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Last Updated: March 15, 2025

ACYCLOVIR SODIUM Drug Patent Profile


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When do Acyclovir Sodium patents expire, and when can generic versions of Acyclovir Sodium launch?

Acyclovir Sodium is a drug marketed by Apothecon, Chartwell Injectable, Dr Reddys, Eugia Pharma, Eurohlth Intl Sarl, Fresenius Kabi Usa, Hikma, Hospira, Norvium Bioscience, Slate Run Pharma, Teva Parenteral, and Zydus Pharms. and is included in nineteen NDAs.

The generic ingredient in ACYCLOVIR SODIUM is acyclovir sodium. There are fifty-six drug master file entries for this compound. Nine suppliers are listed for this compound. Additional details are available on the acyclovir sodium profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Acyclovir Sodium

A generic version of ACYCLOVIR SODIUM was approved as acyclovir sodium by FRESENIUS KABI USA on May 13th, 1998.

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Recent Clinical Trials for ACYCLOVIR SODIUM

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SponsorPhase
Sohag UniversityPhase 4
Haining Health-Coming Biotech Co., Ltd.Phase 2
Alphacait, LLCPhase 2

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US Patents and Regulatory Information for ACYCLOVIR SODIUM

ApplicantTradenameGeneric NameDosageNDAApproval DateTETypeRLDRSPatent No.Patent ExpirationProductSubstanceDelist Req.Exclusivity Expiration
Chartwell Injectable ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 074596-002 Apr 22, 1997 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Hospira ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 074663-001 Apr 22, 1997 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Apothecon ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 074897-002 Feb 27, 1998 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Eurohlth Intl Sarl ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 074913-002 Oct 15, 1997 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Teva Parenteral ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 075627-001 Mar 28, 2001 DISCN No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Zydus Pharms ACYCLOVIR SODIUM acyclovir sodium INJECTABLE;INJECTION 206606-001 Jun 13, 2017 DISCN 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 6 of 6 entries

Market Dynamics and Financial Trajectory for Acyclovir Sodium

Market Overview

Acyclovir sodium, a synthetic nucleoside analog used to treat herpes simplex virus (HSV) and varicella-zoster virus (VZV) infections, is experiencing significant growth in the global market. Here are the key dynamics and financial projections for this drug.

Market Size and Growth

The global acyclovir market was valued at USD 3.2 billion in 2023 and is expected to reach USD 5.1 billion by 2031, growing at a Compound Annual Growth Rate (CAGR) of 5.8% from 2024 to 2031[3].

For the acyclovir sodium injection market specifically, it was valued at USD 1.29 billion in 2023 and is projected to reach USD 2.1179 billion by 2030, with a CAGR of 7.4% during the forecast period[1].

Drivers of Growth

Several factors are driving the growth of the acyclovir market:

Increasing Prevalence of Viral Infections

The rising incidence of herpes simplex virus and varicella-zoster virus infections is a major driver. As these infections become more prevalent, the demand for effective antiviral therapies like acyclovir increases[3].

Growing Healthcare Access and Awareness

Improved healthcare access and increasing awareness about antiviral treatments are leading to higher prescription rates of acyclovir. This is particularly true in regions where healthcare infrastructure is expanding[3].

Advancements in Formulation Technologies

Ongoing research and development aimed at improving acyclovir formulations are enhancing its effectiveness and patient compliance. New formulations, such as those with better bioavailability (like valacyclovir, a prodrug of acyclovir), are contributing to market growth[2].

Expansion of Online Pharmacies and Telemedicine

The rise of online pharmacies and telemedicine services is making antiviral medications, including acyclovir, more accessible to a wider population, further driving market growth[3].

Market Segmentation

The acyclovir market is segmented based on several criteria:

By Application

  • Tablets
  • Cream
  • Suspension
  • Injection

The injection form, particularly acyclovir sodium injection, is crucial for severe cases requiring intravenous administration[3].

By Product

  • Herpes simplex virus treatment
  • Varicella-zoster virus treatment
  • Shingles treatment

Each of these segments contributes significantly to the overall market size and growth[3].

