DENAVIR Drug Patent Profile

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

Denavir is a drug marketed by Mylan and is included in one NDA.

The generic ingredient in DENAVIR is penciclovir. There are three drug master file entries for this compound. Four suppliers are listed for this compound. Additional details are available on the penciclovir profile page.

DrugPatentWatch^® Litigation and Generic Entry Outlook for Denavir

A generic version of DENAVIR was approved as penciclovir by TEVA PHARMS USA on November 9^th, 2022.

Summary for DENAVIR

US Patents:	0
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	110
Clinical Trials:	1
Patent Applications:	4,952
Drug Prices:	Drug price information for DENAVIR
What excipients (inactive ingredients) are in DENAVIR?	DENAVIR excipients list
DailyMed Link:	DENAVIR at DailyMed

See drug prices for DENAVIR

Recent Clinical Trials for DENAVIR

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

Sponsor	Phase
Squarex, LLC	Phase 2

See all DENAVIR clinical trials

Pharmacology for DENAVIR

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

US Patents and Regulatory Information for DENAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996	AB	RX	Yes	Yes

Expired US Patents for DENAVIR

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996
Mylan	DENAVIR	penciclovir	CREAM;TOPICAL	020629-001	Sep 24, 1996

International Patents for DENAVIR

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

Country	Patent Number	Title	Estimated Expiration
South Africa	9510482
Czech Republic	283721	Purinové deriváty a jejich farmaceutické použití (2-AMINO-9-/4-ACETOXY-3-ACETOXYMETHYLBUT-1-YL/PURINE ITS USE FOR PREPARING PHARMACEUTICAL PREPARATIONS AND THE PHARMACEUTICAL PREPARATIONS CONTAINING THEREOF)
Cyprus	2375	Use of penciclorin for the treatment of post-therapeutic neuralgia.
Hungary	215842	Penciklovir hatóanyagot tartalmazó helyi alkalmazású gyógyászati készítmények és eljárás előállításukra (TOPICAL PHARMACEUTICAL FORMULATIONS CONTAINING PENCICLOVIR AND PROCESS FOR PRODUCING THEM)
Spain	2166834
Norway	874764
Mexico	160431	UN PROCEDIMIENTO PARA PREPARAR DERIVADOS DE LA GUANINA

Supplementary Protection Certificates for DENAVIR

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0296560	98C0015	Belgium		PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: NL 21 303 19980415; FIRST REGISTRATION: GB - 10592/0078 19960228
0141927	SPC/GB96/014	United Kingdom		SPC/GB96/014: 20040810, EXPIRES: 20090809
0182024	SPC/GB94/002	United Kingdom		SPC/GB94/002: 20050910, EXPIRES: 20081209
0141927	97C0033	Belgium		PRODUCT NAME: PENCICLOVIR; NAT. REGISTRATION NO/DATE: 981 IS 110 F 7; 19970206; FIRST REGISTRATION: GB 10592/0078 19960228

DENAVIR Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for DENAVIR

Introduction to DENAVIR

DENAVIR, also known as penciclovir, is a topical antiviral drug primarily used for the treatment of cold sores (herpes labialis). It belongs to the class of topical antivirals and is applied directly to the affected area to inhibit the replication of the herpes simplex virus.

Market Positioning

Drug Class and Usage

DENAVIR is classified as a topical antiviral, which sets it apart from systemic antivirals like valacyclovir and Valtrex. Its topical application makes it a preferred choice for patients seeking to avoid oral medications or injections[2][4].

Competitive Landscape

In the antiviral market, DENAVIR competes with other topical and systemic antivirals. However, its unique application method and targeted efficacy against herpes labialis give it a niche market position. Key competitors include valacyclovir (Valtrex) and other topical antivirals, but DENAVIR's high user satisfaction rate (9.1 out of 10) indicates strong consumer preference[5].

Financial Trajectory

Current Pricing and Costs

The cost of DENAVIR 1% topical cream is significant, with a supply of 5 grams costing around $865 for cash-paying customers. However, generic versions and patient assistance programs can reduce this cost. For example, a generic version of penciclovir topical cream can cost as low as $754.08 for 5 grams[2].

