POLIDOCANOL - Generic Drug Details

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

Polidocanol is the generic ingredient in two branded drugs marketed by Chemisch Fbrk Krsslr and Provensis, and is included in two NDAs. There are four patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Polidocanol has ninety-seven patent family members in thirty countries.

Two suppliers are listed for this compound.

Summary for POLIDOCANOL

International Patents:	97
US Patents:	4
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	26
Patent Applications:	4,557
What excipients (inactive ingredients) are in POLIDOCANOL?	POLIDOCANOL excipients list
DailyMed Link:	POLIDOCANOL at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for POLIDOCANOL

Dosage:

SOLUTION;INTRAVENOUS

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for POLIDOCANOL

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

Sponsor	Phase
Assiut University	Phase 4
Massachusetts General Hospital	Phase 1
Johns Hopkins University	Phase 1

See all POLIDOCANOL clinical trials

Pharmacology for POLIDOCANOL

Drug Class	Sclerosing Agent
Mechanism of Action	Sclerosing Activity
Physiological Effect	Vascular Sclerosing Activity

Anatomical Therapeutic Chemical (ATC) Classes for POLIDOCANOL

C05BB	Sclerosing agents for local injection
C05B	ANTIVARICOSE THERAPY
C05	VASOPROTECTIVES
C	Cardiovascular system

US Patents and Regulatory Information for POLIDOCANOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013		RX	Yes	Yes			Y	Y
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013		RX	Yes	Yes			Y
Chemisch Fbrk Krsslr	ASCLERA	polidocanol	SOLUTION;INTRAVENOUS	021201-001	Mar 30, 2010		RX	Yes	No
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013		RX	Yes	Yes			Y

Expired US Patents for POLIDOCANOL

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013

International Patents for POLIDOCANOL

Country	Patent Number	Title	Estimated Expiration
China	1882311	Methods of preparing a foam comprising a sclerosing agent
Japan	2007504872
Canada	2538172	APPAREIL ET PROCEDE POUR DISTRIBUER DE LA MOUSSE (APPARATUS AND METHOD FOR DISPENSING FOAM)
Portugal	1701701

POLIDOCANOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Polidocanol

Introduction

Polidocanol, a sclerosing agent, has been widely used in the treatment of varicose veins, spider veins, and other vascular conditions. Here, we delve into the market dynamics and financial trajectory of polidocanol, highlighting its current status, growth drivers, and future prospects.

Market Demand and Growth Drivers

The demand for polidocanol is driven by several key factors:

Growing Prevalence of Venous Diseases

The increasing prevalence of venous diseases, particularly among the aging population, is a significant driver of the polidocanol market. As the global population ages, the incidence of varicose and spider veins is expected to rise, thereby boosting the demand for effective treatments like polidocanol[4].

Enhanced Aesthetic Awareness

There is a growing awareness and desire for aesthetic treatments, which includes the removal of unsightly varicose and spider veins. This trend is particularly strong in developed countries where cosmetic procedures are more common and accepted[4].

Increasing Geriatric Population

The geriatric population is more prone to venous diseases due to decreased mobility and other age-related factors. As this demographic segment grows, so does the demand for polidocanol and other sclerosing agents[4].

Market Segmentation

The polidocanol market can be segmented based on several criteria:

Type of Veins Treated

The market is categorized by the diameter of the veins treated, including veins less than 1 mm, between 1 to 3 mm, and more than 3 mm in diameter. Each category has different treatment requirements and market dynamics[5].

Application Settings

Polidocanol is used in various settings, including hospitals, beauty salons, and other healthcare facilities. The market demand varies significantly across these different application settings[5].

Geographical Regions

The market is also segmented geographically, with regions such as North America, Europe, Asia-Pacific, South America, and the Middle East and Africa. Each region has its own market size and growth prospects[5].

Clinical Efficacy and Safety

Polidocanol has demonstrated strong clinical efficacy and safety profiles in various studies:

Varicose Veins Treatment

Polidocanol has shown significant improvement in symptoms associated with varicose veins, such as heaviness, achiness, swelling, throbbing, and itching. It has also been compared favorably to other sclerosing agents like sodium tetradecyl sulfate (STS) in terms of fewer side effects like injection site discoloration, neovascularization, and scarring[1].

