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Last Updated: December 27, 2024

Acyclovir; hydrocortisone - Generic Drug Details


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What are the generic drug sources for acyclovir; hydrocortisone and what is the scope of patent protection?

Acyclovir; hydrocortisone is the generic ingredient in one branded drug marketed by Bausch and is included in one NDA. Additional information is available in the individual branded drug profile pages.

One supplier is listed for this compound.

Summary for acyclovir; hydrocortisone
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Clinical Trials: 4
DailyMed Link:acyclovir; hydrocortisone at DailyMed
Recent Clinical Trials for acyclovir; hydrocortisone

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

SponsorPhase
Assiut UniversityPhase 2
Haining Health-Coming Biotech Co., Ltd.Phase 2
Alphacait, LLCPhase 2

See all acyclovir; hydrocortisone clinical trials

US Patents and Regulatory Information for acyclovir; hydrocortisone

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Bausch XERESE acyclovir; hydrocortisone CREAM;TOPICAL 022436-001 Jul 31, 2009 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Expired US Patents for acyclovir; hydrocortisone

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Bausch XERESE acyclovir; hydrocortisone CREAM;TOPICAL 022436-001 Jul 31, 2009 ⤷  Subscribe ⤷  Subscribe
Bausch XERESE acyclovir; hydrocortisone CREAM;TOPICAL 022436-001 Jul 31, 2009 ⤷  Subscribe ⤷  Subscribe
Bausch XERESE acyclovir; hydrocortisone CREAM;TOPICAL 022436-001 Jul 31, 2009 ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration

Acyclovir; hydrocortisone Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acyclovir and Hydrocortisone in Herpes Labialis Treatment

Market Overview

The global market for herpes labialis (cold sores) treatment is experiencing significant growth, driven by increasing incidence rates, rising awareness of treatment options, and advancements in pharmaceuticals.

Market Size and Growth

  • The herpes labialis treatment market is estimated to grow from USD 1.02 billion in 2024 to USD 1.57 billion by 2031, at a Compound Annual Growth Rate (CAGR) of 6.3%[3].
  • Another forecast indicates that the market will expand from USD 1.13 billion in 2023 to USD 1.79 billion by 2033, with a CAGR of 4.7%[1].

Key Drivers

Increasing Incidence of Herpes Labialis

  • Approximately 3.7 billion people under the age of 50, or 67% of the global population, have HSV-1 infection, which is a primary driver of the market[3].

Growing Demand for Over-the-Counter (OTC) Medications

  • The market is witnessing a surge in demand for OTC medications, particularly topical antiviral drugs like acyclovir and penciclovir, due to their effectiveness and fewer side effects compared to oral antivirals[3].

Advancements in Treatment Options

  • The introduction of new formulations, such as combination therapies and long-acting formulations, is driving market growth. For example, the combination of acyclovir and hydrocortisone in topical creams has shown significant efficacy in reducing the frequency and severity of cold sore outbreaks[5].

Role of Acyclovir

Market Share and Growth

  • Acyclovir is the most commonly prescribed medication for treating cold sores and is projected to expand at a CAGR of 5.1% over the forecast period. Its widespread use is due to its effectiveness in preventing HSV replication, reducing the severity and duration of outbreaks, and easing symptoms[1].

Formulations and Availability

  • Acyclovir is available in various forms, including topical creams, ointments, and oral pills, making it easily accessible to patients. The generic versions of acyclovir, such as those approved by the FDA, further increase its market penetration[1][4].

Role of Hydrocortisone in Combination Therapies

Efficacy in Reducing Inflammation

  • The combination of acyclovir and hydrocortisone in topical creams has been shown to be safe and effective in reducing the frequency of both ulcerative and nonulcerative recurrences of cold sores. This combination also decreases the immune-mediated inflammatory skin reaction associated with HSV infections[5].

Clinical Outcomes

  • Clinical trials have demonstrated that the AHC (acyclovir and hydrocortisone) cream significantly reduces the recurrence of cold sore lesions and shortens healing time compared to acyclovir alone or placebo[5].

Distribution Channels

Hospital Pharmacies

  • Hospitals hold a significant market share, with 35.4% of the distribution in 2022, due to their comprehensive treatment options, expert medical personnel, and inclusion in insurance coverage plans[1].

