ACYCLOVIR - Generic Drug Details

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, Apotex, Aurobindo Pharma Usa, Cadila, Cadila Pharms Ltd, Carlsbad Technology, Chartwell Molecules, Heritage, Ivax Sub Teva Pharms, Lek Pharm, Mylan, Ranbaxy, Regcon Holdings, Roxane, Strides Pharma Intl, Teva, Teva Pharms, Watson Labs, Yiling, Pharmobedient, Alembic, Amneal, Cipla, Padagis Israel, Sun Pharma Canada, Zydus Lifesciences, Bausch, Fera Pharms Llc, Amneal Pharms, Chartwell Molecular, Chartwell Rx, 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 Research, Vistapharm Llc, Ligand Pharms, 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 one hundred 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-two 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:	63
NDAs:	100
Drug Master File Entries:	56
Finished Product Suppliers / Packagers:	62
Raw Ingredient (Bulk) Api Vendors:	1
Clinical Trials:	143
Patent Applications:	6,453
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
Columbia University	PHASE2
Cornell University	PHASE2
Cairo University	PHASE4

See all ACYCLOVIR clinical trials

Generic filers with tentative approvals for ACYCLOVIR

Applicant	Application No.	Strength	Dosage Form
		200MG	CAPSULE;ORAL
		800MG	TABLET;ORAL
		400MG	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
Ranbaxy	ACYCLOVIR	acyclovir	CAPSULE;ORAL	074975-001	Sep 30, 1998		DISCN	No	No
Strides Pharma Intl	ACYCLOVIR	acyclovir	TABLET;ORAL	074946-002	Nov 19, 1997	AB	RX	No	No
Sun Pharm Inds Ltd	ACYCLOVIR	acyclovir	TABLET;ORAL	074980-001	Sep 30, 1998		DISCN	No	No

Expired US Patents for ACYCLOVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Pharmobedient	ZOVIRAX	acyclovir	CAPSULE;ORAL	018828-001	Jan 25, 1985	4,199,574
Pharmobedient	ZOVIRAX	acyclovir	TABLET;ORAL	020089-001	Apr 30, 1991	4,199,574
Pharmobedient	ZOVIRAX	acyclovir	TABLET;ORAL	020089-002	Apr 30, 1991	4,199,574

International Patents for ACYCLOVIR

Country	Patent Number	Title	Estimated Expiration
Poland	2509586
Argentina	060085
Austria	E446743

Supplementary Protection Certificates for ACYCLOVIR

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

Market Dynamics and Financial Trajectory for Acyclovir: An In-Depth Analysis

Last updated: December 3, 2025

Summary

Acyclovir, a pioneering antiviral medication developed by GlaxoSmithKline (GSK) in the 1970s, has maintained a significant market position in the treatment of herpes simplex virus (HSV) and varicella-zoster virus (VZV) infections. This analysis explores the current market landscape, factors influencing its financial trajectory, competitive dynamics, and future outlook.

Key insights include:

• The global acyclovir market was valued at approximately USD 1.2 billion in 2022, with steady compound annual growth rate (CAGR) projections of 3-4% over the next five years.
• Increasing prevalence of herpesvirus infections, growing aging populations, and expanding healthcare access are primary drivers.
• Patent expirations, generic competition, and evolving antiviral therapies influence revenue streams.
• Emerging regions such as Asia-Pacific present lucrative growth opportunities.
• Innovations in antiviral formulations and combination therapies may redefine market dynamics.
• Major players include GSK, Teva, Mylan, and Sun Pharma, each with varying strategic focus.

This report synthesizes market data, competitive positioning, regulatory policies, and forecast models to inform stakeholder decision-making.

---

What are the current market dynamics for acyclovir?

Global Market Size and Growth Trends

Parameter	Details
Market Value (2022)	USD 1.2 billion
CAGR (2023–2028)	3.0–4.0%
Regional Distribution	North America (40%), Europe (25%), APAC (20%), ROW (15%)

Source: Grand View Research, 2022

Key Drivers

Factor	Impact
Increasing Herpesvirus Incidence	Herpes labialis, genital herpes, and shingles are prevalent globally, driving demand.
Aging Population	Older demographics exhibit higher infection rates, especially VZV.
Expanding Healthcare Access	Improved diagnostics and acceptance in emerging markets broaden utilization.
Generic Market Penetration	Patent expirations have increased affordability and access, expanding volumes.
Healthcare Spending Growth	Increased healthcare budgets enable broader antiviral prescriptions.

Major Market Challenges

Barrier	Implication
Patent Expirations	Accelerates generic competition, exerting downward pressure on prices.
Emergence of Resistance	Viral resistance reduces efficacy, necessitating new formulations.
Competition from Novel Antivirals	Drugs like valacyclovir and famciclovir pose substitutes.
Regulatory Hurdles	Variability in approvals across regions may delay entry or expansion.

Competitive Landscape

Company	Market Share (Estimate, 2022)	Key Strategies
GSK (Acyclovir Original)	35%	Maintaining brand dominance via established efficacy.
Teva Pharmaceuticals	20%	Focus on generics and biosimilars.
Mylan (Now part of Viatris)	15%	Price competitiveness and product diversification.
Sun Pharma	10%	Expanding regional presence, especially in APAC.
Others	20%	Independent generics, regional players.

---

What factors influence the financial trajectory of acyclovir?

