Acyclovir - Generic Drug Details

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

Acyclovir is the generic ingredient in seven branded drugs marketed by Actavis Elizabeth, Adaptis, Apotex, Aurobindo Pharma Usa, Cadila, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Heritage, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Ranbaxy, Roxane, Strides Pharma, Teva, Teva Pharms, Watson Labs, Yiling, Norvium Bioscience, Alembic, Amneal, Padagis Israel, Taro, Zydus Lifesciences, Bausch, Fera Pharms Llc, Amneal Pharms, Anda Repository, Chartwell Rx, Cipla, Cosette, Fougera Pharms Inc, Glenmark Speclt, Macleods Pharms Ltd, Mylan Pharms Inc, Prinston Inc, Torrent, Xiromed, Actavis Mid Atlantic, Aurobindo Pharma, Hetero Labs Ltd Iii, Hikma, MSN, Novitium Pharma, Rubicon, Vistapharm Llc, Lnhc, Apotex Inc, Carlsbad, Hetero Labs Ltd V, Square Pharms, Sun Pharm Inds Ltd, Zydus Pharms, Abbvie, Eurohlth Intl Sarl, Apothecon, Chartwell Injectable, Dr Reddys, Eugia Pharma, Fresenius Kabi Usa, Hospira, Slate Run Pharma, Teva Parenteral, and Glaxosmithkline, and is included in ninety-nine NDAs. There are three patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Acyclovir has forty-six patent family members in twenty-nine countries.

There are fifty-six drug master file entries for acyclovir. Sixty-nine suppliers are listed for this compound. There are three tentative approvals for this compound.

Summary for acyclovir

International Patents:	46
US Patents:	3
Tradenames:	7
Applicants:	65
NDAs:	99
Drug Master File Entries:	56
Finished Product Suppliers / Packagers:	69
Raw Ingredient (Bulk) Api Vendors:	185
Clinical Trials:	130
Patent Applications:	5,902
Drug Prices:	Drug price trends for acyclovir
Drug Sales Revenues:	Drug sales revenues for acyclovir
What excipients (inactive ingredients) are in acyclovir?	acyclovir excipients list
DailyMed Link:	acyclovir at DailyMed

See drug prices for acyclovir

See drug sales revenues for acyclovir

Recent Clinical Trials for acyclovir

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

Sponsor	Phase
Jena University Hospital	Phase 3
Medical University of South Carolina	Phase 4
Takeda	Phase 4

See all acyclovir clinical trials

Generic filers with tentative approvals for ACYCLOVIR

Applicant	Application No.	Strength	Dosage Form
		200MG	CAPSULE;ORAL
		400MG	TABLET;ORAL
		800MG	TABLET;ORAL

The 'tentative' approval signifies that the product meets all FDA standards for marketing, and, but for the patents / regulatory protections, it would approved.

Pharmacology for acyclovir

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

Medical Subject Heading (MeSH) Categories for acyclovir

Antiviral Agents

US Patents and Regulatory Information for acyclovir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Teva Parenteral	ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	075627-001	Mar 28, 2001		DISCN	No	No
Strides Pharma	ACYCLOVIR	acyclovir	CAPSULE;ORAL	074833-001	Apr 22, 1997		DISCN	No	No
Apothecon	ACYCLOVIR SODIUM	acyclovir sodium	INJECTABLE;INJECTION	074897-002	Feb 27, 1998		DISCN	No	No
Teva Pharms	ACYCLOVIR	acyclovir	TABLET;ORAL	075021-001	Mar 18, 1998		DISCN	No	No
Chartwell Molecules	ACYCLOVIR	acyclovir	TABLET;ORAL	074834-002	Apr 24, 1997		DISCN	No	No
Aurobindo Pharma Usa	ACYCLOVIR	acyclovir	TABLET;ORAL	075211-002	Sep 28, 1998		DISCN	No	No
Eurohlth Intl Sarl	ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE	acyclovir sodium	INJECTABLE;INJECTION	074885-002	Dec 19, 1997		DISCN	No	No

