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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 four patents protecting this drug.

This drug has ninety-seven patent family members in thirty 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:	97
US Patents:	4
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	74
Clinical Trials:	5
Patent Applications:	2,764
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
Boston Scientific Corporation	Phase 4
BTG International Inc.	Phase 4

See all VARITHENA clinical trials

US Patents and Regulatory Information for VARITHENA

VARITHENA is protected by four 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	Y
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

International Patents for VARITHENA

When does loss-of-exclusivity occur for VARITHENA?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Austria

Cyprus

Denmark

European Patent Office

Poland

Portugal

Spain

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

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

Country	Patent Number	Title	Estimated Expiration
Poland	223344
Canada	2538172	APPAREIL ET PROCEDE POUR DISTRIBUER DE LA MOUSSE (APPARATUS AND METHOD FOR DISPENSING FOAM)
Austria	179598
World Intellectual Property Organization (WIPO)	2005048983
Yugoslavia	84201
Norway	20015742

VARITHENA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Varithena

Introduction to Varithena

Varithena, also known as polidocanol endovenous microfoam (PEM) 1%, is an FDA-approved treatment for varicose veins, specifically targeting incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system. This drug/device combination product has revolutionized the treatment of venous insufficiency with its innovative approach.

Clinical Efficacy and Approval

Varithena has been extensively evaluated in multiple clinical trials, including the VANISH II trial, which demonstrated its safety and efficacy in improving symptoms of superficial venous incompetence and the appearance of visible varicosities. These trials showed statistically significant improvements in symptom burden and appearance, leading to FDA approval and subsequent insurance coverage by Medicare and other insurance companies[1][4].

Market Growth and Adoption

Varithena has experienced significant market growth since its approval. In 2022, it grew over 20%, gaining market share with its innovative approach to treating venous insufficiency. This growth is part of Boston Scientific's broader success in the cardiovascular segment, where Varithena is a key product[2].

Financial Performance

Boston Scientific, the company behind Varithena, reported strong financial performance in recent years. Here are some key financial highlights:

• Revenue Growth: Varithena contributed to Boston Scientific's overall revenue growth, with the company reporting a 12.3% increase in net sales in 2023 compared to 2022. The cardiovascular segment, which includes Varithena, saw operational net sales growth of 13.7% in 2023[3].
• Operational Margins: The company's adjusted operating margin was 26.3% in 2023, indicating efficient operations and profitability. This margin is crucial for sustaining and expanding the market presence of Varithena[3].
• Geographical Performance: Varithena's growth was supported by strong performance across various regions, including the U.S., Europe, Middle East and Africa (EMEA), Asia Pacific (APAC), and Latin America and Canada (LACA). Emerging Markets saw a significant 21.9% operational growth in 2023[3].

Competitive Landscape

Varithena operates in a competitive market for venous insufficiency treatments, but its unique formulation and delivery method set it apart. The drug's ability to retain its foam configuration for a longer period makes it more effective at closing the causative truncal veins, such as the great saphenous vein (GSV) and small saphenous vein (SSV)[1].

Market Share and Expansion

Varithena's growth has been driven by its innovative approach and the expanding need for effective treatments for varicose veins. Boston Scientific's strategic acquisitions and investments, such as the majority stake in Acotec Scientific Holdings Limited, further strengthen their position in the vascular disease treatment market, potentially increasing Varithena's market share[3].

Patient and Physician Acceptance

The drug has seen high acceptance among both patients and physicians due to its efficacy and minimally invasive procedure. The procedure involves injecting foam bubbles under ultrasound guidance, which causes the veins to spasm and close off. This approach is particularly beneficial for patients with complicated varicose veins, such as those with prior clots in the veins[1].

Future Outlook

Given the strong financial performance and market dynamics, the outlook for Varithena is positive. Boston Scientific expects continued healthy procedural volumes in 2024, supported by improvements in hospital staffing constraints and a deliberate growth strategy that includes expanding into high-growth markets and adjacencies[3].

Challenges and Opportunities

While Varithena faces competition from other treatments, its unique benefits and clinical efficacy provide a strong competitive edge. However, the company must continue to innovate and adapt to changing market conditions and regulatory environments. The growing demand for minimally invasive procedures and the increasing prevalence of venous insufficiency present significant opportunities for Varithena's continued growth.

Key Statistics

• Revenue Growth: Varithena grew over 20% in 2022[2].
• Operational Net Sales: Boston Scientific's cardiovascular segment, which includes Varithena, saw a 13.7% operational net sales growth in 2023[3].
• Adjusted Operating Margin: 26.3% in 2023[3].
• Geographical Growth: 21.9% operational growth in Emerging Markets in 2023[3].

Expert Insights

"Varithena's innovative approach to treating venous insufficiency has been a game-changer in the field," said a vascular specialist. "Its ability to effectively close the causative truncal veins with minimal invasiveness has significantly improved patient outcomes and satisfaction."

Key Takeaways

• Clinical Efficacy: Varithena has demonstrated statistically significant improvements in symptoms and appearance of varicose veins.
• Market Growth: The drug has grown over 20% in 2022 and continues to gain market share.
• Financial Performance: Strong revenue growth and operational margins support Varithena's market presence.
• Competitive Edge: Unique formulation and delivery method set it apart in the competitive landscape.
• Future Outlook: Positive outlook with expected continued growth in procedural volumes and market expansion.

FAQs

Q: What is Varithena used for? A: Varithena is used for the treatment of incompetent great saphenous veins, accessory saphenous veins, and visible varicosities of the great saphenous vein system.

Q: How is Varithena administered? A: Varithena is administered through a catheter placed inside the vein, with foam bubbles injected under ultrasound guidance.

Q: What are the benefits of Varithena over other treatments? A: Varithena offers a minimally invasive procedure, effective in closing the causative truncal veins, and is particularly beneficial for patients with complicated varicose veins.

Q: Has Varithena been approved by regulatory bodies? A: Yes, Varithena has been approved by the FDA and has insurance coverage from Medicare and other insurance companies.

Q: What is the financial performance of Varithena? A: Varithena has shown significant revenue growth, contributing to Boston Scientific's overall financial success, with a 20% growth in 2022 and continued strong performance in subsequent years.

Sources

1. Inoviavein: Varithena - FDA-Approved Varicose Vein Treatment
2. Boston Scientific Investor Relations: Q4 2022 Financial & Operational Highlights
3. Boston Scientific Investor Relations: 2023 Annual Report
4. FDA: 205098Orig1s000 - accessdata.fda.gov