PENCICLOVIR - Generic Drug Details

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

Penciclovir is the generic ingredient in two branded drugs marketed by Mylan, Padagis Israel, Teva Pharms Usa, and Torrent, and is included in four NDAs. Additional information is available in the individual branded drug profile pages.

There are three drug master file entries for penciclovir. Four suppliers are listed for this compound.

Summary for PENCICLOVIR

US Patents:	0
Tradenames:	2
Applicants:	4
NDAs:	4
Drug Master File Entries:	3
Finished Product Suppliers / Packagers:	4
Raw Ingredient (Bulk) Api Vendors:	109
Clinical Trials:	3
Patent Applications:	5,779
Drug Prices:	Drug price trends for PENCICLOVIR
What excipients (inactive ingredients) are in PENCICLOVIR?	PENCICLOVIR excipients list
DailyMed Link:	PENCICLOVIR at DailyMed

See drug prices for PENCICLOVIR

Recent Clinical Trials for PENCICLOVIR

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

Sponsor	Phase
Squarex, LLC	Phase 2
EMS	Phase 3
Novartis	Phase 4

See all PENCICLOVIR clinical trials

Pharmacology for PENCICLOVIR

Drug Class	Herpesvirus Nucleoside Analog DNA Polymerase Inhibitor
Mechanism of Action	DNA Polymerase Inhibitors

Anatomical Therapeutic Chemical (ATC) Classes for PENCICLOVIR

D06BB	Antivirals
D06B	CHEMOTHERAPEUTICS FOR TOPICAL USE
D06	ANTIBIOTICS AND CHEMOTHERAPEUTICS FOR DERMATOLOGICAL USE
D	Dermatologicals

J05AB	Nucleosides and nucleotides excl. reverse transcriptase inhibitors
J05A	DIRECT ACTING ANTIVIRALS
J05	ANTIVIRALS FOR SYSTEMIC USE
J	Antiinfectives for systemic use

US Patents and Regulatory Information for PENCICLOVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Torrent	PENCICLOVIR	penciclovir	CREAM;TOPICAL	216981-001	Aug 7, 2023	AB	RX	No	No
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	AB	RX	Yes	Yes
Teva Pharms Usa	PENCICLOVIR	penciclovir	CREAM;TOPICAL	212710-001	Nov 9, 2022	AB	RX	No	No

Expired US Patents for PENCICLOVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	6,124,304
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	5,075,445
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	6,573,378

PENCICLOVIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Penciclovir

Introduction

Penciclovir, a synthetic acyclic guanine derivative, is a crucial antiviral drug used primarily for the treatment of herpes simplex virus (HSV) infections, particularly herpes labialis (cold sores). Here, we delve into the market dynamics and financial trajectory of penciclovir, highlighting its current status, growth drivers, and future projections.

Market Size and Growth

The global cold sore treatment market, in which penciclovir is a key player, is anticipated to grow significantly. By 2031, the market is expected to reach $1.57 billion, up from $1.02 billion in 2024, at a Compound Annual Growth Rate (CAGR) of 6.3%[1].

Growth Drivers

Several factors are driving the growth of the penciclovir market:

Increasing Incidence of Herpes Labialis

The rising incidence of herpes labialis infections globally is a major driver. According to the World Health Organization (WHO), approximately 3.7 billion people under the age of 50 have HSV-1 infection, which is the primary cause of cold sores[1].

Growing Demand for Over-the-Counter Medications

There is an increasing adoption of over-the-counter (OTC) medications for cold sores, which includes topical antiviral drugs like penciclovir. This shift towards OTC treatments is driven by consumer convenience and the desire for quick relief from symptoms[1].

Advancements in Formulations

The market is witnessing numerous product launches with various formulations, dosages, and application methods. For instance, long-acting formulations of penciclovir cream are being developed to enhance treatment efficacy and patient compliance[1].

Market Segments

Product Type

The topical treatment segment, which includes penciclovir creams and ointments, accounts for the largest market share. This is due to the advantages of topical treatments, such as immediate relief and localized action. Penciclovir creams, in particular, are widely used because of their effectiveness in reducing healing time when applied at the first signs of a cold sore outbreak[1].

Cold Sore Type

Primary outbreaks of herpes labialis, which affect most adults by the age of 20, dominate the market. Children and adolescents are highly susceptible to primary HSV-1 infections, making this segment significant for penciclovir sales[1].

Age Group

Children form the largest age group for penciclovir treatment due to their underdeveloped immune defenses. The safety profiles of treatments targeting children are continuously improving to prevent serious complications[1].

