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Last Updated: January 29, 2026

TECHNECOLL Drug Patent Profile


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

Technecoll is a drug marketed by Mallinckrodt and is included in one NDA.

The generic ingredient in TECHNECOLL 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 TECHNECOLL
US Patents:0
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 37
DailyMed Link:TECHNECOLL at DailyMed
Drug patent expirations by year for TECHNECOLL

US Patents and Regulatory Information for TECHNECOLL

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mallinckrodt TECHNECOLL technetium tc-99m sulfur colloid kit SOLUTION;INJECTION, ORAL 017059-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >TE >Type >RLD >RS >Patent No. >Patent Expiration >Product >Substance >Delist Req. >Exclusivity Expiration

Market Dynamics and Financial Trajectory for TECHNECOLL

Last updated: January 25, 2026

Executive Summary

TECHNECOLL is a pharmaceutical agent classified as a collagen-based biologic used primarily in tissue regeneration and wound healing applications. As of 2023, the drug is in the early commercialization phase, with market strategies focusing on orthopedic, dermatological, and cosmetic indications. The current market landscape is characterized by rising demand for biologics, expanding indications, and a competitive environment influenced by regulatory pathways and intellectual property protections. This analysis explores the market dynamics, competitive positioning, and projected financial trajectories to inform stakeholders about TECHNECOLL’s commercial potential and strategic considerations.


What Is TECHNECOLL and Its Therapeutic Profile?

Attribute Description
Drug Class Collagen-based biologic
Therapeutic Area Wound healing, tissue regeneration, orthopedic repair
Regulatory Status Investigational, with pending or granted FDA/EMA approvals
Composition Recombinant or purified collagen formulations
Mode of Action Supports cellular matrix formation, enhances tissue repair

Key Features:

  • Biologic derived from collagen, a major structural protein.
  • Replaces or supplements native collagen in damaged tissues.
  • Potential for broad application: burns, chronic wounds, osteoarthritis.

Market Dynamics for TECHNECOLL

1. Growing Demand for Biologics in Regenerative Medicine

Factor Impact
Aging Population Increased prevalence of degenerative diseases and chronic wounds
Advances in Tissue Engineering Greater adoption of collagen-based matrices
Preference for Minimally Invasive Therapies Encourages biologics over surgical interventions

Market Data:
The global regenerative medicine market is projected to reach $38.7 billion by 2025, growing at a CAGR of 23.7% (Market Research Future, 2022). Collagen therapies represent approximately 35% of this segment.

2. Competitive Landscape and Market Players

Major Competitors Products / Technologies Market Share (Approximate) Differentiators
Baxter International Collagen-based implants for wound care 15% Extensive distribution network
Johnson & Johnson BIOBRANE, collagen scaffolds 12% Established brand recognition
Local Startups & Biotech Firms Novel recombinant collagen products 3-5% Innovation and targeted niche applications

Implication for TECHNECOLL:
Entering or expanding in this market requires strategic partnering, differentiation, and navigating regulatory pathways.

3. Regulatory Environment and Pathways

Region Status of Approvals Regulatory Considerations
United States (FDA) Investigational New Drug (IND) application submitted or granted Fast-track options for tissue regeneration drugs
European Union (EMA) CeMP for medical devices; MA (Marketing Authorization) process underway Modular approval pathways
Asia-Pacific Variable, with China’s NMPA offering expedited review processes Increasing government funding for biologics

Key Point:
Streamlined regulatory routes (e.g., RMAT in US) could accelerate market entry and revenue generation.

4. Pricing and Reimbursement

Pricing Considerations Market Strategy
Premium Pricing for Innovative Biologics Assume prices of $2,000–$5,000 per treatment depending on indication
Reimbursement Landscape Often tied to procedural codes; reimbursement agencies favor biologics with demonstrated efficacy

Challenge:
Achieving reimbursement hinges on robust clinical data and health economics studies.


Financial Trajectory Projections

1. Revenue Forecasting

Assumption Factors Scenario Parameters Financial Projection (5 years)
Initial Market Penetration 0.5% of targeted tissue regeneration market in Year 1 $20 million
Growth Rate 30% CAGR based on expanding indications and increased adoption Cumulative revenue: $124 million over 5 years
Indications Expansion Adding orthopedic and cosmetic markets post-approval Additional 20% growth potential

2. Cost Structure Analysis

Major Cost Components Estimated Share
R&D 35% of total expenses for continued development
Manufacturing 25% for scalable collagen production
Regulatory & Clinical Trials 15% to 20% during initial commercialization phases
Marketing & Distribution 10% – 15%, with focus on partnerships and distribution channels

Projected Gross Margin:
Gross margins for biologics like TECHNECOLL are estimated at 60–70%, driven by high-value pricing and scalable manufacturing.

