VARITHENA Drug Patent Profile

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

Varithena is a drug marketed by Provensis and is included in one NDA. There are two patents protecting this drug.

This drug has thirty-one patent family members in eighteen countries.

The generic ingredient in VARITHENA is polidocanol. Two suppliers are listed for this compound. Additional details are available on the polidocanol profile page.

DrugPatentWatch^® Generic Entry Outlook for Varithena

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 12, 2032. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for VARITHENA

International Patents:	31
US Patents:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	90
Clinical Trials:	5
Patent Applications:	5,693
Drug Prices:	Drug price information for VARITHENA
What excipients (inactive ingredients) are in VARITHENA?	VARITHENA excipients list
DailyMed Link:	VARITHENA at DailyMed

See drug prices for VARITHENA

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

NDA:

205098

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 VARITHENA

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

Sponsor	Phase
OhioHealth	Phase 4
BTG International Inc.	Phase 4
Boston Scientific Corporation	Phase 4

See all VARITHENA clinical trials

US Patents and Regulatory Information for VARITHENA

VARITHENA is protected by two US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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	205098-002	Dec 21, 2017		DISCN	Yes	No
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013		RX	Yes	Yes			Y
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013		RX	Yes	Yes			Y

Expired US Patents for VARITHENA

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
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013
Provensis	VARITHENA	polidocanol	SOLUTION;INTRAVENOUS	205098-001	Nov 25, 2013

International Patents for VARITHENA

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

Country	Patent Number	Title	Estimated Expiration
China	1882312	Methods of preparing a foam comprising a sclerosing agent
China	1878706	Apparatus and method for dispensing foam
Canada	2661728	GENERATION DE MICROMOUSSE THERAPEUTIQUE (GENERATION OF THERAPEUTIC MICROFOAM)
Canada	2376229
World Intellectual Property Organization (WIPO)	0077146
Japan	2007511591
Canada	2373939	GENERATION DE MICROMOUSSE THERAPEUTIQUE (GENERATION OF THERAPEUTIC MICROFOAM)

Market Dynamics and Financial Trajectory for VARITHENA

Last updated: December 26, 2025

Executive Summary

VARITHENA (polidocanol injectable foam) is a minimally invasive treatment for superficial varicose veins, approved by the FDA in 2013. The global phlebology market, driven by rising varicose vein prevalence, technological advances, and expanding minimally invasive procedures, positions VARITHENA as a significant product. This report analyzes the market environment, competitive landscape, revenue projections, regulatory factors, and future growth prospects to inform strategic decisions for stakeholders.

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Introduction

VARITHENA, developed by BTG International (a Boston Scientific subsidiary), offers a non-surgical solution for patients with symptomatic saphenous vein reflux. The product utilizes foam sclerotherapy technology, which enhances treatment efficacy and reduces recovery times.

This analysis dissects the key market drivers, financial trends, competitive pressures, and regulatory impacts shaping VARITHENA’s commercial journey.

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Market Overview

Parameter	Value	Notes
Global varicose vein treatment market size (2022)	USD 1.1 billion	Estimated, growing at 7-8% CAGR (2022–2027)
Number of treated patients annually**	Approx. 3.5 million	US accounts for about 40%, Europe 35%
Revenue from foam sclerotherapy products	USD 350 million	Approximately 32% of the market
Estimated share of VARITHENA in foam segment	~20-25%	As per recent market research reports

Sources:
European Vascular Society statistics, GlobalData estimates, Industry reports (Ref. [1], [2])

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Key Market Drivers

1. Rising Prevalence of Varicose Veins and Chronic Venous Disease (CVD)

• An estimated 30 million adults in the US suffer from varicose veins, with prevalence increasing with age, obesity, and sedentary lifestyles[3].
• The global burden is projected to increase by 2.8% annually, influenced by aging populations.

2. Shift Toward Minimally Invasive Interventions

• Growing preference among patients and physicians for procedures like foam sclerotherapy, endovenous laser ablation (EVLA), and radiofrequency ablation (RFA).
• VARITHENA's efficacy, safety, and minimal downtime are major attractions.

3. Evolving Regulatory and Reimbursement Policies

• Favorable coding and reimbursement policies in the US (CPT codes for foam sclerotherapy established in 2012) facilitate adoption.
• European guidelines favor minimally invasive treatments, increasing procedural volumes.

4. Technological Innovations and Differentiation

• VARITHENA’s proprietary foam formulation provides better vein occlusion rates and reduced adverse events.
• Ongoing R&D aims to optimize formulations for broader indications.

5. Expansion into Emerging Markets

• Growing healthcare infrastructure in Asia-Pacific (e.g., China, India) and Latin America opens new revenue streams.

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Competitive Landscape

Company	Product(s)	Market Share (Foam Segment, 2022)	Notable Features
BTG/Boston Scientific	VARITHENA	~20-25%	Proprietary foam formulation, strong clinical data
AngioDynamics	Varithena (under license)	Competitive	Alternative foam agents
Cetec Medical	Sotradecol foam	Emerging	Cost-effective, different formulations
Others	Less than 10%	Fragmented	Mainly local or regional players

Note: BETRIHAN (off-label use), emerging biosimilar foam agents.

