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Last Updated: December 22, 2024

SOTRADECOL Drug Patent Profile


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Which patents cover Sotradecol, and when can generic versions of Sotradecol launch?

Sotradecol is a drug marketed by Elkins Sinn and Mylan Institutional and is included in two NDAs.

The generic ingredient in SOTRADECOL is sodium tetradecyl sulfate. There are one thousand four hundred and seventy-two drug master file entries for this compound. Three suppliers are listed for this compound. Additional details are available on the sodium tetradecyl sulfate profile page.

DrugPatentWatch® Litigation and Generic Entry Outlook for Sotradecol

A generic version of SOTRADECOL was approved as sodium tetradecyl sulfate by HIKMA on December 9th, 2019.

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Drug patent expirations by year for SOTRADECOL
Recent Clinical Trials for SOTRADECOL

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SponsorPhase
American Rhinologic SocietyPhase 1/Phase 2
University of Minnesota - Clinical and Translational Science InstitutePhase 1/Phase 2
University of MinnesotaPhase 1/Phase 2

See all SOTRADECOL clinical trials

US Patents and Regulatory Information for SOTRADECOL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Elkins Sinn SOTRADECOL sodium tetradecyl sulfate INJECTABLE;INJECTION 005970-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Mylan Institutional SOTRADECOL sodium tetradecyl sulfate INJECTABLE;INJECTION 040541-002 Nov 12, 2004 AP RX No Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Elkins Sinn SOTRADECOL sodium tetradecyl sulfate INJECTABLE;INJECTION 005970-005 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  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

SOTRADECOL Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Sotradecol

Introduction

Sotradecol, also known as sodium tetradecyl sulfate, is a sclerosing agent widely used in the treatment of varicose and spider veins. This article delves into the market dynamics and financial trajectory of Sotradecol, highlighting key factors influencing its market share, growth prospects, and associated financial aspects.

Market Size and Growth

The global sclerotherapy market, which includes Sotradecol, was valued at USD 1,011.7 million in 2022 and is projected to reach USD 1,768.1 million by 2031, registering a Compound Annual Growth Rate (CAGR) of 6.4% during the forecast period (2023-2031)[1].

Key Drivers of Market Growth

Several factors drive the growth of the sclerotherapy market, including:

Growing Elderly Population

The increasing elderly population is a significant driver. In the United States, for instance, about 17.3% of the population was 65 years or older in 2022, a percentage expected to rise to 22% by 2050. This demographic shift increases the demand for treatments like sclerotherapy, which is commonly used to address varicose veins prevalent in older adults[1].

Rising Incidence of Varicose Veins

Varicose veins affect a substantial portion of the population, with approximately 40% of adults in Europe experiencing chronic venous illness. In the United States, over 40 million individuals suffer from varicose veins, with about 50% reporting a familial predisposition[1].

Technological Improvements

Advancements in venous disorder treatments and the development of more effective sclerosing agents like Sotradecol contribute to market growth. These improvements enhance the efficacy and safety of sclerotherapy procedures[1].

Preference for Minimally Invasive Procedures

The increasing preference for minimally invasive treatments also boosts the market. Sclerotherapy, being a less invasive option, is gaining popularity over traditional surgical methods[1].

Regional Market Analysis

North America

North America is the largest market shareholder for sclerotherapy, driven by the high prevalence of varicose veins and the presence of a large elderly population. This region is expected to grow at a CAGR of 6.5% during the forecast period[1].

Europe

Europe is another significant market, with sclerotherapy being a common therapeutic intervention for varicose and spider veins. The European market is influenced by factors such as the incidence of venous disorders, technological advancements, and patient preferences[1].

Asia Pacific

The Asia Pacific region is the fastest-growing market, driven by an increasing elderly population and rising healthcare expenditure. In East and North-East Asia, the proportion of older individuals is projected to increase significantly, contributing to the growth of the sclerotherapy market[1].