Retail and Online Pharmacies

  • Retail and online pharmacies also play a crucial role, especially with the increasing adoption of OTC medications. These channels provide easy access to topical treatments like acyclovir and hydrocortisone combinations[3][4].

Regional Dynamics

North America

  • North America dominates the market due to its developed healthcare infrastructure and high disease prevalence in the US and Canada. This region is expected to maintain its dominant position over the forecast period[3][4].

Emerging Markets

  • Countries like China, India, and those in the Asia Pacific region are also significant, with local and international pharmaceutical companies driving competition and innovation. For instance, Livzon Pharmaceutical Group Inc. in China received permission for their acyclovir cream in 2019[1].

Competitive Landscape

Key Players

  • Major players such as GlaxoSmithKline (GSK), Novartis AG, Teva Pharmaceutical US, Inc., AbbVie Inc, and others are actively involved in the market. GSK's exclusive agreement with Medivir for the commercialization of Xerclearâ„¢ (acyclovir and hydrocortisone) is a notable example of strategic partnerships in this sector[2][3].

Strategic Initiatives

  • Companies are focusing on joint ventures, strategic alliances, and regional expansion to gain market share. For example, the launch of generic versions of acyclovir by companies like Amneal Pharmaceuticals and Avet Pharmaceuticals is expanding the market reach of these drugs[4].

Financial Trajectory

Revenue Projections

  • The acyclovir segment is expected to show significant growth due to its acceptance as the gold standard for herpes infection treatment. The market value of acyclovir is projected to increase substantially over the forecast period, driven by frequent approvals and new product launches[4].

Market Penetration

  • The wide availability of generic acyclovir and combination products like AHC cream is expected to fuel market growth. The robust availability of these drugs across the globe, especially in developing countries, is anticipated to increase their market penetration[1][4].

Key Takeaways

  • The herpes labialis treatment market is driven by the increasing incidence of HSV-1 infections and the growing demand for OTC medications.
  • Acyclovir remains a cornerstone in the treatment of cold sores, with its market expected to grow significantly.
  • The combination of acyclovir and hydrocortisone in topical creams has shown promising results in reducing the frequency and severity of cold sore outbreaks.
  • Hospitals and retail pharmacies are key distribution channels, with North America leading the market due to its advanced healthcare infrastructure.
  • Strategic partnerships and the launch of generic versions are crucial for market growth.

FAQs

What is the primary driver of the herpes labialis treatment market?

The primary driver is the increasing incidence of HSV-1 infections globally, affecting approximately 3.7 billion people under the age of 50[3].

Which medication is most commonly prescribed for treating cold sores?

Acyclovir is the most commonly prescribed medication for treating cold sores due to its effectiveness in preventing HSV replication and reducing the severity and duration of outbreaks[1].

What is the significance of the combination of acyclovir and hydrocortisone in treating cold sores?

The combination of acyclovir and hydrocortisone in topical creams reduces the frequency of both ulcerative and nonulcerative recurrences of cold sores and decreases the immune-mediated inflammatory skin reaction associated with HSV infections[5].

Which region dominates the herpes labialis treatment market?

North America dominates the market due to its developed healthcare infrastructure and high disease prevalence in the US and Canada[3][4].

What are the key distribution channels for herpes labialis treatments?

Hospitals, retail pharmacies, and online pharmacies are the key distribution channels, with hospitals holding a significant market share due to their comprehensive treatment options and inclusion in insurance coverage plans[1][3].

Sources

  1. Future Market Insights: Herpes Labialis Treatment Market Opportunities 2023 to 2033
  2. GlaxoSmithKline: GlaxoSmithKline enters agreement with Medivir for exclusive rights to cold sore treatment Xerclearâ„¢
  3. GlobeNewswire: Cold Sore Treatment Market Size to Reach $1.57 Billion by 2031 Globally at a 6.3% CAGR
  4. Grand View Research: Herpes Simplex Virus Treatment Market Size Report, 2030
  5. PubMed: The role of topical 5% acyclovir and 1% hydrocortisone cream in the early treatment of recurrent herpes simplex labialis.

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