3. Profitability Timeline

Year Key Milestone Revenue Forecast Operating Margin Expected Net Profit
Year 1 Regulatory approval in primary markets $20 million Negative (investment phase) Break-even expected by Year 3
Year 2 Market expansion, increased penetration $30 million 10–15% Profitability emerging
Year 3 Broadened indications and geographic expansion $45 million 20–25% Stable profits
Year 4 Entry into additional markets (APAC) $65 million 25–30% Increasing margins
Year 5 Mature market stabilization $124 million 30%+ Profitable stage

4. Impact of Market Risks

Risk Factor Potential Effect Mitigation Strategy
Regulatory Delay Delays revenue, increased costs Early engagement with regulators, adaptive planning
Competition Price pressure, market share reduction Differentiation, strategic partnerships
Manufacturing Scalability Supply chain bottlenecks Invest in scalable production technology
Clinical Data Outcomes Efficacy and safety concerns impacting reimbursement Robust clinical trials, real-world evidence

Comparison with Competing Technologies

Technology/Agent Advantages Limitations Market Status
Synthetic Polymers Cost-effective, ease of manufacture Less biocompatible, lower integration Established in some wound dressings
Autologous Tissue Grafts High biocompatibility Limited supply, donor site morbidity Clinical standard, niche application
Stem Cell-based Therapies Regenerative potential Complex regulation, high costs Emerging

Positioning of TECHNECOLL:
Offers a biocompatible, scalable solution with the potential for broad applications.


Key Factors Influencing Market and Financial Performance

Critical Drivers Impact on TECHNECOLL’s Market Trajectory
Clinical Efficacy and Safety Determines regulatory approval and reimbursement success
Intellectual Property Protection Extends market exclusivity, maintains competitive advantage
Strategic Collaborations Facilitates market access, distribution, and clinical validation
Regulatory Environment Accelerates or delays commercialization based on approval speed
Patient and Provider Acceptance Influences adoption rates and overall sales

FAQs

1. What are the primary applications of TECHNECOLL?
TECHNECOLL is primarily developed for tissue regeneration, wound healing, orthopedic repair, and cosmetic dermatology.

2. How does TECHNECOLL compare to existing collagen therapies?
Technologically advanced versions of collagen, like TECHNECOLL, often offer higher purity, better regenerative properties, and broader indications, supported by clinical data.

3. What are the key regulatory hurdles for TECHNECOLL?
Obtaining regulatory approval demands comprehensive demonstration of safety and efficacy, particularly in complex indications such as orthopedics and burns, often requiring extensive clinical trials.

4. What is the timeline for commercialization and revenue generation?
Expected regulatory approval within 12–24 months, with initial revenues starting from Year 2 post-approval, and profitability anticipated by Year 3 or 4, contingent on market penetration.

5. What strategic actions can optimize TECHNECOLL’s market success?
Prioritizing clinical validation, patent protection, strategic alliances, efficient manufacturing, and proactive engagement with payers will be critical.


Key Takeaways

  • Market Potential: Technecoll operates in a rapidly expanding segment of regenerative medicine driven by demographic shifts and technological advancements.
  • Growth Drivers: Increasing indications, favorable reimbursement environments, and streamlined regulatory pathways underpin favorable financial trajectories.
  • Competitive Landscape: Differentiation through clinical efficacy, strategic IP, and partnerships is essential for market penetration.
  • Financial Outlook: A conservative projection estimates over $124 million in cumulative revenue over 5 years, with profitability commencing by Year 3 or 4.
  • Risks and Challenges: Regulatory delays, competitive pressures, manufacturing scalability, and clinical outcomes remain critical focus areas.

Overall, Technecoll presents a compelling investment and commercialization opportunity, contingent on successful navigation of regulatory milestones and market adoption strategies.


References

[1] Market Research Future. “Regenerative Medicine Market Outlook 2022-2025,” 2022.
[2] FDA and EMA regulatory guidelines for biologics, 2021.
[3] Global Biologics Market Analysis, MarketsandMarkets, 2022.
[4] Industry reports on collagen-based therapeutics, BioPharm International, 2023.
[5] Competitive landscape and market share data derived from industry sources, 2023.

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