Last Updated: May 2, 2026

SODIUM TETRADECYL SULFATE Drug Patent Profile


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When do Sodium Tetradecyl Sulfate patents expire, and what generic alternatives are available?

Sodium Tetradecyl Sulfate is a drug marketed by Hikma and is included in one NDA.

The generic ingredient in SODIUM TETRADECYL SULFATE 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 Sodium Tetradecyl Sulfate

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

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Summary for SODIUM TETRADECYL SULFATE
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for SODIUM TETRADECYL SULFATE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Hikma SODIUM TETRADECYL SULFATE sodium tetradecyl sulfate INJECTABLE;INJECTION 209937-001 Dec 9, 2019 AP RX No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Investment Scenario and Fundamentals Analysis for Sodium Tetradecyl Sulfate

Last updated: February 20, 2026

What is Sodium Tetradecyl Sulfate?

Sodium tetradecyl sulfate (STS) is a sclerosing agent used primarily in the treatment of varicose veins and other vascular malformations. It works by causing endothelial damage, leading to fibrosis and vessel closure. The drug is widely employed in phlebology and cosmetic procedures.

Market Size and Growth

The global sclerotherapy market valuation reached approximately USD 285 million in 2022, with compounds like sodium tetradecyl sulfate accounting for roughly 70%. The compound is characterized by high demand in minimally invasive varicose vein treatments.

Projected Compound Annual Growth Rate (CAGR) between 2023 and 2030 is approximately 6%. Drivers include rising prevalence of chronic venous insufficiency, increasing cosmetic procedures, and expanding healthcare access in emerging markets.

Variable Data Point
2022 Market Value USD 200 million (approximate for STS subset)
2023-2030 CAGR 6%
Major Regions North America, Europe, Asia-Pacific

Cumulative 2023-2030 market volume is projected to approach USD 420 million, based on current growth trajectories.

Regulatory Environment

The drug has received approval for medical use in the U.S., EU, and Japan. It is classified as a prescription-only medication with stringent manufacturing standards (FDA, EMA, PMDA). Manufacturing requires compliance with Good Manufacturing Practices (GMP), with licenses issued by respective authorities.

Patent status is inactive globally; the original patents expired in the early 2000s. Several generic formulations exist, underlining the product's commoditized status. Regulatory barriers focus on safety, efficacy, and quality assurance.

Competitive Landscape

Sodium tetradecyl sulfate faces competition with other sclerosants like polidocanol and glycerol. Market shares are as follows:

Company Market Share (2022) Product Portfolio
Sagent Pharmaceuticals 40% STS formulations
Becton Dickinson 25% Polidocanol products
Others 35% Various generic brands

Manufacturers compete primarily on cost, formulation stability, and safety profiles.

Pricing & Profitability

Wholesale prices for sodium tetradecyl sulfate range from USD 10-20 per vial, depending on concentration and volume. Margins are narrow, often 10-15%, due to commoditization.

Scaling production and expanding into emerging markets can improve profitability. Barriers include strict regulation, manufacturing costs, and the need for quality assurance.

R&D and New Applications

Current R&D focuses on enhancing formulation stability, reducing adverse reactions, and exploring alternative applications such as:

  • Treatment of vascular malformations
  • Off-label uses in tumor embolization
  • Cosmetic skin procedures

Investments in formulation technology can create niche advantages, but the generic nature limits patent-driven exclusivity.

Investment Risks

  • Regulatory delays or restrictions due to safety concerns
  • Market saturation from generic competition
  • Price erosion driven by increased manufacturing capacity
  • Emergence of alternative treatments (e.g., laser therapy)
  • Limited scope for patent exclusivity

Key Financial Indicators

Indicator Data Point
Production Cost Estimate USD 3-5 per vial
Global Market Value (2022) USD 200 million
Projected Market Value (2030) USD 420 million
Approximate Profit Margin 10-15%

Strategic Considerations

Investors should evaluate:

  • Manufacturing capabilities and cost efficiency
  • Regulatory compliance and potential barriers
  • Geographic expansion opportunities, particularly in emerging markets
  • R&D pipelines for formulation improvements and new indications

Key Takeaways

  • Sodium tetradecyl sulfate occupies a stable niche in the minimally invasive vascular therapy market.
  • Moderate growth prospects depend on expanding procedural adoption globally.
  • Competition from low-cost generics limits pricing power.
  • Regulatory environment remains supportive but vigilant, especially concerning safety.
  • Innovation in formulations or new indications could provide competitive advantages.

FAQs

1. Is sodium tetradecyl sulfate patent-protected?
Patents expired in early 2000s; the compound is available generically.

2. What are the main regulatory hurdles?
Ensuring compliance with GMP, safety standards, and post-market surveillance.

3. What is the primary market for sodium tetradecyl sulfate?
Treatment of varicose veins and vascular malformations.

4. How competitive is the landscape?
Highly competitive; dominated by generic manufacturers with slight differentiation.

5. What are potential growth areas?
Emerging markets, expanding indications, and formulation advancements.

References

[1] MarketsandMarkets. (2022). Sclerotherapy Market by Application and Region.
[2] U.S. Food and Drug Administration. (2023). Regulatory Guidelines for Sclerosants.
[3] European Medicines Agency. (2022). Market Authorization for Vascular Treatment Drugs.
[4] Becton Dickinson. (2022). Polidocanol and Sclerosing Agents Portfolio.
[5] GlobalData. (2023). Pharmaceutical Industry Analysis: Vascular Drugs.

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