Revenue Contribution

While specific revenue figures for DENAVIR are not provided, it is part of the broader antiviral drugs market, which is projected to grow at a CAGR of 3.9% from 2023 to 2033. The global antiviral drugs market is expected to reach USD 89.68 billion by 2033, up from USD 61.42 billion in 2023[1].

Market Drivers and Challenges

Increasing Demand for Topical Treatments

The preference for non-invasive therapeutic solutions is on the rise, driving the demand for topical drug delivery systems. This trend is expected to boost the market for DENAVIR, as patients increasingly opt for creams and gels over oral or injectable medications[3].

Prevalence of Viral Infections

The high prevalence of viral infections such as herpes labialis continues to drive the demand for antiviral drugs. According to market reports, the rising incidence of such infections, particularly in emerging economies, is a significant driver for the antiviral market[1].

Generic Competition and Pricing Pressure

The availability of generic versions of DENAVIR can impact its market share and pricing. Generic penciclovir topical cream is significantly cheaper, which could attract price-sensitive consumers. Additionally, patient assistance programs and discount cards can further reduce the cost, making the drug more accessible but potentially affecting the revenue of the branded version[2].

Regional Market Dynamics

North America and Europe

North America, particularly the United States, holds a significant share of the antiviral drugs market, including DENAVIR. This region is expected to maintain its dominance due to advanced healthcare infrastructure and high awareness of antiviral treatments[1].

Asia Pacific

The Asia Pacific region is anticipated to witness the fastest growth in the antiviral drugs market, driven by the rising prevalence of viral infections, improving healthcare infrastructure, and growing awareness about infectious diseases. This growth could also benefit DENAVIR, especially in countries like India and China where generic manufacturing is prevalent[1].

Regulatory and Developmental Aspects

Regulatory Environment

The regulatory landscape for antiviral drugs, including DENAVIR, is stringent but supportive of innovation. Recent developments and approvals, such as the Joint Procurement Agreement for sotrovimab in the EU, indicate a favorable regulatory environment that can support market growth[1].

Clinical Studies and Efficacy

DENAVIR has been studied in several clinical trials, demonstrating its efficacy in reducing the duration of cold sore lesions. These studies have shown that DENAVIR can shorten the mean duration of lesions by approximately half a day compared to placebo[4].

Key Takeaways

• Market Growth: The antiviral drugs market, including DENAVIR, is expected to grow at a CAGR of 3.9% from 2023 to 2033.
• Pricing and Generics: The high cost of DENAVIR can be mitigated by generic versions and patient assistance programs.
• Regional Dynamics: North America is a key market, but the Asia Pacific region is expected to grow rapidly.
• Regulatory Support: A favorable regulatory environment supports the development and approval of antiviral drugs.
• Consumer Preference: DENAVIR enjoys high user satisfaction rates, indicating strong consumer preference.

FAQs

1. What is DENAVIR used for? DENAVIR (penciclovir) is used for the treatment of cold sores (herpes labialis).

2. How much does DENAVIR cost? The cost of DENAVIR 1% topical cream is around $865 for a 5-gram supply, but generic versions can be significantly cheaper.

3. Is DENAVIR available in generic form? Yes, a generic version of penciclovir topical cream is available, which can be more cost-effective.

4. What are the side effects of DENAVIR? Common side effects include application site reactions, hypesthesia/local anesthesia, and taste perversion. Serious side effects are rare but can include headache, oral/pharyngeal edema, and parosmia[4].

5. How does DENAVIR compare to other antiviral drugs? DENAVIR is a topical antiviral with high user satisfaction, competing with systemic antivirals like valacyclovir (Valtrex). It is preferred for its targeted efficacy against herpes labialis and non-invasive application method[5].

Cited Sources

1. Future Market Insights: Anti-Viral Drugs Market Share, Trend & Outlook by 2033.
2. Drugs.com: Denavir Prices, Coupons, Copay Cards & Patient Assistance.
3. Verified Market Research: Topical Drug Delivery Market is expected to generate a revenue of USD 177.97 Billion by 2031.
4. FDA: DENAVIR® (penciclovir) Cream, for topical administration.
5. Drugs.com: Denavir Alternatives Compared.