Last Updated: June 9, 2026

Sodium tetradecyl sulfate - Generic Drug Details


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What are the generic sources for sodium tetradecyl sulfate and what is the scope of freedom to operate?

Sodium tetradecyl sulfate is the generic ingredient in two branded drugs marketed by Hikma, Elkins Sinn, and Mylan Institutional, and is included in three NDAs. Additional information is available in the individual branded drug profile pages.

There are four drug master file entries for sodium tetradecyl sulfate. Three suppliers are listed for this compound.

Summary for sodium tetradecyl sulfate
US Patents:0
Tradenames:2
Applicants:3
NDAs:3
Drug Master File Entries: 4
Finished Product Suppliers / Packagers: 3
Raw Ingredient (Bulk) Api Vendors: 42
Clinical Trials: 11
Patent Applications: 3,229
What excipients (inactive ingredients) are in sodium tetradecyl sulfate?sodium tetradecyl sulfate excipients list
DailyMed Link:sodium tetradecyl sulfate at DailyMed
Recent Clinical Trials for sodium tetradecyl sulfate

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

SponsorPhase
Goldman, Butterwick, Fitzpatrick and GroffPHASE4
University of California, Los AngelesNA
Goldman, Butterwick, Fitzpatrick and GroffPhase 2

See all sodium tetradecyl sulfate clinical trials

Medical Subject Heading (MeSH) Categories for sodium tetradecyl sulfate
Anatomical Therapeutic Chemical (ATC) Classes for sodium tetradecyl sulfate

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
Elkins Sinn SOTRADECOL sodium tetradecyl sulfate INJECTABLE;INJECTION 005970-004 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Mylan Institutional SOTRADECOL sodium tetradecyl sulfate INJECTABLE;INJECTION 040541-002 Nov 12, 2004 AP RX No Yes ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Elkins Sinn SOTRADECOL sodium tetradecyl sulfate INJECTABLE;INJECTION 005970-005 Approved Prior to Jan 1, 1982 DISCN Yes No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
Mylan Institutional SOTRADECOL sodium tetradecyl sulfate INJECTABLE;INJECTION 040541-001 Nov 12, 2004 RX No Yes ⤷  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
Last updated: April 25, 2026

Market dynamics and financial trajectory for sodium tetradecyl sulfate

Sodium tetradecyl sulfate (STS), an injected sclerosant used primarily for vascular indications, is a mature, relatively low-cost, revenue-stable therapy in many markets. The commercial trajectory is driven by (1) procedural demand in dermatology and vascular medicine, (2) payer and guideline patterns that favor cost-effective first-line sclerosants, (3) competitive intensity from multiple branded and generic sclerosant products, and (4) the degree to which supply continuity and formulation/labeling differences determine tender wins and hospital formularies. Because STS is generally off-patent in major jurisdictions, the market is structurally shaped by generics and authorized duplicates rather than by branded patent exclusivity.

What is the commercial role of sodium tetradecyl sulfate in practice?

STS is used as an injectable sclerosant for the treatment of superficial venous and related vascular conditions. Real-world uptake depends less on large-scale R&D diffusion and more on procedural throughput, site-of-care economics (clinic versus outpatient hospital), and local treatment protocols that specify the sclerosant, concentration, volume range, and administration technique.

Key demand drivers by channel:

  • Outpatient procedure markets: clinics that schedule elective vascular and dermatology procedures monetize repeat utilization and staff utilization.
  • Hospital outpatient units: formularies and tenders typically reward established products with reliable supply and predictable unit costs.
  • Private payer and cash-pay segments: price sensitivity matters, since STS is often bundled into procedure fees rather than reimbursed at a high standalone price.

How do competitive dynamics shape pricing and share?

STS is exposed to classic post-patent competition patterns:

  • Generic entry and parallel product offerings: where multiple approved generic or authorized equivalent products exist, price compression tends to follow.
  • Tender-driven procurement: national and regional hospital systems procure based on unit price, supply reliability, and labeling match to protocol. This reduces brand pricing power.
  • Concentration and presentation differences: small formulation or packaging differences can create practical barriers to switching for established providers, even when active ingredient equivalence is present.

Implication for market dynamics: the market behaves like a procedural commodity rather than a premium specialty drug. Financial trajectory typically tracks procedure volume and inflation-adjusted tender pricing, with margin risk from repeated price resets.


Supply, regulation, and formulation effects

What determines whether manufacturers sustain revenue through cycles?

For mature injectables like STS, revenue survival is less about clinical breakthroughs and more about operational and regulatory durability:

  • Production continuity and batch release performance influence whether hospitals keep a supplier under a tender cycle.
  • Label alignment with local clinical protocols reduces friction for adoption and switching.
  • Distribution footprint (secondary logistics, temperature and handling requirements) affects real-world availability.

Even when clinical demand remains stable, intermittent supply issues can cause temporary substitution with competitors, transferring revenue across suppliers rather than expanding the overall market.

How does indication scope affect market resilience?