Expired US Patents for acyclovir

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Norvium Bioscience	ZOVIRAX	acyclovir	TABLET;ORAL	020089-002	Apr 30, 1991	4,199,574
Norvium Bioscience	ZOVIRAX	acyclovir	CAPSULE;ORAL	018828-001	Jan 25, 1985	4,199,574
Norvium Bioscience	ZOVIRAX	acyclovir	TABLET;ORAL	020089-001	Apr 30, 1991	4,199,574
Bausch	ZOVIRAX	acyclovir	OINTMENT;TOPICAL	018604-001	Mar 29, 1982	4,199,574
Bausch	ZOVIRAX	acyclovir	CREAM;TOPICAL	021478-001	Dec 30, 2002	4,963,555

International Patents for acyclovir

Country	Patent Number	Title	Estimated Expiration
Turkey	201810146
Serbia	57430	MUKOADHEZIVNE BUKALNE TABLETE ZA LEČENJE OROFACIJALNOG HERPESA (MUCOADHESIVE BUCCAL TABLETS FOR THE TREATMENT OF OROFACIAL HERPES)
Denmark	2509586
Brazil	PI0709057	veìculo mucoso bioadesivo de lenta liberação, método para preparar um veìculo mucoso bioadesivo de lenta liberação, e, uso do véiculo mucoso bioadesivo de lenta liberação
Portugal	2509586
South Korea	101335185
Portugal	1998750

Supplementary Protection Certificates for acyclovir

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

Acyclovir Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Acyclovir

Introduction

Acyclovir, an antiviral medication, has been a cornerstone in the treatment of various viral infections, including herpes simplex virus (HSV) and varicella-zoster virus (VZV). The market for Acyclovir is driven by several key factors, including the increasing prevalence of viral infections, advancements in formulation technologies, and a growing demand for effective antiviral treatments.

Market Size and Growth

The Acyclovir market is projected to experience significant growth over the coming years. As of 2023, the market size was valued at USD 3.2 billion 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].

Regional Market Dynamics

North America

North America dominates the Acyclovir market, accounting for approximately 40-44% of the global revenue. This dominance is attributed to the high prevalence of HSV infections, including genital herpes and cold sores, as well as the region's well-established healthcare infrastructure and advanced medical facilities. The North American market is expected to grow at a CAGR of 4.2% from 2024 to 2031[4].

Asia-Pacific

The Asia-Pacific region is emerging as the fastest-growing market for Acyclovir. This growth is driven by a large population base, particularly in countries like China and India, where the prevalence of HSV infections is significant. Improving healthcare infrastructure and rising healthcare expenditure in the region further enhance access to Acyclovir treatments, contributing to market expansion. The Asia-Pacific market is expected to grow at a CAGR of 8% from 2024 to 2031[4].

Europe

Europe also plays a vital role in the Acyclovir market, driven by advanced healthcare infrastructure, extensive research and development activities, and stringent regulatory frameworks. The European market is expected to grow at a CAGR of 4.5% from 2024 to 2031[4].

Other Regions

Other regions, including South America and the Middle East and Africa, are also experiencing growth, albeit at a slower pace. The South American market is expected to grow at a CAGR of 5.4%, while the Middle East and Africa region is expected to grow at a CAGR of 5.7% from 2024 to 2031[4].

Key Drivers of Market Growth

Increasing Prevalence of Viral Infections

The rising prevalence of viral infections, particularly HSV and VZV, is a significant driver of the Acyclovir market. As awareness of antiviral treatments expands, healthcare providers are increasingly prescribing Acyclovir for the effective management of these conditions[3].

Technological Advancements

Advancements in formulation technologies, such as the introduction of nanotechnology to develop antiviral medications, are enhancing the efficacy and patient adherence to Acyclovir treatments. These innovations are expected to continue driving market growth[1].

Growing Immunocompromised Population

The rise in immunocompromised populations, such as those with HIV/AIDS or undergoing chemotherapy, is contributing to the demand for Acyclovir as a preventive measure. This demographic trend is expected to sustain market growth in the coming years[3].

Healthcare Infrastructure and Expenditure

Well-established healthcare infrastructure and increasing healthcare expenditure in key regions are facilitating the diagnosis and treatment of viral infections, thereby driving the demand for Acyclovir[1][4].