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Revenue Projections and Financial Trajectory

1. Historical Revenue and Growth Trends

Year	Revenue (USD millions)	CAGR	Notes
2018	40	-	Launch phase steady growth
2019	55	37.5%	Increased adoption
2020	70	27.3%	Pandemic impact mitigated
2021	85	21.4%	Market expansion
2022	105	23.5%	US and European growth

2. Forecasted Revenue (2023–2028)

Year	Projected Revenue (USD millions)	Assumptions	Notes
2023	130	23% growth	Market penetration, new indications
2024	160	23%	Rising adoption in emerging markets
2025	200	25%	Broader reimbursement coverage, regulatory approvals
2026	250	25%	Increased procedural rates
2027	310	24%	Product line extensions, new territories
2028	380	23%	Sustained growth, innovation impact

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Regulatory and Policy Impacts

US Market

• FDA approval (2013): Catapulted VARITHENA into the minimally invasive vein treatment arena.
• Reimbursement codes: CPT 36465, 36466, and 36470 facilitate provider reimbursements.
• Label updates: Expansion to treat additional vein segments (2018).

European Market

• CE Mark (2014): Validates safety and efficacy.
• Guidelines: European Society for Vascular Surgery recommends foam sclerotherapy as first-line therapy in suitable patients.

Emerging Markets

• Regulatory pathways vary; approvals mostly obtained in Brazil, India, and Southeast Asia (2020–2022).

Future Regulatory Trends

• Emphasis on real-world evidence and post-market surveillance may influence approvals and reimbursement policies.

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Strategic Opportunities and Challenges

Opportunities	Challenges
Expanding indications for larger vein segments	Competition from alternative modalities (EVLA, RFA)
Growing awareness and patient preference for minimally invasive procedures	Regulatory hurdles in emerging markets
Product innovation and combination therapies	Cost pressures and reimbursement constraints
Entry into new geographies	Variability in healthcare infrastructure & reimbursement

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Comparative Analysis: VARITHENA vs. Alternative Treatments

Attribute	VARITHENA	EVLA / RFA	Laser Ablation	Surgery (Stripping)
Invasiveness	Non-invasive foam	Minimally invasive	Minimally invasive	Invasive
Recovery Time	1-2 days	Same-day	Same-day	1-2 weeks
Efficacy	High (up to 93% occlusion)	Similar	Comparable	High, but invasive
Complication Rate	Low (1-3%)	Low	Low	Higher (e.g., nerve injury)
Cost	Medium	High	High	High

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Key Market Trends and Future Outlook

• Market Maturation: As VARITHENA garners wider acceptance, market growth will shift from early adopters to mainstream integration.
• Innovation Focus: Development of hybrid techniques, improvements in foam formulations, and combination therapies.
• Digital and Data-driven Approaches: Integration with health records and real-world evidence to demonstrate outcomes.
• Reimbursement Dynamics: Favorable policies will accelerate growth; adverse changes could hamper adoption.
• Global Expansion: Focus on Asia-Pacific, Latin America, and Middle East markets.

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Key Takeaways

• Strong Growth Trajectory: VARITHENA’s sales are projected to grow at approximately 23-25% CAGR through 2028, driven by increased procedural volumes and geographic expansion.
• Market Shares: Dominates the foam segment but faces competition from local and regional players, emphasizing the need for innovation.
• Regulatory and Policy Environment: Favorable in US and Europe, with emerging markets presenting both opportunities and barriers.
• Strategic Focus Areas: Product line extensions, indications expansion, and geographic diversification are vital for sustained growth.
• Challenges: Competitive pressures, reimbursement variability, and technological advancements in alternative modalities require active strategic responses.

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Frequently Asked Questions

Q1: What are the main factors influencing VARITHENA’s market penetration?
Market penetration hinges on clinical efficacy, safety profile, reimbursement policies, physician familiarity, and patient preference for minimally invasive procedures. Evidence from clinical trials (e.g., VARES trial) demonstrates high success rates, supporting adoption.

Q2: How does VARITHENA compare cost-wise to alternative treatments?
While VARITHENA’s direct treatment costs are medium-range, its minimally invasive nature reduces hospital stays and recovery time, lowering overall healthcare costs and patient downtime compared to surgical options.

Q3: What are the regulatory challenges in expanding VARITHENA’s indications?
Regulatory bodies require comprehensive clinical evidence to expand indications, especially for larger veins or complex cases. Post-market surveillance and real-world evidence are increasingly important.

Q4: Which emerging markets present the most growth potential for VARITHENA?
Asia-Pacific (e.g., China, India), Latin America, and the Middle East hold significant growth potential due to expanding healthcare infrastructure, increasing prevalence, and rising awareness.

Q5: What strategic moves should BTG/Boston Scientific consider for future growth?
Investing in product innovations, expanding indications, strengthening global regulatory approval pathways, and forming regional partnerships will be key to maintaining a competitive edge.

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References

1. European Vascular Society guidelines (2020)
2. GlobalData Market Reports (2022)
3. American Heart Association: Varicose Vein Statistics (2021)
4. FDA Advisory Committee Minutes, 2013
5. Boston Scientific Corporate Reports (2022)

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Final Thoughts

VARITHENA remains a pivotal player in the minimally invasive vein treatment landscape. The growth trajectory reflects evolving clinical preferences, favorable regulation, and technological advances. Continued innovation, strategic global expansion, and robust evidence generation will underpin its success in an increasingly competitive market.

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[End of Report]