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Last Updated: December 22, 2024

ASCLERA Drug Patent Profile


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Which patents cover Asclera, and what generic alternatives are available?

Asclera is a drug marketed by Chemisch Fbrk Krsslr and is included in one NDA.

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

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Summary for ASCLERA
US Patents:0
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 74
Clinical Trials: 3
Patent Applications: 2,764
What excipients (inactive ingredients) are in ASCLERA?ASCLERA excipients list
DailyMed Link:ASCLERA at DailyMed
Drug patent expirations by year for ASCLERA
Recent Clinical Trials for ASCLERA

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

SponsorPhase
Massachusetts General HospitalPhase 1
Johns Hopkins UniversityPhase 1
Fundação de Amparo à Pesquisa do Estado de São PauloPhase 4

See all ASCLERA clinical trials

Pharmacology for ASCLERA
Drug ClassSclerosing Agent
Mechanism of ActionSclerosing Activity
Physiological EffectVascular Sclerosing Activity

US Patents and Regulatory Information for ASCLERA

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 ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Chemisch Fbrk Krsslr ASCLERA polidocanol SOLUTION;INTRAVENOUS 021201-002 Mar 30, 2010 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

ASCLERA Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Asclera

Introduction

Asclera, also known as polidocanol, is a key player in the sclerotherapy market, used for the treatment of spider veins and varicose veins. Understanding the market dynamics and financial trajectory of Asclera is crucial for stakeholders, including healthcare professionals, investors, and industry analysts.

Market Size and Growth

The global sclerotherapy market, within which Asclera operates, is projected to grow significantly. As of 2024, the sclerotherapy market was estimated at USD 1.15 billion and is expected to grow at a CAGR of 4.4% from 2025 to 2030[1].

Regional Outlook

North America, particularly the United States, dominates the sclerotherapy market, accounting for a significant revenue share. This dominance is attributed to the high prevalence of varicose veins, technological advancements, and the preference for minimally invasive procedures. The region's market is expected to continue growing due to these factors[1].

Distribution and Market Presence

Asclera's distribution has undergone significant changes. Previously, AngioDynamics served as the exclusive distributor of Asclera in the U.S. However, as of April 2019, Merz North America regained the exclusive distribution rights for Asclera. This shift allows healthcare professionals to purchase Asclera directly from Merz, enhancing its market accessibility and potentially boosting sales[4].

Competitive Landscape

The sclerotherapy market is highly competitive, with several key players including BTG, Kreussler, LGM Pharma, Troikaa, and Merz Pharma. The competitiveness is driven by the rapid adoption of advanced technologies such as foam therapy and ultrasound-guided sclerotherapy. Companies are also engaging in strategic expansions and collaborations to increase their market share and geographical presence[1].

Financial Performance

The financial performance of Asclera is closely tied to the overall performance of its distributors and the broader sclerotherapy market. For instance, AngioDynamics reported a net sales increase of 1.6% in the fiscal 2020 second quarter, but this growth was slightly impacted by the discontinuation of Asclera sales during the fiscal year 2019. Excluding the impact of Asclera, net sales grew by 4.0% year over year[2].

Impact of Distribution Changes

The transition of Asclera's distribution from AngioDynamics to Merz North America has significant implications for the financial trajectory. Merz North America's direct distribution model is expected to streamline the supply chain and potentially increase sales volume by making the product more accessible to a wider range of healthcare professionals[4].

Technological Advancements

Technological advancements in sclerotherapy, such as foam therapy and ultrasound-guided sclerotherapy, are driving the market growth. These advancements improve the efficacy and safety of treatments, making them more appealing to patients and healthcare providers. Asclera, being a key product in this space, benefits from these technological improvements[1].

Demographic Factors

The increasing geriatric population and the rising incidence of varicose veins among this demographic are significant drivers for the sclerotherapy market. In the U.S. and Europe, up to 35% of the population suffers from varicose veins, with a high prevalence among women and those with a family history. These demographic factors contribute to the growing demand for Asclera and other sclerotherapy treatments[1].

Economic and Regulatory Factors

Economic factors such as healthcare spending and regulatory environments also influence the market. The cost-effectiveness of treatments, including the impact of drug price dynamics, plays a crucial role in their adoption. For instance, studies have shown that drug price increases during the exclusivity period and subsequent price decreases after the loss of exclusivity can significantly affect the cost-effectiveness of treatments[3].

Key Takeaways

  • Market Growth: The sclerotherapy market, including Asclera, is expected to grow at a CAGR of 4.4% from 2025 to 2030.
  • Regional Dominance: North America, particularly the U.S., dominates the market due to high technological advancements and a high prevalence of varicose veins.
  • Distribution Changes: Merz North America's regain of exclusive distribution rights for Asclera is expected to enhance market accessibility and sales.
  • Technological Advancements: Advances in foam therapy and ultrasound-guided sclerotherapy drive market growth.
  • Demographic Drivers: The increasing geriatric population and high incidence of varicose veins among this demographic drive demand.

FAQs

  1. What is Asclera used for? Asclera, or polidocanol, is used for the treatment of spider veins and varicose veins through sclerotherapy.

  2. Who is the current distributor of Asclera in the U.S.? As of April 2019, Merz North America is the exclusive distributor of Asclera in the U.S.[4].

  3. What are the key drivers of the sclerotherapy market? Key drivers include the increasing geriatric population, technological advancements, and the high demand for minimally invasive procedures[1].

  4. How does the distribution change from AngioDynamics to Merz North America impact Asclera's market presence? The change allows healthcare professionals to purchase Asclera directly from Merz, potentially increasing sales volume and market accessibility[4].

  5. What is the projected growth rate of the global sclerotherapy market? The global sclerotherapy market is projected to grow at a CAGR of 4.4% from 2025 to 2030[1].

Sources

  1. Grand View Research: Sclerotherapy Market Size And Share | Industry Report, 2030
  2. AngioDynamics: AngioDynamics Reports Fiscal 2020 Second Quarter Financial
  3. PubMed: The Influence of US Drug Price Dynamics on Cost-Effectiveness
  4. EVToday: Merz North America Regains Exclusive Distribution of Asclera Injection

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