Market Segmentation

Application

The Acyclovir market is segmented based on application, including tablets, cream, suspension, and injection. The market can also be categorized based on the type of viral infection treated, such as HSV, VZV, and others. HSV holds the largest share due to the high prevalence of herpes infections[3].

Product

The market is further segmented by product, including treatments for herpes simplex virus, varicella-zoster virus, and shingles. These segments are driven by the specific needs of different patient populations and the efficacy of Acyclovir in treating these conditions[3].

Key Players

The global Acyclovir market is competitive, with several key players operating in the sector. These include:

• Agio Pharmaceuticals Limited (India)
• Synmedic Laboratories (India)
• Zee Laboratories Ltd (India)
• Cipla Inc. (India)
• Bhavishya Pharmaceuticals Pvt Ltd
• Geo Pharma Pvt Ltd (Georgia)
• Finecure Pharmaceuticals Ltd (India)
• Novus Life Sciences Pvt Ltd (India)
• Talent Laboratories (India)
• Adley Formulation (India)[1]

Recent Developments

Recent approvals and launches have further bolstered the market. For instance, Amneal Pharmaceuticals received FDA approval for its Abbreviated New Drug Application (ANDA) for Acyclovir Cream, 5%, which is the generic version of Zovirax® for treating recurrent herpes labialis (cold sores) in immunocompetent adults and adolescents 12 years of age and older[2].

Financial Performance

The financial performance of the Acyclovir market is robust, with significant revenue generated from the sales of Acyclovir products. For example, U.S. annual sales for Acyclovir Cream, 5%, were approximately $67 million for the 12 months ended September 2020[2].

Challenges and Opportunities

While the market faces challenges such as regulatory hurdles and competition from other antiviral medications, it also presents several opportunities. The growing awareness of viral infections and the need for effective treatments, especially in emerging markets, offer a promising landscape for market expansion.

"The Acyclovir market is experiencing notable growth, driven by the increasing prevalence of viral infections, particularly herpes simplex virus (HSV) and varicella-zoster virus (VZV). As awareness of antiviral treatments expands, healthcare providers are increasingly prescribing Acyclovir for effective management of these conditions."[3]

Conclusion

The Acyclovir market is poised for significant growth driven by increasing demand for antiviral treatments, technological advancements, and improving healthcare infrastructure. Key regions such as North America and Asia-Pacific are expected to drive this growth, with other regions also contributing to the market's expansion.

Key Takeaways

• The Acyclovir market is projected to grow from USD 3.2 billion in 2023 to USD 5.1 billion by 2031.
• North America and Asia-Pacific are the dominant and fastest-growing regions, respectively.
• The market is driven by the increasing prevalence of viral infections, technological advancements, and growing healthcare expenditure.
• Key players include several pharmaceutical companies with a strong presence in India and other regions.
• Recent approvals and launches of generic and innovative formulations are enhancing market growth.

FAQs

What are the primary drivers of the Acyclovir market?

The primary drivers include the increasing prevalence of viral infections, technological advancements in formulation, and growing healthcare expenditure.

Which regions are expected to drive the growth of the Acyclovir market?

North America and Asia-Pacific are expected to be the dominant and fastest-growing regions, respectively.

What is the projected market size of Acyclovir by 2031?

The market is expected to reach USD 5.1 billion by 2031.

Who are the key players in the global Acyclovir market?

Key players include Agio Pharmaceuticals Limited, Synmedic Laboratories, Zee Laboratories Ltd, Cipla Inc., and others.

What recent developments have impacted the Acyclovir market?

Recent FDA approvals for generic versions of Acyclovir, such as Amneal Pharmaceuticals' Acyclovir Cream, 5%, have contributed to market growth.

Sources

1. Stratview Research - Acyclovir Market Size, Share & Forecast Analysis (2021-2026)
2. Amneal Pharmaceuticals - Amneal Receives Abbreviated New Drug Application Approval for Acyclovir Cream, 5%
3. Market Research Intellect - Acyclovir Market Size and Projections
4. Cognitive Market Research - Acyclovir Market Report