STS is tied to vascular/procedural indications. Markets with strong outpatient procedure volumes and established sclerosant workflows tend to show steadier demand. Conversely, where reimbursement or clinical practice shifts toward alternative sclerosants, foam formulations, or different class agents, STS volumes can decline even if overall venous treatment incidence stays constant.


Financial trajectory: what the business outcomes typically look like

What is the expected revenue pattern post-patent?

Given the mature nature and high likelihood of off-patent status for many STS presentations in major markets, the financial trajectory generally shows:

  • Stable or declining unit pricing as competitive generics and authorized equivalents compete on price.
  • Revenue stability driven by volume rather than by price.
  • Margin pressure as procurement shifts toward the lowest-cost compliant supply option.
  • Customer retention via supply and protocol fit rather than by differentiation.

This profile produces a “flat-to-down” revenue-to-EV multiple behavior in company valuations when growth is primarily volume-led.

How do cost structure and procurement mechanics drive margins?

Injectables have non-trivial manufacturing and quality overhead. In mature markets:

  • COGS and yield efficiency matter more than patent economics.
  • Regulatory and quality assurance costs remain constant while unit pricing falls.
  • Working capital can be more volatile in tender-based markets with periodic replenishment orders.

Result: margin compression tends to persist unless a manufacturer holds a regional cost advantage or maintains a supply win long enough to amortize fixed costs.


Market sizing logic and where money typically concentrates

Where does STS revenue concentrate in the value chain?

In practice, value concentrates in:

  • Supplier-hospital contracts (unit volume multiplied by tender cycle duration).
  • Procedure-provider contracts that influence consistent product usage.
  • Regions with strong outpatient procedural throughput and established venous treatment adoption.

Less money is captured in markets where:

  • providers rapidly switch sclerosants based on short tender cycles,
  • reimbursement constraints force the use of the lowest-price option,
  • product access is disrupted by discontinuations or manufacturing constraints.

How do treatment guidelines influence financial outcomes?

Guideline alignment reduces adoption friction. When local guidance specifies STS or lists it among accepted sclerosants, it stabilizes prescribing behavior and tender demand. When clinical pathways shift toward other sclerosants or administration techniques, STS may lose procedural share even when incidence of the underlying condition is unchanged.


Competitive landscape: how “substitutes” impact trajectory

What competes with STS beyond branded rivals?

STS faces competition from:

  • Other sclerosants (same therapeutic intent, different active formulations).
  • Foam versus liquid administration practices depending on local standards and clinician preference.
  • Endovenous and procedural alternatives that may reduce the number of sclerosant-required sessions in certain patient cohorts.

In mature markets, even when STS remains an accepted therapy, substitutes can cap market growth and limit pricing power.


Investment and R&D lens: why STS behaves differently from pipeline drugs

STS is an example of a mature injectable where:

  • Patent cliffs are less relevant at the drug level than they are at the product presentation level (brand exclusivity or specific formulation approvals).
  • R&D value is concentrated in product lifecycle management (formulation, manufacturing scale, labeling updates, and market access rather than breakthrough efficacy).
  • Commercial returns depend on operational execution: regulatory maintenance, supply continuity, and tender procurement wins.

For investors, this usually translates into a focus on:

  • cash-flow durability,
  • market share stability in tender regions,
  • and supplier reliability indicators.

Key Takeaways

  • Sodium tetradecyl sulfate is commercially shaped by procedural demand and procurement mechanics rather than by branded patent economics.
  • Competitive intensity from generics and authorized equivalents drives persistent unit price pressure and margin compression.
  • Revenue trajectory is typically flat-to-down, with stability coming from volume and contract retention, not price growth.
  • Substitute sclerosants and evolving practice patterns can limit share growth even when underlying disease incidence remains stable.
  • Financial outcomes depend on operational reliability, batch supply continuity, and label-to-protocol fit that wins tenders.

FAQs

1) Is sodium tetradecyl sulfate typically a high-growth market?

No. The commercial pattern is generally mature and volume-led, with pricing pressure from generic competition and tender-driven procurement.

2) What most affects STS revenues in hospitals and clinics?

Tender outcomes and supply continuity, plus whether the product concentration and labeling match local administration protocols.

3) What drives margin changes for STS manufacturers?

Unit price compression, manufacturing and quality cost coverage, and working capital impacts from periodic replenishment cycles under contracted purchasing.

4) What are the main substitution risks for STS?

Switching to other sclerosants, changes in administration technique preferences, and procedure pathway shifts that reduce reliance on sclerosant injections.

5) How does off-patent status affect the financial trajectory?

It usually reduces pricing power and pushes growth reliance toward volume retention and market access rather than premium brand economics.


References

[1] FDA. (n.d.). Orange Book: Approved Drug Products with Therapeutic Equivalence Evaluations. U.S. Food and Drug Administration. https://www.accessdata.fda.gov/scripts/cder/daf/
[2] European Medicines Agency. (n.d.). European public assessment reports and medicines information. European Medicines Agency. https://www.ema.europa.eu/
[3] National Library of Medicine. (n.d.). Drug and indicator records and bibliographic sources. PubMed. https://pubmed.ncbi.nlm.nih.gov/

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