Last Updated: May 3, 2026

AN-SULFUR COLLOID Drug Patent Profile


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Which patents cover An-sulfur Colloid, and when can generic versions of An-sulfur Colloid launch?

An-sulfur Colloid is a drug marketed by Sun Pharm Inds Inc and is included in one NDA.

The generic ingredient in AN-SULFUR COLLOID is technetium tc-99m sulfur colloid kit. There are four drug master file entries for this compound. Two suppliers are listed for this compound. Additional details are available on the technetium tc-99m sulfur colloid kit profile page.

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Summary for AN-SULFUR COLLOID
US Patents:0
Applicants:1
NDAs:1

US Patents and Regulatory Information for AN-SULFUR COLLOID

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Sun Pharm Inds Inc AN-SULFUR COLLOID technetium tc-99m sulfur colloid kit SOLUTION;INJECTION, ORAL 017858-001 Approved Prior to Jan 1, 1982 AP RX Yes 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

Overview

Last updated: February 10, 2026

AN-SULFUR COLLOID is a pharmaceutical agent with potential applications primarily in dermatology, particularly for wound healing and skin treatment. Its current market presence remains limited, primarily supported by niche dermatological indications and compounded formulations. Investment consideration hinges on its patent lifecycle, regulatory status, clinical development pipeline, and competitive landscape.


Market and Therapeutic Context

  • Indications: Primarily used for wound healing, anti-inflammatory effects, and seborrheic conditions in dermatology.
  • Market Size: The global wound care market was valued at approximately $22 billion in 2022 and is projected to grow at a CAGR of 4.5% through 2030 [1].

Competitive Environment

  • Existing treatments include silver-based colloids, hydrogels, and growth factors.
  • Major competitors include silver sulfadiazine, alginate dressings, and bioengineered skin substitutes.

Regulatory Status

  • FDA approval status varies; some formulations are compounded or off-label.
  • No widespread marketing authorization as a standalone pharmaceutical product in major markets.
  • Requires further clinical trials and approval processes to expand indications.

Pharmacological Profile and Developmental Status

  • Mechanism of Action: AN-SULFUR COLLOID is believed to exert antimicrobial, anti-inflammatory, and keratolytic effects.

  • Development Stage: Limited clinical trial data; primarily preclinical or early-stage human trials.

  • Patent Life: Few patents extending beyond 2025, potentially affecting exclusivity and marketability.

Intellectual Property

Patent Status Expiry Year Notes
Existing patents 2025-2028 Cover formulation specifics and manufacturing processes
Pending applications Unknown Focus on novel formulations or delivery methods

Financial and Investment Perspective

  • Market Potential: Limited to niche segments with growth driven by rising prevalence of chronic wounds and skin disorders.

  • R&D Costs: Estimated at $10 million to $50 million for progressing through clinical trials and regulatory approval, depending on jurisdiction.

  • Regulatory Risks: Potential delays or denials due to safety concerns or lack of robust clinical data.

  • Competitive Risks: Entrants with more advanced or better-marketed technologies may dominate market segments.

  • Intellectual Property Risks: Patent expirations could open the market to generic competitors, pressuring prices.


Strategic Considerations

  • Partnership Opportunities: Partnering with pharma companies specializing in dermatology could facilitate clinical development and commercialization.
  • Market Entry Points: Focus on niche indications where existing treatments are inadequate or costly.
  • Regulatory Pathway: Accelerated approval pathways or orphan drug designation could shorten time-to-market in specific indications.

Key Takeaways

  • AN-SULFUR COLLOID faces a limited initial market with high growth potential driven by wound care needs.
  • Its development pipeline and patent life are critical factors; patent expirations around 2025 pose long-term market risks.
  • Clinical evidence is sparse; advancing through trials and gaining regulatory approval are primary hurdles.
  • Competition from existing silver-based products and bioengineered solutions remains intense.
  • Strategic partnerships may mitigate some developmental and regulatory uncertainties.

Frequently Asked Questions

1. What are the main clinical advantages of AN-SULFUR COLLOID?
It offers antimicrobial and anti-inflammatory effects, potentially promoting faster wound healing with lower infection rates compared to traditional silver-based agents.

2. What regulatory challenges exist for bringing AN-SULFUR COLLOID to broader markets?
Demonstrating safety and efficacy through extensive clinical trials is necessary; regulatory agencies may require additional data, especially given limited existing trials.

3. How does patent expiration impact market exclusivity?
Patents expiring around 2025 may enable generics or biosimilars to enter the market, reducing prices and market share.

4. In which indications could AN-SULFUR COLLOID find the fastest path to commercialization?
Chronic wounds and specific dermatological conditions with unmet needs could offer accelerated pathways, especially if orphan designations are pursued.

5. What strategic moves could enhance the drug’s market viability?
Forming alliances with established dermatology pharma companies, pursuing clinical trials for expanded indications, and protecting key formulations through new patents are key strategies.


Sources

[1] Transparency Market Research, "Wound Care Market," 2022.

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