By Geography

  • North America
  • Europe
  • Asia-Pacific
  • South America
  • Middle East and Africa

Regional differences in healthcare infrastructure, disease prevalence, and regulatory environments influence market dynamics[3].

Financial Projections

Revenue Forecast

The global acyclovir market is expected to grow from USD 3.2 billion in 2023 to USD 5.1 billion by 2031. For the acyclovir sodium injection market, the revenue is projected to increase from USD 1.29 billion in 2023 to USD 2.1179 billion by 2030[1][3].

Key Players

Major pharmaceutical companies such as GlaxoSmithKline, Teva Pharmaceuticals, Mylan, Sandoz, Zydus Pharmaceuticals, and Dr. Reddy’s are key players in the acyclovir market. These companies are driving innovation and market expansion through various strategies, including new formulations and distribution channels[3].

Challenges and Considerations

Renal Impairment and Nephrotoxicity

Acyclovir, especially when administered intravenously, can cause acute kidney injury due to crystal formation in the renal tubules. Patients with renal impairment, obesity, or those receiving concomitant nephrotoxic drugs are at higher risk. This necessitates careful monitoring and dose adjustments based on renal function[2].

Viral Resistance

The possibility of viral resistance to acyclovir should be considered, especially in patients showing poor clinical response during therapy. This can lead to the need for alternative treatments and impacts the long-term efficacy of acyclovir[5].

Pharmacokinetics and Safety

Pharmacokinetics

Acyclovir demonstrates dose-independent linear pharmacokinetics when administered intravenously. It has low plasma protein binding and can penetrate the blood-brain barrier. The mean half-life ranges from 2.5 to 3 hours in patients with normal renal function, but this can be significantly prolonged in patients with renal impairment[2][5].

Safety Profile

Acyclovir is generally well-tolerated, but it can cause adverse effects such as acute kidney injury, particularly in high-risk patients. Appropriate cautions and monitoring are necessary to mitigate these risks[2].

Key Takeaways

  • The global acyclovir market is expected to grow significantly, driven by increasing viral infections, improved healthcare access, and advancements in formulation technologies.
  • The acyclovir sodium injection market is projected to reach USD 2.1179 billion by 2030, growing at a CAGR of 7.4%.
  • Key players are driving innovation and market expansion through new formulations and distribution channels.
  • Careful monitoring and dose adjustments are necessary due to the risk of renal impairment and nephrotoxicity.
  • Viral resistance is a consideration that may impact long-term efficacy.

FAQs

Q: What is the current market size of the global acyclovir market?

A: The global acyclovir market was valued at USD 3.2 billion in 2023[3].

Q: What is the projected growth rate of the acyclovir sodium injection market?

A: The acyclovir sodium injection market is expected to grow at a CAGR of 7.4% from 2024 to 2030[1].

Q: What are the main drivers of the acyclovir market growth?

A: The main drivers include the increasing prevalence of viral infections, growing healthcare access and awareness, advancements in formulation technologies, and the expansion of online pharmacies and telemedicine services[3].

Q: What are the potential risks associated with intravenous acyclovir administration?

A: The main risks include acute kidney injury due to crystal formation in the renal tubules, particularly in patients with renal impairment, obesity, or those receiving concomitant nephrotoxic drugs[2].

Q: How does renal function impact the pharmacokinetics of acyclovir?

A: Renal function significantly affects the half-life and total body clearance of acyclovir. Patients with impaired renal function may experience prolonged half-lives, necessitating dose adjustments[2][5].

Sources

  1. Global Acyclovir Sodium Injection Market Research Report 2024 - Valuates Reports
  2. Acyclovir - StatPearls - NCBI Bookshelf - NCBI
  3. Acyclovir Market Size and Projections - Market Research Intellect - Market Research Intellect
  4. Acyclovir Sodium Injection Market Size, Scope And Forecast Report - Market Research Intellect
  5. ZOVIRAX - accessdata.fda.gov - FDA

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