ACYCLOVIR SODIUM - Generic Drug Details

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

Acyclovir sodium is the generic ingredient in four branded drugs marketed by Abbvie, Eurohlth Intl Sarl, Apothecon, Chartwell Injectable, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hikma, Hospira, Norvium Bioscience, Slate Run Pharma, Teva Parenteral, Zydus Pharms, and Glaxosmithkline, and is included in twenty-two NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for acyclovir sodium. Nine suppliers are listed for this compound.

Summary for ACYCLOVIR SODIUM

US Patents:	0
Tradenames:	4
Applicants:	14
NDAs:	22
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	9
Raw Ingredient (Bulk) Api Vendors:	231
Clinical Trials:	7
Patent Applications:	884
Drug Prices:	Drug price trends for ACYCLOVIR SODIUM
What excipients (inactive ingredients) are in ACYCLOVIR SODIUM?	ACYCLOVIR SODIUM excipients list
DailyMed Link:	ACYCLOVIR SODIUM at DailyMed

See drug prices for ACYCLOVIR SODIUM

Recent Clinical Trials for ACYCLOVIR SODIUM

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

Sponsor	Phase
Sohag University	Phase 4
Alphacait, LLC	Phase 2
Haining Health-Coming Biotech Co., Ltd.	Phase 2

See all ACYCLOVIR SODIUM clinical trials

Pharmacology for ACYCLOVIR SODIUM

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 ACYCLOVIR SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Hikma	ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	205771-002	Feb 29, 2016		DISCN	No	No
Fresenius Kabi Usa	ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	075015-001	Apr 30, 1998		DISCN	No	No
Apothecon	ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	074897-002	Feb 27, 1998		DISCN	No	No
Hospira	ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	074663-001	Apr 22, 1997		DISCN	No	No

Expired US Patents for ACYCLOVIR SODIUM

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Glaxosmithkline	ZOVIRAX	acyclovir sodium	INJECTABLE;INJECTION	018603-001	Oct 22, 1982	4,199,574

ACYCLOVIR SODIUM Market Analysis and Financial Projection Experimental

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