ZOVIRAX Drug Patent Profile

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

Zovirax is a drug marketed by Norvium Bioscience, Bausch, and Glaxosmithkline. and is included in six NDAs.

The generic ingredient in ZOVIRAX 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 Zovirax

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

Summary for ZOVIRAX

US Patents:	0
Applicants:	3
NDAs:	6
Finished Product Suppliers / Packagers:	3
Raw Ingredient (Bulk) Api Vendors:	185
Clinical Trials:	12
Patent Applications:	531
Drug Prices:	Drug price information for ZOVIRAX
What excipients (inactive ingredients) are in ZOVIRAX?	ZOVIRAX excipients list
DailyMed Link:	ZOVIRAX at DailyMed

See drug prices for ZOVIRAX

Recent Clinical Trials for ZOVIRAX

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

Sponsor	Phase
PT. Kimia Farma (Persero) Tbk	N/A
PT Pharma Metric Labs	N/A
Squarex, LLC	Phase 2

See all ZOVIRAX clinical trials

Pharmacology for ZOVIRAX

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 ZOVIRAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Norvium Bioscience	ZOVIRAX	acyclovir	CAPSULE;ORAL	018828-001	Jan 25, 1985		DISCN	Yes	No
Norvium Bioscience	ZOVIRAX	acyclovir	SUSPENSION;ORAL	019909-001	Dec 22, 1989		DISCN	Yes	No
Glaxosmithkline	ZOVIRAX	acyclovir sodium	INJECTABLE;INJECTION	018603-003	Aug 30, 1983		DISCN	Yes	No
Norvium Bioscience	ZOVIRAX	acyclovir	TABLET;ORAL	020089-001	Apr 30, 1991		DISCN	Yes	No
Bausch	ZOVIRAX	acyclovir	CREAM;TOPICAL	021478-001	Dec 30, 2002	AB	RX	Yes	No
Glaxosmithkline	ZOVIRAX	acyclovir sodium	INJECTABLE;INJECTION	018603-002	Jun 29, 1989		DISCN	Yes	No

Expired US Patents for ZOVIRAX

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norvium Bioscience	ZOVIRAX	acyclovir	CAPSULE;ORAL	018828-001	Jan 25, 1985
Norvium Bioscience	ZOVIRAX	acyclovir	TABLET;ORAL	020089-001	Apr 30, 1991
Bausch	ZOVIRAX	acyclovir	OINTMENT;TOPICAL	018604-001	Mar 29, 1982
Bausch	ZOVIRAX	acyclovir	CREAM;TOPICAL	021478-001	Dec 30, 2002
Glaxosmithkline	ZOVIRAX	acyclovir sodium	INJECTABLE;INJECTION	018603-001	Oct 22, 1982
Norvium Bioscience	ZOVIRAX	acyclovir	TABLET;ORAL	020089-002	Apr 30, 1991

International Patents for ZOVIRAX

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

Country	Patent Number	Title	Estimated Expiration
Belgium	833006
Japan	S52106896	SUBSTITUTED PURINE AND PROCESS FOR PREPARING SAME
Singapore	72085
Denmark	146595
Spain	455979
Hungary	176730	PROCESS FOR PRODUCING 9-SUBSTITUTED-PURINE DERIVATIVES AND SALTS

Supplementary Protection Certificates for ZOVIRAX

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0809498	10C0038	France		PRODUCT NAME: ACYCLOVIR ET HYDROCORTISONE; NAT. REGISTRATION NO/DATE: NL 36 826 20100420; FIRST REGISTRATION: SK - 2108/08467-R 20091026
0809498	SPC/GB10/012	United Kingdom		PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112

ZOVIRAX Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for Zovirax (Acyclovir)

Introduction

Zovirax, commonly known by its generic name acyclovir, is a pivotal antiviral medication used to treat various viral infections, including herpes simplex virus (HSV) and varicella-zoster virus (VZV), which causes chickenpox and shingles. Here, we delve into the market dynamics and financial trajectory of Zovirax, highlighting its current status, growth prospects, and key factors influencing its market.

Market Size and Growth

The global market for varicella zoster infection treatment, in which acyclovir is a dominant player, was valued at over USD 1.5 billion in 2020 and is projected to reach USD 2.0 billion by 2028, growing at a Compound Annual Growth Rate (CAGR) of 4.1% during this period[1].

Market Share of Acyclovir

Acyclovir holds a substantial share of the varicella zoster infection treatment market, accounting for over 55.7% of the market in 2022. This dominance is expected to continue, driven by its efficacy as a first-line treatment for these infections[1].

Geographical Distribution

The demand for acyclovir is significant across various regions, with the top five countries (USA, China, Japan, Germany, and the UK) constituting nearly 52.3% of the global market share. Western Europe, particularly Germany, is forecasted to grow at a CAGR of 3.6% between 2022 and 2028[1].

