research and development, including the exploration of new indications such as glioblastoma[4].

Market Segmentation

The valganciclovir market is segmented based on several criteria:

By Application

The primary applications include the treatment and prevention of CMV infections in adults and children, particularly those with HIV/AIDS and organ transplant recipients[1][2].

By Distribution Channel

Hospital pharmacies dominate the market, accounting for more than 80% of the share in 2021. Retail pharmacies also play a significant role, especially in regions like Asia Pacific and the Middle East[4].

By Region

North America holds a significant market share, driven by the rise in awareness and adoption of quick treatment options, as well as an increase in organ transplants. The U.S. Department of Health & Human Services reported 41,354 organ transplants in 2021, a 5.9% increase over 2020[4].

Key Players and Competitive Landscape

The valganciclovir market is characterized by the presence of several key players:

• F. Hoffmann-La Roche AG: Historically the primary manufacturer, though the worldwide rights to Valcyte were acquired by Cheplapharm Arzneimittel GmbH in 2022[5].
• Endo International plc
• Dr. Reddy's Laboratories
• Cipla Limited
• Alniche Life Sciences Pvt. Ltd
• Anthem Biosciences Private Limited
• Merck & Co., Inc.
• Panacea Biotec Ltd.
• Camber Pharmaceuticals, Inc.[4].

These companies are focusing on introducing generic versions of valganciclovir, especially in tablet form, to cater to the growing demand.

Financial Implications and Assistance Programs

The cost of valganciclovir can be prohibitive for many patients. To address this, various patient assistance programs are available:

• Simplefill: This program connects patients with prescription assistance sources, helping to alleviate the financial stress associated with the medication. Simplefill handles the application and enrollment process for these programs, ensuring uninterrupted access to valganciclovir[2].

Adverse Effects and Safety Considerations

Valganciclovir has several potential adverse effects, including diarrhea, pyrexia, nausea, tremor, neutropenia, anemia, graft rejection, and thrombocytopenia. It is also potentially mutagenic and carcinogenic based on animal studies. Special caution is advised in elderly patients and those with renal impairment[3].

Future Outlook

The valganciclovir market is poised for continued growth driven by increasing demand for antiviral treatments, especially in the context of rising organ transplants and CMV infections. The development of generic versions and ongoing research into new indications will further expand the market.

Strategic Collaborations

Companies are collaborating with academic research institutes to explore new applications of valganciclovir, such as its use in treating glioblastoma. These collaborations are expected to open up new market opportunities[4].

Key Takeaways

• The global valganciclovir market is projected to grow significantly, with a CAGR of 5.8% from 2024 to 2030 and reaching US$ 325.4 million by 2030.
• Key drivers include the rise in CMV infections, increasing organ transplants, and favorable government support.
• The market is dominated by hospital pharmacies, with North America holding a significant share.
• Major players are focusing on introducing generic versions and exploring new indications.
• Patient assistance programs are crucial in making the medication accessible to those in need.

FAQs

What is Valcyte used for?

Valcyte (valganciclovir) is used to treat and prevent cytomegalovirus (CMV) infections in individuals with weakened immune systems, such as those with HIV/AIDS or organ transplant recipients[2].

What is the projected market size of valganciclovir by 2030?

The global valganciclovir market is expected to reach US$ 325.4 million by 2030[1].

Who are the main players in the valganciclovir market?

Key players include F. Hoffmann-La Roche AG, Endo International plc, Dr. Reddy's Laboratories, Cipla Limited, and others[4].

What are the common adverse effects of valganciclovir?

Common adverse effects include diarrhea, pyrexia, nausea, tremor, neutropenia, anemia, graft rejection, and thrombocytopenia[3].

How can patients access financial assistance for valganciclovir?

Patients can access financial assistance through programs like Simplefill, which connects them with prescription assistance sources and handles the application and enrollment process[2].

What is the impact of organ transplants on the valganciclovir market?

The increasing number of organ transplants globally is a significant driver of the valganciclovir market, as these patients often require antiviral prophylaxis to prevent CMV infections[4].

Sources

1. Global Valganciclovir Market Insights, Forecast to 2030 - Valuates Reports
2. Valcyte Patient Assistance Programs - Simplefill
3. Valcyte (valganciclovir) - FDA
4. Valganciclovir Market Report Size, Growth | Forecast 2031 - Transparency Market Research
5. Valcyte® (valganciclovir hydrochloride) - Information for Patients - Genentech