Patent and Exclusivity Landscape

Timeline	Details
Original Patent Expiry (US)	2006
International Patent Status	Varies by country; many patents expired or are nearing expiration.
Impact on Revenue	Significant decline post-patent expiry; increased generics entry.

Pricing Dynamics

Pre- and Post-Patent Expiry	Impact
Pre-expiry	Higher margins via patent protection.
Post-expiry	Price erosion due to generic competition, volume-driven revenue focus.

Regional Revenue Contributions

Region	2022 Share	Growth Drivers
North America	40%	High healthcare expenditure, established infrastructure.
Europe	25%	Prescriptive norms, aging populations.
Asia-Pacific	20%	Rapid market expansion, increasing infection rates, affordability.
Rest of World	15%	Growing awareness and local manufacturing.

Emerging Opportunities

Market Segment	Potential Impact
Pediatric & Geriatric Use	Growing age groups with higher infection risk.
Chronic HSV Management	Shift toward long-term suppressive therapies.
Combination Therapies	Synergy with immunomodulatory agents to mitigate resistance.
Biosimilar Market Entry	Cost-effective alternatives, especially in price-sensitive markets.

---

How do regional and regulatory policies shape the trajectory?

Regulatory Policies Overview

• US FDA: Approves generic formulations post-patent expiration; encourages biosimilar development.
• EMA (Europe): Follows similar pathways; incentivizes generic entry with accelerated review pipelines.
• Asia-Pacific: Regulatory frameworks vary; some countries lack generic approval pathways, influencing market access.

Policy Impact Analysis

Policy Element	Effect on Market
Patent Laws and Exclusivity	Dictate timing of generic entry; influence revenue peaks.
Healthcare Reimbursement Policies	Determine affordability and prescribing patterns.
Quality and Manufacturing Standards	Affect market entry barriers for generics and biosimilars.

Trends & Future Outlook

• Increased focus on biosimilar registration procedures.
• Potential for bilateral or regional patent litigations delaying generic competition.
• Harmonization efforts could accelerate market entry and reduce disparities.

---

Comparative Analysis: Acyclovir versus Valacyclovir and Famciclovir

Parameter	Acyclovir	Valacyclovir	Famciclovir
Formulations	Oral, topical, intravenous	Oral	Oral
Bioavailability	10–20%	55–70%	75–77%
Dosing Frequency	Multiple daily doses	Once or twice daily	Twice daily
Cost	Lower (generics widely available)	Higher	Similar or higher than acyclovir
Efficacy	Established, for initial and recurrent infections	Similar, with better bioavailability	Similar, with improved convenience

Implication: While acyclovir remains cost-effective, newer agents like valacyclovir offer convenience, influencing prescribing preferences especially in developed markets.

---

Future Market Outlook and Innovation Trajectories

Technological and Pharmacological Innovations

• Prodrug Development: Enhanced formulations for better bioavailability and patient compliance.
• Combination Therapies: Synergistic agents targeting resistance mechanisms.
• Nanotechnology: Targeted delivery systems reducing adverse effects.
• Gene-Based Therapies: Potential future shift towards curative approaches over antiviral suppression.

Market Expansion Opportunities

Region	Drivers for Growth
Asia-Pacific	Population growth, rising healthcare expenditure, urbanization.
Latin America	Increasing access to healthcare, regional manufacturing hubs.
Africa	Growing prevalence of herpes infections, expanding clinics.

Potential Disruption Factors

• Transition towards personalized medicine.
• Regulatory barriers to novel delivery systems.
• Cost pressures limiting innovation investments.

---

Key Takeaways

• Acyclovir's market remains stable due to its longstanding efficacy, but faces margin compression post-patent expiry.
• Generics significantly influence pricing, expanding access but reducing overall revenue for brand holders.
• Rising herpesvirus prevalence and aging demographics drive demand growth, especially in emerging regions.
• Competition from newer antivirals and resistance patterns necessitate ongoing innovation.
• Regulatory frameworks and regional policies are critical determinants in market accessibility.
• Future growth hinges on technological innovation, regional market expansion, and strategic partnerships.

---

FAQs

1. What is the primary driver for the current growth of acyclovir?
The primary driver is the increasing global prevalence of herpesvirus infections, coupled with aging populations and expanding healthcare access, especially in emerging markets.

2. How do patent expirations impact acyclovir’s market?
Patent expirations lead to increased generic competition, lowering prices, and expanding volume-driven sales, but also reduce profit margins for originator companies.

3. Which regions are expected to see the fastest growth in acyclovir markets?
Asia-Pacific and Latin America are anticipated to experience the fastest growth owing to demographic shifts, improving healthcare infrastructure, and higher infection rates.

4. How is resistance affecting acyclovir's future?
Viral resistance, especially among immunocompromised patients, compels the development of new formulations and combination therapies to maintain efficacy.

5. What innovative developments could reshape the acyclovir market?
Prodrug formulations with improved bioavailability, combination therapies targeting resistance, and gene editing approaches represent key future innovations.

---

References

[1] Grand View Research. "Herpesvirus Treatments Market Size, Share & Trends Analysis." 2022.
[2] U.S. Food and Drug Administration. "Acyclovir Drug Approvals & Patent Status." 2022.
[3] European Medicines Agency. "Antiviral Drugs Regulatory Framework." 2022.
[4] MarketWatch. "Global Acyclovir Market Forecast and Trends." 2023.
[5] World Health Organization. "Herpes Simplex Virus Epidemiology." 2021.