Application and Product Segments

The acyclovir market is segmented based on application (tablets, cream, suspension, injection) and product (herpes simplex virus treatment, varicella-zoster virus treatment, shingles). The market size for acyclovir was valued at USD 3.2 billion in 2023 and is expected to reach USD 5.1 billion by 2031, growing at a CAGR of 5.8% from 2024 to 2031[4].

Driving Factors

Several factors are driving the growth of the acyclovir market:

• Increasing Incidence of Viral Infections: The rising prevalence of herpes simplex virus and varicella-zoster virus infections, particularly among children and the elderly, is a significant driver[1][4].
• Growing Focus on Clinical Development: Efforts to develop more effective antiviral drugs and improve treatment outcomes are boosting market growth[1].
• Economic Burden Mitigation: Concerted efforts to reduce the economic burden of varicella zoster virus infections also contribute to the demand for acyclovir[1].
• Immunocompromised Populations: The increasing number of immunocompromised individuals, such as those with HIV/AIDS or undergoing chemotherapy, further drives the demand for acyclovir as a preventive measure[4].

Challenges and Declines

Despite the overall growth, the market faces some challenges:

• Adverse Effects: The adverse effects of antiviral therapy, including neurological, gastrointestinal, and renal toxicity, have led to a decline in Basis Point Share (BPS) in certain periods[1].
• Market Fluctuations: The market observed a decline in 10 BPS in H1-2022 outlook compared to H1-2022 projected period, attributed to these adverse effects and other market dynamics[1].

Key Players and Market Strategies

Major pharmaceutical companies such as Novartis AG, Pfizer Inc., Abbott Laboratories, Sun Pharmaceuticals Industries Ltd., and GlaxoSmithKline plc are key players in the acyclovir market. These companies are focusing on organic and inorganic growth strategies, including product launches, acquisitions, and expansion of product portfolios and research & development capabilities to gain maximum market share[1].

Financial Performance

The financial performance of companies involved in the acyclovir market reflects the overall market trends. For instance, GlaxoSmithKline (GSK) reported strong growth in pharmaceutical sales, partly offset by higher supply chain costs and increased investment in R&D. The adjusted operating profit for GSK increased by 9% on a constant currency basis, reflecting positive leverage from sales and cost control measures[5].

Future Outlook

The acyclovir market is expected to witness sustained growth due to ongoing advancements in formulation technologies and a focus on improving patient adherence. The increasing awareness of antiviral treatments and the expanding prescription base by healthcare providers will continue to drive the market forward[4].

Key Takeaways

• The global varicella zoster infection treatment market, dominated by acyclovir, is projected to grow from USD 1.5 billion in 2020 to USD 2.0 billion by 2028.
• Acyclovir holds over 55.7% of the market share and is expected to remain a first-line treatment.
• The market is driven by increasing viral infections, clinical development, and economic burden mitigation.
• Key players are focusing on organic and inorganic growth strategies.
• The market faces challenges such as adverse effects of antiviral therapy.

FAQs

What is the current market size of the varicella zoster infection treatment market?

The global varicella zoster infection treatment market was valued at over USD 1.5 billion in 2020 and is projected to reach USD 2.0 billion by 2028[1].

What is the market share of acyclovir in the varicella zoster infection treatment market?

Acyclovir holds a substantial share of over 55.7% in the overall varicella zoster infection treatment market as of 2022[1].

Which regions are driving the demand for acyclovir?

The top five countries (USA, China, Japan, Germany, and the UK) constitute nearly 52.3% of the global market share, with Western Europe, particularly Germany, showing significant growth[1].

What are the key factors driving the growth of the acyclovir market?

The growth is driven by increasing viral infections, growing focus on clinical development, mitigation of the economic burden of varicella zoster virus infections, and the rising number of immunocompromised populations[1][4].

How is the acyclovir market expected to grow in the future?

The acyclovir market is expected to grow at a CAGR of 5.8% from 2024 to 2031, reaching a value of USD 5.1 billion by 2031, driven by advancements in formulation technologies and increasing awareness of antiviral treatments[4].

Which companies are key players in the acyclovir market?

Key players include Novartis AG, Pfizer Inc., Abbott Laboratories, Sun Pharmaceuticals Industries Ltd., and GlaxoSmithKline plc, among others[1].

Sources

1. Future Market Insights, "Varicella Zoster Infection Treatment Market Trends & Share | FMI"
2. Bausch Health Companies Inc., "4Q & FY 2021 - Financial Results"
3. PharmGKB, "Acyclovir/Ganciclovir Pathway, Pharmacokinetics/Pharmacodynamics"
4. Market Research Intellect, "Acyclovir Market Size and Projections"
5. GlaxoSmithKline, "Full year and fourth quarter 2021 - GSK"