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Last Updated: March 17, 2025

Valacyclovir hydrochloride - Generic Drug Details


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What are the generic drug sources for valacyclovir hydrochloride and what is the scope of freedom to operate?

Valacyclovir hydrochloride is the generic ingredient in two branded drugs marketed by Apotex, Aurobindo Pharma, Chartwell Rx, Cipla, Graviti Pharms, Hetero Labs Ltd V, Hikma, Jubilant Generics, Mylan Pharms Inc, Norvium Bioscience, Sandoz, Sun Pharm Inds Ltd, Teva Pharms, Watson Labs Inc, Yiling, Zydus Lifesciences, and Glaxosmithkline, and is included in seventeen NDAs. Additional information is available in the individual branded drug profile pages.

There are twenty-two drug master file entries for valacyclovir hydrochloride. Thirty-eight suppliers are listed for this compound.

Summary for valacyclovir hydrochloride
US Patents:0
Tradenames:2
Applicants:17
NDAs:17
Drug Master File Entries: 22
Finished Product Suppliers / Packagers: 38
Raw Ingredient (Bulk) Api Vendors: 90
Clinical Trials: 120
Patent Applications: 2,274
What excipients (inactive ingredients) are in valacyclovir hydrochloride?valacyclovir hydrochloride excipients list
DailyMed Link:valacyclovir hydrochloride at DailyMed
Recent Clinical Trials for valacyclovir hydrochloride

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

SponsorPhase
Loxo Oncology, Inc.Phase 2
The Leukemia and Lymphoma SocietyPhase 2
University of California, San FranciscoEarly Phase 1

See all valacyclovir hydrochloride clinical trials

US Patents and Regulatory Information for valacyclovir hydrochloride

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Sun Pharm Inds Ltd VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 076588-002 Jan 31, 2007 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Teva Pharms VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 077655-001 May 24, 2010 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hikma VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 078656-002 May 24, 2010 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Chartwell Rx VALACYCLOVIR HYDROCHLORIDE valacyclovir hydrochloride TABLET;ORAL 090216-001 May 24, 2010 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>TE>Type>RLD>RS>Patent No.>Patent Expiration>Product>Substance>Delist Req.>Exclusivity Expiration
Showing 1 to 4 of 4 entries

Expired US Patents for valacyclovir hydrochloride

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-001 Jun 23, 1995 6,107,302*PED ⤷  Try for Free
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-002 Jun 23, 1995 4,567,182 ⤷  Try for Free
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-001 Jun 23, 1995 4,567,182 ⤷  Try for Free
Glaxosmithkline VALTREX valacyclovir hydrochloride TABLET;ORAL 020487-001 Jun 23, 1995 4,957,924*PED ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries

Market Dynamics and Financial Trajectory for Valacyclovir Hydrochloride

Introduction

Valacyclovir hydrochloride, commonly known by its brand name Valtrex, is a widely used antiviral medication for treating herpes simplex virus (HSV) infections, including genital herpes, cold sores, shingles, and chickenpox. This article delves into the market dynamics and financial trajectory of valacyclovir hydrochloride, highlighting key factors influencing its growth, market segmentation, competitive landscape, and financial projections.

Market Size and Growth

The global valacyclovir hydrochloride market has been experiencing significant growth, driven by several key factors. As of 2023, the market size was valued at several million USD, with a projected compound annual growth rate (CAGR) that will drive the market to reach substantial figures by 2031[1][4].

Drivers of Market Growth

Increasing Prevalence of HSV Infections

The rising prevalence of HSV infections, including genital herpes and cold sores, is a major driver of the valacyclovir hydrochloride market. This increase in infections has led to a higher demand for effective antiviral treatments[3].

Growing Awareness and Destigmatization

Growing awareness and the destigmatization of HSV infections have prompted more individuals to seek medical treatment, contributing to the market's growth. This shift in societal attitudes has encouraged people to consult healthcare providers, thereby increasing the demand for valacyclovir hydrochloride[3].

Efficacy and Generic Availability

Valacyclovir hydrochloride's proven efficacy in reducing the frequency and severity of herpes outbreaks has solidified its position in the market. Additionally, the expiration of the patent for valacyclovir has led to the availability of generic versions, making the drug more affordable and accessible to a wider population[3].

Telemedicine and Digital Health Solutions

The integration of telemedicine and online pharmaceutical platforms has facilitated easier access to valacyclovir prescriptions, aligning with the broader trend of digital health solutions. This has expanded the market reach and convenience for patients[3].

Market Segmentation

By Type

The valacyclovir hydrochloride market is segmented based on the type of the drug, with the 98% purity segment accounting for a significant share. This segment is expected to experience substantial growth due to its high efficacy and widespread use[1].

By Application

The market is also segmented by application, with treatments for genital herpes, cold sores, shingles, and chickenpox being the primary uses. Each segment has its own growth trajectory, with genital herpes treatment being a major driver due to its high prevalence[1][5].

