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 two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Polidocanol has thirty-one patent family members in eighteen countries.

Two suppliers are listed for this compound.

Summary for POLIDOCANOL

International Patents:	31
US Patents:	2
Tradenames:	2
Applicants:	2
NDAs:	2
Finished Product Suppliers / Packagers:	2
Raw Ingredient (Bulk) Api Vendors:	76
Clinical Trials:	28
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
Sohag University	NA
Assiut University	NA
Assiut University	Phase 4

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
Chemisch Fbrk Krsslr	ASCLERA	polidocanol	SOLUTION;INTRAVENOUS	021201-001	Mar 30, 2010		RX	Yes	No
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-002	Dec 21, 2017		DISCN	Yes	No
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013		RX	Yes	Yes			Y
Chemisch Fbrk Krsslr	ASCLERA	polidocanol	SOLUTION;INTRAVENOUS	021201-002	Mar 30, 2010		RX	Yes	Yes
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
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013

International Patents for POLIDOCANOL

Country	Patent Number	Title	Estimated Expiration
Denmark	1673293
Poland	1673293
Cyprus	1111096
Russian Federation	2006111474	УСТРОЙСТВО И СПОСОБ ВЫДАЧИ ПЕНЫ
Austria	486023

Market Dynamics and Financial Trajectory for Polidocanol in the Pharmaceutical Sector

Last updated: July 28, 2025

Introduction

Polidocanol, known chemically as lauromacrogol 400, is a sclerosing agent primarily utilized for treating varicose veins and telangiectasias. Its unique properties and established efficacy make it a notable asset within vascular and dermatological therapies. This analysis examines the current market dynamics, growth drivers, challenges, and future financial prospects for polidocanol, providing insights essential for stakeholders contemplating investment or strategic positioning in this niche.

Market Overview

The global market for polidocanol is embedded within the broader sclerosis and dermatology segments, with an estimated valuation of approximately USD 200 million as of 2022, and projected CAGR of 6-8% over the next five years. This growth is driven by increasing prevalence of chronic venous diseases, expanding minimally invasive treatment techniques, and rising demand for outpatient procedures.

Therapeutic Applications and Regulatory Landscape

Polidocanol’s primary indication revolves around sclerotherapy in phlebology. Its attributes include low toxicity, minimal allergic reactions, and ease of administration, enabling outpatient procedures with minimal discomfort. Regulatory agencies such as the FDA, EMA, and respective health authorities in Asia ensure rigorous safety and efficacy standards. Market expansion hinges on continual regulatory validation and broader approval for diverse indications, which could unlock new revenue streams.

Key Market Drivers

1. Rising Burden of Chronic Venous Disorders:
   Global epidemiological data highlights a surge in chronic venous insufficiency (CVI) and varicose veins, particularly among aging populations. The World Federation of Vascular Surgeons estimates that up to 40% of adults suffer from varicose veins, spurring demand for effective sclerosing agents like polidocanol.

2. Advancement in Minimally Invasive Techniques:
   Percutaneous sclerotherapy procedures employing polidocanol are increasingly preferred over traditional surgical interventions due to reduced recovery times and lower complication rates. Technological progress enhances treatment efficacy, thus expanding market acceptance.

3. Preference for Outpatient and Office-based Procedures:
   Healthcare trends favor outpatient management of venous diseases, which boosts demand for sclerosing agents compatible with such settings. Polidocanol’s safety profile and ease of use position it favorably within this paradigm.

4. Growing Aesthetic and Dermatological Applications:
   Beyond venous treatment, polidocanol finds use in dermatology for telangiectasia, hemangiomas, and pigmented lesions, broadening its application base. Rising aesthetic consciousness and non-invasive treatment preferences propel this segment.

5. Market Expansion in Emerging Economies:
   Rapid urbanization and improved healthcare access in Asia-Pacific, Latin America, and Africa foster opportunities for significant market growth. Local manufacturing and regulatory approvals facilitate deployment in these regions.

Market Challenges

1. Competition from Alternative Agents:
   Sodium tetradecyl sulfate and foam sclerosants offer competition, with differences in efficacy, safety, and cost influencing clinical preference. Polidocanol’s slight edge in safety may not suffice to outpace rivals without targeted marketing.

2. Pricing and Reimbursement Constraints:
   Pricing strategies are critical, particularly in price-sensitive markets. Reimbursement policies impact adoption, especially in countries where healthcare budgets are constrained.

3. Regulatory Barriers and Approval Delays:
   While polidocanol enjoys approval in multiple jurisdictions, obtaining and maintaining regulatory clearance in emerging markets can be lengthy and resource-intensive.

