VALTREX Drug Patent Profile

When do Valtrex patents expire, and what generic alternatives are available?

Valtrex is a drug marketed by Glaxosmithkline and is included in one NDA.

The generic ingredient in VALTREX is valacyclovir hydrochloride. There are twenty-three drug master file entries for this compound. Thirty-eight suppliers are listed for this compound. Additional details are available on the valacyclovir hydrochloride profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Valtrex

A generic version of VALTREX was approved as valacyclovir hydrochloride by SUN PHARM INDS LTD on January 31^st, 2007.

Summary for VALTREX

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	54
Patent Applications:	1,470
Drug Prices:	Drug price information for VALTREX
What excipients (inactive ingredients) are in VALTREX?	VALTREX excipients list
DailyMed Link:	VALTREX at DailyMed

See drug prices for VALTREX

See drug sales revenues for VALTREX

Recent Clinical Trials for VALTREX

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

Sponsor	Phase
University of California, San Francisco	Early Phase 1
Vanderbilt University Medical Center	Phase 4
Columbia University	Phase 4

See all VALTREX clinical trials

Pharmacology for VALTREX

Drug Class	Herpes Simplex Virus Nucleoside Analog DNA Polymerase Inhibitor Herpes Zoster Virus Nucleoside Analog DNA Polymerase Inhibitor Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
Mechanism of Action	DNA Polymerase Inhibitors

US Patents and Regulatory Information for VALTREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-001	Jun 23, 1995	AB	RX	Yes	No
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-002	Jun 23, 1995	AB	RX	Yes	Yes

Expired US Patents for VALTREX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-002	Jun 23, 1995	4,567,182
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-001	Jun 23, 1995	6,107,302*PED
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-001	Jun 23, 1995	4,957,924*PED
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-002	Jun 23, 1995	6,107,302*PED
Glaxosmithkline	VALTREX	valacyclovir hydrochloride	TABLET;ORAL	020487-002	Jun 23, 1995	4,957,924*PED

International Patents for VALTREX

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

Country	Patent Number	Title	Estimated Expiration
Australia	612393
Bulgaria	63393
Canada	1340083	ESTERS DE 9-(2-HYDROXYETHOXYMETHYL)GUANINE POSSEDANT DES PROPRIETES ANTIVIRALES (ESTERS OF 9-(2-HYDROXYETHOXYMETHYL)GUANINE HAVING ANTIVIRAL PROPERTIES)
European Patent Office	0077460	PURINE COMPOUNDS ENDOWED WITH IMMUNOMODULATING ACTIVITY
United Kingdom	2208619	A SHEET METAL DRAWING TOOL AND METHODS OF MAKING AND USING SAME.

Supplementary Protection Certificates for VALTREX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0308065	97C0015	Belgium		PRODUCT NAME: VALACICLOVIR HYDROCHLORID; NAT. REGISTRATION NO/DATE: 725 IS 144 F 3 19970219; FIRST REGISTRATION: IE PA 17/111/1 19941220
0077460	97C0035	Belgium		PRODUCT NAME: VALACICLOVIR; NAT REG. NO/DATE: 725 IS 144 F 3; FIRST REG.: IE PA 17/111/1 19941212
0077460	SPC/GB95/020	United Kingdom		SPC/GB95/020:, EXPIRES: 20070907

Valtrex (Valacyclovir): Market Dynamics and Financial Trajectory

Introduction to Valacyclovir (Valtrex)

Valacyclovir, marketed under the brand name Valtrex, is an antiviral medication used to treat herpes simplex virus (HSV) infections, including genital herpes and cold sores, as well as varicella zoster virus (VZV) infections, which cause chickenpox and shingles.

Market Size and Growth

The global market for valacyclovir is part of the broader antiviral drugs market, particularly the herpes simplex virus treatment market. Here are some key statistics:

• Market Value: The global herpes simplex virus treatment market, which includes valacyclovir, was valued at approximately $1.724 billion in 2021 and is projected to reach $2.126 billion by 2031, growing at a CAGR of 2.1% from 2022 to 2031[3].
• Segment Dominance: Valacyclovir dominated the herpes simplex virus treatment market in 2021 due to its better safety profile and increased awareness about HSV infections, leading to higher demand for early treatment[3].

Drivers of Market Growth

Several factors are driving the growth of the valacyclovir market:

Increasing Prevalence of HSV Infections

The rising incidence of herpes simplex virus infections, including genital herpes and cold sores, is a significant driver. This increase is attributed to various factors, including higher transmission rates and growing awareness about the disease[4].

Growing Awareness and Destigmatization

As awareness about HSV infections grows, so does the willingness of individuals to seek treatment. This destigmatization has led to an increase in the number of people seeking medical help, thereby driving the market[4].

Proven Efficacy

Valacyclovir's proven efficacy in reducing the frequency and severity of HSV outbreaks has made it a preferred treatment option. This efficacy contributes to its market growth and acceptance among healthcare providers and patients[4].