Competitive Landscape

The valacyclovir hydrochloride market is highly competitive, with several key players dominating the landscape. These include:

  • Sun Pharmaceutical
  • Yung Zip Chemical
  • Ambeed
  • Atul Ltd
  • BioCrick BioTech
  • BioVision Inc
  • Glentham Life Sciences Limited
  • HuaHai
  • Molekula Group
  • MuseChem
  • Pharmaffiliates
  • Shanghai Pufei Biotechnology
  • Spectrum Chemical[1][4].

These companies are focusing on strategies to strengthen their product portfolios and expand their business globally.

Financial Projections

Capital Investments and Operating Expenses

Setting up a valacyclovir manufacturing plant involves significant capital investments, including costs for machinery, raw materials, and infrastructure. The financial projections for such a project include detailed insights into project economics, such as income and expenditure projections, fixed and variable costs, and expected return on investment (ROI) and net present value (NPV)[3].

Revenue and Volume Forecast

The global valacyclovir hydrochloride market is anticipated to witness a substantial CAGR from 2024 to 2031. The revenue and volume forecasts indicate a steady increase in market size, driven by the factors mentioned above. The market is expected to reach significant figures by the end of the forecast period[1][4].

Cost and Pricing

The cost of valacyclovir hydrochloride can vary based on several factors, including treatment plans, insurance coverage, and the pharmacy used. Generic versions of the drug are generally more affordable than the brand-name version, Valtrex. Financial assistance programs and mail-order pharmacies can also help reduce costs for patients[5].

Regional Analysis

The valacyclovir hydrochloride market is analyzed regionally, with North America, Europe, Asia Pacific, South America, and the Middle East and Africa being key regions. Each region has its own market size and growth rate, influenced by local healthcare policies, prevalence of HSV infections, and access to antiviral medications[1].

Technological and Regulatory Trends

Patent Expiration and Generic Competition

The expiration of the patent for valacyclovir has led to increased competition from generic manufacturers, which has driven down prices and made the drug more accessible. This trend is expected to continue, influencing the market dynamics and financial trajectory of valacyclovir hydrochloride[3].

Regulatory Framework

Regulatory frameworks play a crucial role in the approval and distribution of valacyclovir hydrochloride. Compliance with regulatory standards is essential for manufacturers to ensure the quality and safety of the drug. Changes in regulatory policies can impact the market significantly[1].

Challenges and Opportunities

Drug Resistance

One of the challenges facing the valacyclovir hydrochloride market is the potential development of drug-resistant herpes viruses. This can diminish the effectiveness of the medication over time and pose challenges in managing herpes outbreaks. Regular monitoring and adherence to medical guidance are crucial to mitigate this risk[2].

Side Effects and Safety

Valacyclovir hydrochloride is generally well-tolerated, but long-term use can lead to side effects such as neurotoxicity or nephrotoxicity, especially in individuals with renal impairment. Monitoring for adverse reactions is essential to ensure patient safety[2].

Key Takeaways

  • The global valacyclovir hydrochloride market is driven by the increasing prevalence of HSV infections, growing awareness and destigmatization, and the availability of generic versions.
  • The market is segmented by type and application, with the 98% purity segment and genital herpes treatment being significant drivers.
  • Key players are focusing on strengthening their product portfolios and expanding their business globally.
  • Financial projections indicate a steady increase in market size, driven by growing demand and accessibility.
  • Regional analysis shows varying market sizes and growth rates influenced by local factors.
  • Technological and regulatory trends, such as patent expiration and regulatory compliance, are crucial for market dynamics.

FAQs

What are the primary drivers of the valacyclovir hydrochloride market?

The primary drivers include the increasing prevalence of HSV infections, growing awareness and destigmatization, and the availability of generic versions.

Which segment accounts for the largest share of the global valacyclovir hydrochloride market?

The 98% purity segment accounts for a significant share of the global valacyclovir hydrochloride market.

How does the expiration of the patent for valacyclovir impact the market?

The expiration of the patent has led to increased competition from generic manufacturers, driving down prices and making the drug more accessible.

What are the potential challenges facing the valacyclovir hydrochloride market?

Potential challenges include the development of drug-resistant herpes viruses and side effects associated with long-term use, particularly in individuals with renal impairment.

How can patients reduce the cost of valacyclovir hydrochloride?

Patients can reduce costs by using generic versions, mail-order pharmacies, and financial assistance programs. Getting a 90-day supply of the drug can also help lower costs.

Sources

  1. Cognitiv Market Research: "Valacyclovir HCl Market Report 2024 (Global Edition)"
  2. Legends Recovery: "How Long Does Valacyclovir Stay in Your System?"
  3. IMARC Group: "Valacyclovir (Valtrex) Manufacturing Plant Project Report 2024"
  4. Valuates Reports: "Global Valacyclovir Hydrochloride Market Research Report 2024"
  5. Medical News Today: "Valacyclovir cost 2024: Coupons and more"

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