4. Limited Diversification of Formulations:
   Concentration on liquid sclerosing formulations may confine growth. There is emerging interest in foam formulations, which exhibit enhanced efficacy but face regulatory and manufacturing hurdles.

Financial Trajectory and Investment Outlook

The financial outlook for polidocanol suggests stable growth fueled by macro trends in vein therapy and dermatology. Market players targeting diversification into foam formulations and expanding into new therapeutic indications are expected to gain competitive advantage, leading to increased revenues.

• Revenue Projections:
  Based on current trends, revenues could reach USD 300-350 million by 2028, assuming a 6-8% CAGR. Expansion into aesthetic markets and emerging economies could accelerate this trajectory.

• Profitability and R&D:
  Investment in research to optimize formulations, improve delivery systems, and obtain new indications will be essential. Companies that innovate can command premium pricing, enhance margins, and reinforce market share.

• Strategic Opportunities:
  Mergers and acquisitions of regional distributors or local producers can facilitate market penetration. Partnerships with aesthetic clinics and dermatology providers can diversify revenue streams.

Future Outlook

The future of polidocanol hinges on regulatory approvals, technological advancements, and expanding clinical evidence. Foam sclerotherapy, with proven superior efficacy, is poised to become a dominant application, potentially doubling market size. Integration with imaging-guided techniques and combination therapies may further augment its clinical utility.

Regulatory and Market Development Strategies

• Approvals in New Indications:
  Seeking approvals for varicocele, hemorrhoids, and cosmetic indications can broaden the revenue base.

• Formulation Innovations:
  Developing preservative-free, pre-filled syringes and foam variants to enhance safety and ease of use.

• Market Access and Education:
  Investing in clinician education campaigns can drive adoption, especially in regions with limited awareness.

Key Challenges and Mitigation Strategies

• Navigating diverse regulatory environments requires proactive engagement with health authorities.
• Managing pricing strategies and reimbursement negotiations to ensure market competitiveness.
• Conducting robust clinical trials to expand evidentiary support for off-label uses.

Key Takeaways

• The global polidocanol market is positioned for steady growth driven by rising venous disease prevalence and minimally invasive procedures.
• Innovation in formulations, expansion into aesthetic applications, and regulatory approvals will be pivotal for market expansion.
• Competition from alternative sclerosants necessitates differentiation through safety profiles, ease of use, and evidence-based benefits.
• Market entry in emerging economies offers substantial upside but demands tailored strategies considering local regulatory and economic factors.
• Continuous R&D, strategic partnerships, and clinician education are vital for long-term profitability.

Conclusion

Polidocanol’s established efficacy, favorable safety profile, and expanding clinical applications underpin a positive financial trajectory. Stakeholders capable of navigating regulatory landscapes, innovating within formulations, and strategically expanding into emerging markets are well-positioned to capitalize on its growth potential. As minimally invasive treatments and aesthetic demands increase globally, polidocanol remains a compelling asset within vascular and dermatological therapeutics.

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FAQs

1. What are the main therapeutic uses of polidocanol?
Polidocanol is primarily used for sclerotherapy in treating varicose veins, telangiectasias, hemangiomas, and for cosmetic vein reduction. It’s also explored for off-label indications such as hemorrhoids and varicocele treatment.

2. How does polidocanol compare with alternative sclerosants?
Polidocanol offers a superior safety profile with fewer allergic reactions and skin staining compared to agents like sodium tetradecyl sulfate. Its ease of administration and efficacy make it a preferred choice, though cost and regional preferences influence usage.

3. What are the growth prospects for polidocanol in emerging markets?
Growing healthcare infrastructure, increasing awareness, and the rise in venous disease prevalence make emerging markets attractive for polidocanol. Key to success is obtaining regulatory approvals and tailoring marketing strategies to local needs.

4. How is foam formulation impacting the market?
Foam polidocanol has demonstrated increased efficacy in occluding larger veins and reducing treatment sessions. The shift towards foam formulations is expected to accelerate market growth but requires regulatory clearances and manufacturing scale-up.

5. What are the major challenges facing polidocanol’s market expansion?
Competition from alternative agents, regulatory delays, pricing pressures, and limited formulations remain challenges. Overcoming these requires innovation, strategic regulatory engagement, and expanding clinical evidence.

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Sources

[1] Market Research Future, "Global Sclerotherapy Market," 2022.
[2] World Federation of Vascular Surgeons, "Epidemiology of Venous Disease," 2021.
[3] Business Insights, "Emerging Trends in Aesthetic Dermatology," 2022.
[4] Regulatory Agencies, "Polidocanol Approvals," 2023.
[5] Industry Reports, "Foam Sclerotherapy Market Analysis," 2022.