Generic Competition and Affordability

The expiration of the patent for valacyclovir has led to the availability of generic versions, which has increased price competition and made the drug more affordable. This has expanded the market by making the drug accessible to a broader population[4].

Telemedicine and Online Platforms

The integration of telemedicine and online pharmaceutical platforms has facilitated easier access to valacyclovir prescriptions. This trend in digital health solutions has further boosted the market by providing convenient and time-saving options for patients[4].

Financial Trajectory

Revenue Forecast

The valacyclovir market is expected to continue its growth trajectory, driven by the factors mentioned above. Here are some financial highlights:

• Current Market Value: The herpes simplex virus treatment market, which includes valacyclovir, was valued at $1.724 billion in 2021[3].
• Projected Market Value: This market is expected to reach $2.126 billion by 2031, with a CAGR of 2.1% from 2022 to 2031[3].

Key Players and Market Share

Several pharmaceutical companies are key players in the valacyclovir market:

• GlaxoSmithKline plc: As the original developer and marketer of Valtrex, GSK holds a significant market share.
• Other Players: Companies like Pfizer Inc., Novartis AG, Abbott Laboratories, and generic manufacturers such as Teva Pharmaceutical Industries Ltd. and Viatris Inc. also play crucial roles in the market[3].

Distribution Channels

The distribution of valacyclovir is segmented into several channels:

Hospital Pharmacies

Hospital pharmacies are a significant distribution channel, especially for severe cases of HSV infections that require hospitalization.

Drug Stores & Retail Pharmacies

These outlets hold the largest market share due to their wide availability and variety of medications, including antiviral drugs like valacyclovir[3].

Online Providers

The online providers segment is expected to register the highest CAGR during the forecast period due to the convenience, time-saving, and increased awareness of online platforms[3].

Regional Market Dynamics

North America

North America is the largest regional market for herpes simplex virus treatment, including valacyclovir, due to the high incidence of HSV infections, presence of key players, and early diagnosis of the disease[3].

Asia-Pacific

The Asia-Pacific region is expected to witness significant growth due to the presence of pharmaceutical companies, growth in purchasing power, and the large medicine supply in countries like China and India[3].

Challenges and Opportunities

Social Stigma

Despite the growing awareness, social stigma associated with sexually transmitted diseases like HSV can hinder market growth. However, efforts to destigmatize these infections are ongoing and expected to mitigate this challenge[3].

Product Approvals and Regulatory Environment

Rise in the number of product approvals for HSV treatments drives market growth. Regulatory approvals and new drug launches are crucial for maintaining market momentum[3].

Competitive Landscape

The market is competitive, with several key players focusing on regulatory approvals, new drug launches, and strategic collaborations. Acquisitions and mergers also play a vital role in the growth of the market[1][3].

Key Takeaways

• Market Growth: The valacyclovir market is expected to grow at a CAGR of 2.1% from 2022 to 2031.
• Drivers: Increasing prevalence of HSV infections, growing awareness, proven efficacy, generic competition, and telemedicine are key drivers.
• Distribution: Drug stores & retail pharmacies currently dominate, but online providers are expected to grow significantly.
• Regional Dynamics: North America is the largest market, while Asia-Pacific is expected to grow rapidly.
• Challenges: Social stigma and product recalls are challenges, but regulatory approvals and new drug launches offer opportunities.

FAQs

Q: What is the current market size of the herpes simplex virus treatment market, which includes valacyclovir? A: The global herpes simplex virus treatment market was valued at approximately $1.724 billion in 2021[3].

Q: What is the projected growth rate of the valacyclovir market from 2022 to 2031? A: The market is expected to grow at a CAGR of 2.1% from 2022 to 2031[3].

Q: Which segment dominates the herpes simplex virus treatment market? A: The valacyclovir segment dominated the market in 2021 due to its better safety profile and increased awareness about HSV infections[3].

Q: What are the main distribution channels for valacyclovir? A: The main distribution channels include hospital pharmacies, drug stores & retail pharmacies, and online providers, with the latter expected to grow significantly[3].

Q: Which region is expected to witness the highest growth in the valacyclovir market? A: Asia-Pacific is expected to witness the highest growth rate during the forecast period due to various favorable factors such as the presence of pharmaceutical companies and growth in purchasing power[3].

Sources

1. Future Market Insights: Varicella Zoster Infection Treatment Market Trends & Share[1].
2. Vision Research Reports: Herpes Simplex Virus Treatment Market Size, Share[2].
3. Allied Market Research: Herpes Simplex Virus Treatment Market Statistics and Forecast - 2031[3].
4. IMARC Group: Valacyclovir (Valtrex) Manufacturing Plant Project Report 2024[4].
5. Valuates Reports: Global Valacyclovir Hydrochloride Market Research Report 2024[5].