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Last Updated: March 17, 2025

ACYCLOVIR - Generic Drug Details


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What are the generic 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, 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-four suppliers are listed for this compound. There are three tentative approvals for this compound.

Drug Prices for ACYCLOVIR

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Drug Sales Revenue Trends for ACYCLOVIR

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Recent Clinical Trials for ACYCLOVIR

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SponsorPhase
Jena University HospitalPhase 3
Medical University of South CarolinaPhase 4
TakedaPhase 4

See all ACYCLOVIR clinical trials

Generic filers with tentative approvals for ACYCLOVIR
Applicant Application No. Strength Dosage Form
⤷  Try for Free⤷  Try for Free200MGCAPSULE;ORAL
⤷  Try for Free⤷  Try for Free800MGTABLET;ORAL
⤷  Try for Free⤷  Try for Free400MGTABLET;ORAL

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

Medical Subject Heading (MeSH) Categories for ACYCLOVIR

US Patents and Regulatory Information for ACYCLOVIR

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
Carlsbad ACYCLOVIR acyclovir TABLET;ORAL 075382-001 Apr 30, 1999 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Carlsbad ACYCLOVIR acyclovir TABLET;ORAL 075382-002 Apr 30, 1999 AB RX No No ⤷  Try for Free ⤷  Try for Free ⤷  Try for Free
Square Pharms ACYCLOVIR acyclovir TABLET;ORAL 209366-001 Oct 7, 2019 AB RX 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 4 of 4 entries

Expired US Patents for ACYCLOVIR

ApplicantTradenameGeneric NameDosageNDAApproval DatePatent No.Patent Expiration
Norvium Bioscience ZOVIRAX acyclovir CAPSULE;ORAL 018828-001 Jan 25, 1985 ⤷  Try for Free ⤷  Try for Free
Norvium Bioscience ZOVIRAX acyclovir TABLET;ORAL 020089-002 Apr 30, 1991 ⤷  Try for Free ⤷  Try for Free
Norvium Bioscience ZOVIRAX acyclovir TABLET;ORAL 020089-001 Apr 30, 1991 ⤷  Try for Free ⤷  Try for Free
Bausch ZOVIRAX acyclovir CREAM;TOPICAL 021478-001 Dec 30, 2002 ⤷  Try for Free ⤷  Try for Free
>Applicant>Tradename>Generic Name>Dosage>NDA>Approval Date>Patent No.>Patent Expiration
Showing 1 to 4 of 4 entries

International Patents for ACYCLOVIR

CountryPatent NumberTitleEstimated Expiration
European Patent Office 2216017 VEHICULE BIOADHESIF POUR LES MUQUEUSES POUR DELIVRER LENTEMENT DES PRINCIPES ACTIFS (Mucosal bioadhesive slow release carrier for delivering active principles) ⤷  Try for Free
Mexico 2008012186 PORTADOR BIOADHESIVO MUCOSAL DE LIBERACION RETARDADA PARA EL SUMINISTRO DEL PRINCIPIO ACTIVO. (MUCOSAL BIOADHESIVE SLOW RELEASE CARRIER FOR DELIVERING ACTIVE PRINCIPLES.) ⤷  Try for Free
Serbia 51342 MUKOZNI BIOADHEZIVNI NOSAČ ZA SPORO OSLOBAĐANJE AKTIVNIH SUPSTANCI (MUCOSAL BIOADHESIVE SLOW RELEASE CARRIER FOR DELIVERING ACTIVE PRINCIPLES) ⤷  Try for Free
World Intellectual Property Organization (WIPO) 2007110778 ⤷  Try for Free
>Country>Patent Number>Title>Estimated Expiration
Showing 1 to 4 of 4 entries

Supplementary Protection Certificates for ACYCLOVIR

Patent NumberSupplementary Protection CertificateSPC CountrySPC ExpirationSPC Description
0809498 10C0038 France ⤷  Try for Free 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 ⤷  Try for Free PRODUCT NAME: A COMBINATION OF ACYCLOVIR AND HYDROCORTISONE; REGISTERED: UK PL18191/0001-0001 20091112
>Patent Number>Supplementary Protection Certificate>SPC Country>SPC Expiration>SPC Description
Showing 1 to 2 of 2 entries

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

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