Tendinopathies

Polidocanol has been studied for its potential in treating tendinopathies, including Achilles and patellar tendinopathy. While some studies show promising results, larger randomized controlled trials are needed to confirm its efficacy in these conditions[1].

Venous and Arteriovenous Malformations

Polidocanol sclerotherapy has been effective in treating venous malformations, with a significant number of patients achieving symptom relief and malformation reduction. However, more robust clinical evidence is required to fully establish its role in this area[1].

Market Size and Forecast

The global polidocanol market is anticipated to experience strong growth rates in the coming years:

Current Market Size

The market size of polidocanol is substantial and growing, driven by the increasing demand for sclerotherapy treatments. The exact figures vary by region and application, but the overall trend is positive[5].

Future Projections

Market research indicates that the polidocanol foam sclerosant market will continue to expand, with forecasts suggesting significant growth through 2031. This growth is attributed to the rising prevalence of venous diseases, enhanced aesthetic awareness, and the increasing geriatric population[5].

Financial Trajectory

Revenue Growth

The revenue generated from polidocanol sales is expected to increase steadily over the next few years. This growth is driven by the expanding market demand and the introduction of new products and formulations, such as foam sclerosants[5].

Key Players and Investments

Companies like Boston Scientific, which has investments in vascular disease treatments, are likely to benefit from the growing demand for polidocanol. Boston Scientific's acquisition of a majority stake in Acotec, a leader in innovative vascular solutions, further strengthens its position in this market[2].

Challenges and Opportunities

Regulatory Environment

The regulatory environment plays a crucial role in the market dynamics of polidocanol. Approval from regulatory bodies such as the FDA is essential for the introduction of new formulations and indications. For instance, Varithena™, a polidocanol foam sclerosant, has received FDA approval, which has helped in expanding its market reach[2].

Competitive Landscape

The market for sclerosing agents is competitive, with several products available. However, polidocanol's favorable safety and efficacy profile positions it as a leading option. The entry of new players and the development of new formulations will continue to shape the competitive landscape[1].

Key Takeaways

• Growing Demand: The market for polidocanol is driven by the increasing prevalence of venous diseases and enhanced aesthetic awareness.
• Clinical Efficacy: Polidocanol has demonstrated strong clinical efficacy and safety in treating varicose veins and other vascular conditions.
• Market Segmentation: The market is segmented by vein diameter, application settings, and geographical regions.
• Financial Growth: The revenue from polidocanol sales is expected to grow significantly through 2031.
• Regulatory and Competitive Environment: Regulatory approvals and competitive dynamics will continue to influence the market trajectory.

FAQs

What is polidocanol used for?

Polidocanol is used for the treatment of varicose veins, spider veins, and other vascular conditions. It is also being studied for its potential in treating tendinopathies and venous malformations.

What are the key drivers of the polidocanol market?

The key drivers include the growing prevalence of venous diseases, enhanced aesthetic awareness, and the increasing geriatric population.

How does polidocanol compare to other sclerosing agents?

Polidocanol has been shown to have fewer side effects compared to other sclerosing agents like sodium tetradecyl sulfate (STS), making it a preferred option for many patients.

What is the current market size and forecast for polidocanol?

The current market size is substantial, and forecasts indicate significant growth through 2031, driven by increasing demand and expanding applications.

Which companies are key players in the polidocanol market?

Companies like Boston Scientific, with its investments in vascular disease treatments, are key players in the polidocanol market.

What are the challenges facing the polidocanol market?

The market faces challenges such as regulatory approvals, competitive dynamics, and the need for larger clinical trials to establish efficacy in certain indications.

Sources

1. VA Pharmacy Benefits Management Services, Medical Advisory Panel, and VISN Pharmacist Executives. Polidocanol (Asclera® and Varithena®) National Drug Monograph May 2014.
2. Boston Scientific. 2022 Annual Report.
3. Fierce Biotech. A look at the R&D landscape in obesity, led by GLP-1s.
4. 360iResearch. Polidocanol Injection Market Size & Share 2025-2030.
5. MarketResearchIntellect. Global Polidocanol Foam Sclerosant Market.