Financial Trajectory

Revenue Projections

The projected growth of the sclerotherapy market from USD 1,011.7 million in 2022 to USD 1,768.1 million by 2031 indicates a robust financial trajectory for Sotradecol and other sclerosing agents. This growth is driven by the increasing demand for effective treatments for varicose and spider veins[1].

Cost and Pricing

While specific pricing data for Sotradecol is not provided, the overall trend in the pharmaceutical market suggests that costs can increase over time. For instance, studies on other injectable drugs have shown that prices can rise substantially after launch, even after adjusting for inflation[3].

Pharmacological and Clinical Aspects

Mechanism of Action

Sotradecol works by causing inflammation and thrombus formation in the injected vein, leading to its occlusion and eventual obliteration. This process results in the reduction or elimination of varicose veins[2].

Indications and Contraindications

Sotradecol is indicated for the treatment of small, uncomplicated varicose veins with competent valves. However, it has contraindications and potential adverse effects, including deep venous thrombosis, air embolism, local reactions, allergic reactions, and systemic reactions[2].

Adverse Effects and Safety Considerations

Serious Adverse Events

Sotradecol can cause serious adverse events such as deep venous thrombosis, pulmonary embolism, and anaphylactic shock. There have been reported cases of death associated with its use, although these are rare[2][4].

Monitoring and Precautions

Patients must be evaluated for valvular competency and deep venous patency before treatment. Post-treatment monitoring for complications such as deep vein thrombosis and pulmonary embolism is also recommended[2].

Regulatory Environment

FDA Designation

Sotradecol has been designated as an orphan drug by the FDA for the treatment of gastrointestinal bleeding due to esophageal varices, highlighting its specialized use and potential for regulatory support[2].

Market Competition

The sclerotherapy market is characterized by the presence of multinational corporations and ongoing research and development. The competition is driven by technological advancements and the introduction of new sclerosing agents, which can impact the market share of Sotradecol[1].

Conclusion

The market dynamics and financial trajectory for Sotradecol are influenced by a combination of demographic, technological, and clinical factors. As the global sclerotherapy market continues to grow, driven by the increasing elderly population and the preference for minimally invasive treatments, Sotradecol is poised to remain a significant player.

Key Takeaways

  • The global sclerotherapy market is projected to grow from USD 1,011.7 million in 2022 to USD 1,768.1 million by 2031.
  • North America is the largest market shareholder, with Europe and Asia Pacific also being significant regions.
  • The growing elderly population and technological improvements are key drivers of market growth.
  • Sotradecol is indicated for the treatment of small, uncomplicated varicose veins but has potential adverse effects that require careful monitoring.
  • The regulatory environment, including FDA designations, supports the specialized use of Sotradecol.

FAQs

What is Sotradecol used for?

Sotradecol (sodium tetradecyl sulfate) is used in the treatment of small, uncomplicated varicose veins of the legs showing simple dilation, with competent valves[2].

What are the potential adverse effects of Sotradecol?

Potential adverse effects include deep venous thrombosis, air embolism, local reactions, allergic reactions, and systemic reactions. Rare but serious events include anaphylactic shock and death[2][4].

How does Sotradecol work?

Sotradecol causes inflammation and thrombus formation in the injected vein, leading to its occlusion and eventual obliteration[2].

What is the projected growth of the sclerotherapy market?

The global sclerotherapy market is projected to grow from USD 1,011.7 million in 2022 to USD 1,768.1 million by 2031, registering a CAGR of 6.4% during the forecast period[1].

Which regions are the largest markets for Sotradecol?

North America is the largest market shareholder, followed by Europe and the Asia Pacific region, which is the fastest-growing market[1].

Sources

  1. Sclerotherapy Market Size, Share and Trends Analysis Report 2031 - Straits Research
  2. Tetradecyl hydrogen sulfate (ester) - DrugBank
  3. Trajectories of Injectable Cancer Drug Costs After Launch - PubMed
  4. Sotradecol (sodium tetradecyl sulfate) approved label - FDA

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