Distribution Channel

Hospital pharmacies hold a dominant position in the distribution of penciclovir, primarily due to the availability of prescription-only medications and the need for regular check-ups[1].

Mechanism of Action and Efficacy

Penciclovir works by inhibiting viral DNA polymerase, thereby preventing the replication of HSV within infected cells. Its intracellular half-life is significantly longer than that of acyclovir, making it more effective in treating herpes labialis. Penciclovir is phosphorylated by viral thymidine kinase and then converted to its triphosphate form, which selectively inhibits viral DNA polymerase[5].

Competitive Landscape

The market for antiviral drugs, including penciclovir, is competitive with several key players. Penciclovir, marketed under the brand name Denavir, competes with other antiviral drugs like acyclovir and valacyclovir. However, its longer intracellular half-life and lower toxicity give it a competitive edge in the treatment of herpes labialis[5].

Financial Projections

Given the growing demand for cold sore treatments and the specific advantages of penciclovir, the financial trajectory for this drug is positive. Here are some key financial projections:

Revenue Growth

The cold sore treatment market, driven by increasing awareness and the rising incidence of HSV-1 infections, is expected to grow steadily. Penciclovir, being a key player in this market, will likely see significant revenue growth over the forecast period of 2024-2031[1].

Market Share

The topical treatment segment, which includes penciclovir, is expected to maintain its dominant position due to its immediate relief and localized action. This will ensure a substantial market share for penciclovir in the cold sore treatment market[1].

Challenges and Restraints

Despite the positive growth trajectory, there are some challenges that could impact the market:

Social Stigma

The social stigma associated with cold sores can hinder market growth as some patients may avoid seeking treatment due to embarrassment or fear of social judgment[1].

Self-Limiting Nature of Outbreaks

Cold sores are often self-limiting, meaning they can resolve on their own without treatment. This can reduce the demand for antiviral medications like penciclovir[1].

Lack of Awareness

In low and middle-income countries, there is a lack of awareness about the symptoms and treatment options for cold sores, which can limit market growth in these regions[1].

Research and Development

The market is expected to gain traction from increasing research and development activities aimed at developing novel drug formulations. For example, long-acting formulations of penciclovir cream are being evaluated for their efficacy and safety in treating herpes labialis. Such innovations will further support the growth of the penciclovir market[1].

Key Takeaways

• Market Growth: The cold sore treatment market, including penciclovir, is expected to grow at a CAGR of 6.3% from 2024 to 2031.
• Dominant Segment: Topical treatments, particularly penciclovir creams, will continue to dominate the market due to their immediate relief and localized action.
• Primary Outbreaks: Primary outbreaks of herpes labialis will remain a significant segment due to the large patient population affected.
• Age Group: Children will continue to be a major age group for penciclovir treatment due to their underdeveloped immune defenses.
• Distribution Channel: Hospital pharmacies will remain a dominant distribution channel due to the availability of prescription-only medications.

FAQs

What is the primary mechanism of action of penciclovir?

Penciclovir works by inhibiting viral DNA polymerase, preventing the replication of HSV within infected cells. It is phosphorylated by viral thymidine kinase and then converted to its triphosphate form, which selectively inhibits viral DNA polymerase[5].

Which segment dominates the cold sore treatment market?

The topical treatment segment, which includes penciclovir creams and ointments, dominates the cold sore treatment market due to its immediate relief and localized action[1].

What are the key growth drivers for the penciclovir market?

The key growth drivers include the rising incidence of herpes labialis infections, growing demand for over-the-counter medications, and advancements in formulations such as long-acting penciclovir creams[1].

What challenges might impact the penciclovir market?

Challenges include the social stigma associated with cold sores, the self-limiting nature of outbreaks, and a lack of awareness about symptoms and treatment options in low and middle-income countries[1].

How is the competitive landscape for penciclovir?

Penciclovir competes with other antiviral drugs like acyclovir and valacyclovir but has a competitive edge due to its longer intracellular half-life and lower toxicity[5].

Sources

1. GlobeNewswire: Cold Sore Treatment Market Size to Reach $1.57 Billion by 2031 Globally at a 6.3% CAGR - Report by Coherent Market Insights.
2. PubMed: Prolonged prophylaxis with valganciclovir is cost effective...
3. MDPI: Drug Discovery of Nucleos(t)ide Antiviral Agents: Dedicated to Prof...
4. Wicz: Penciclovir Market Size 2024 Analysis by Top Key Players, Industry...
5. DrugBank: Penciclovir: Uses, Interactions, Mechanism of Action - DrugBank.