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
Spain	2281465
World Intellectual Property Organization (WIPO)	0077146
Eurasian Patent Organization	003845	СПОСОБ ПОЛУЧЕНИЯ ГРАНУЛИРОВАННЫХ МОЮЩИХ СОСТАВОВ (PROCESS FOR PREPARING GRANULAR DETERGENT COMPOSITIONS)
European Patent Office	1694292	MOUSSE THERAPEUTIQUE AVEC UNE SOLUTION SCLEROSEE ET UNE QUANTITÉ BASSE DU NITROGÈNE GASEUZ (THERAPEUTIC FOAM COMPRISING A SCLEROSING SOLUTION AND A LOW QUANITIY OF GASEOUS NITROGEN)
Taiwan	482671
Austria	313317
Portugal	1673293

Market Dynamics and Financial Trajectory for Varithena

Last updated: July 27, 2025

Introduction

Varithena (polidocanol injectable foam), marketed by Philip Morris International’s newly established pharmaceutical arm, is an injectable foam used primarily for treating symptomatic varicose veins and incompetent great saphenous veins. Since its FDA approval in 2013 under the Vascular Solutions brand, Varithena has carved a niche within minimally invasive vein treatments. Its market trajectory reflects evolving clinical preferences, regulatory landscapes, and competitive pressures shaping the broader vein treatment sector. This report analyzes the market dynamics influencing Varithena’s financial prospects and strategic positioning.

Market Environment and Therapeutic Landscape

Market Size and Growth Potential

The global varicose veins treatment market is valued at approximately USD 1.2 billion in 2023, with an expected compound annual growth rate (CAGR) of about 5% through 2028 ([1]). The increasing prevalence of chronic venous diseases, especially among aging populations, underpins this trajectory. As of 2023, over 25 million Americans suffer from varicose veins, with substantial healthcare expenditures directed toward minimally invasive interventions.

Therapeutic Alternatives and Market Preferences

Varithena faces competition from multiple modalities:

• Endovenous laser ablation (EVLA): Dominates the market due to established efficacy.
• Radiofrequency ablation (RFA): Similar to EVLA in minimally invasive profile.
• Sclerotherapy: Common for smaller varicose and spider veins.
• Traditional surgery: High invasiveness renders it less favorable.

In recent years, the minimally invasive nature and outpatient convenience of foam-based treatments like Varithena and other cyanoacrylate adhesives have gained favor, especially for patients contraindicated for thermal ablation.

Regulatory and Reimbursement Dynamics

The therapy’s success heavily relies on robust reimbursement policies. CMS and private insurers increasingly favor minimally invasive approaches, recognizing their cost-effectiveness and safety profile ([2]). However, reimbursement rates remain variable across regions and modalities, impacting profit margins and adoption rates.

Market Dynamics Influencing Varithena

Clinical Efficacy and Safety Profile

Varithena’s advantages include reduced post-procedural pain and bruising compared to thermal techniques. Nevertheless, it faces scrutiny over concerns of embolization risks and lack of long-term comparative data. The European guidelines recommend thermal ablation as first-line, yet, in North America, foam treatments retain substantial market share.

Manufacturing and Supply Chain Factors

Raw material costs, especially for polidocanol, influence profitability. The scalability of foam manufacturing, quality consistency, and regulatory compliance are critical. Any disruptions could affect supply and revenues.

Competitive Landscape and Market Penetration

Major competitors include Luminary’s Varithena and alternative treatment brands like Asclera (also polidocanol), which targets small veins. The entry of emerging cyanoacrylate adhesives and mechanochemical ablation devices further complicates market share allocation.

Brand Recognition and Physician Adoption

Physician familiarity, institutional protocols, and reimbursement incentives drive adoption. Ongoing clinical trials and real-world evidence (RWE) outcomes influence clinician confidence.

Pricing Strategies

Varithena’s premium pricing stems from its specialized formulation. Market penetration may require strategic adjustments, especially in cost-sensitive sectors and international markets.

Financial Trajectory and Future Outlook

Revenue Projections

Based on current market penetration and growth rates, Varithena’s revenue in North America is projected to grow at a CAGR of approximately 4-6% over the next five years ([3]). Global expansion, particularly in Europe and Asia, presents additional revenue streams, contingent on regulatory approvals.

Cost Management and Investment

Investments in clinical research, marketing campaigns, and manufacturing innovation are essential. Cost containment measures and strategic alliances with healthcare providers can optimize margins.

Innovation and Pipeline Development

Developments in adjunctive therapies, improved foam formulations, and combination treatments could expand indications and usage volume. Monitoring emerging data on alternative treatments is crucial to adapt strategies proactively.

Regulatory Pathways and Market Entry

Expanding approval for broader indications, such as recurrent varicose veins or cosmetic applications, can substantially boost market size. Streamlining regulatory processes and engaging with health authorities will accelerate commercialization efforts.

Strategic Opportunities and Challenges

• Opportunities: Capitation of emerging markets, integration with digital health solutions, and partnerships with healthcare systems for bundled treatments.
• Challenges: Competition from off-label uses, patent expirations, and clinical skepticism regarding long-term efficacy.

Key Takeaways

• The global vein treatment market is growing steadily, driven by demographic shifts and technological advances.
• Varithena’s financial success hinges on clinical adoption, reimbursement policies, and competitive positioning.
• Technological innovation and targeted marketing are pivotal to increasing market share.
• International expansion, especially regulatory approvals, offers significant growth potential.
• Cost management and evidence generation remain critical for sustainable profitability.

Conclusion

Varithena’s market dynamics are shaped by a confluence of clinical, regulatory, and competitive factors. While current growth prospects are favorable, sustained success depends on strategic adaptation to evolving clinician preferences, technological innovations, and reimbursement landscapes. Companies that effectively leverage these insights can optimize their financial trajectories and secure enduring market presence.

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FAQs

1. What are the main advantages of Varithena over traditional vein treatments?
Varithena offers minimally invasive administration, reduced post-procedure discomfort, and outpatient convenience, making it a preferred alternative for suitable patients.

2. How does reimbursement influence Varithena’s market penetration?
Reimbursement policies significantly impact physician adoption; favorable coverage encourages procedural volume, while delays or restrictions hamper growth.

3. What is the competitive outlook for Varithena in the next five years?
Intense competition from thermal ablation, adhesives, and emerging modalities necessitates continuous innovation, clinical validation, and strategic marketing to maintain and grow market share.

4. Are international markets a viable expansion opportunity for Varithena?
Yes, particularly in regions with rising prevalence of venous diseases and receptive regulatory environments. Success depends on local clinical acceptance and reimbursement structures.

5. What factors could threaten Varithena’s financial trajectory?
Emerging evidence favoring alternative treatments, patent expirations, regulatory hurdles, and pricing pressures could adversely affect revenue streams.

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References

[1] MarketWatch. "Varicose Veins Treatment Market Size, Share & Trends Analysis Report." 2023.
[2] American Vein & Lymphatic Society. "Reimbursement Landscape for Venous Treatments." 2022.
[3] IBISWorld. "Global Varicose Veins Treatment Market Report." 2023.