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Last Updated: January 5, 2025

SANTYL Drug Profile


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Recent Clinical Trials for SANTYL

Identify potential brand extensions & biosimilar entrants

SponsorPhase
Derma Sciences, Inc.N/A
Integra LifeSciences CorporationN/A
University of MiamiPhase 1

See all SANTYL clinical trials

Recent Litigation for SANTYL

Identify key patents and potential future biosimilar entrants

District Court Litigation
Case NameDate
Apple Inc. v. ITC2023-12-26
SoftWave Tissue Regeneration Technologies, LLC v. Dr. Har Hari S. Khalsa, DC2022-10-26
Apple Inc. v. Masimo Corporation2022-10-20

See all SANTYL litigation

PTAB Litigation
PetitionerDate
2020-01-28
2018-07-17
Avita Medical Limited2017-04-04

See all SANTYL litigation

Pharmacology for SANTYL
Ingredient-typeCollagenases
Established Pharmacologic ClassCollagen-specific Enzyme
Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

  1. Brand-side disclosures in response to biosimilar applications
  2. These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

  3. General brand-side disclosures
  4. These patents were identified from searching drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

  5. Patents from broad patent text search
  6. For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for SANTYL Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for SANTYL Derived from Company Disclosures

No patents found based on company disclosures

3) Low Certainty: US Patents for SANTYL Derived from Patent Text Search

These patents were obtained by searching patent claims

SANTYL Market Analysis and Financial Projection

Market Dynamics and Financial Trajectory for SANTYL

Introduction

SANTYL, a collagenase ointment, has been a market leader in enzymatic debridement for chronic dermal ulcers and severely burned areas. Here, we delve into the current market dynamics and the financial trajectory of SANTYL, considering recent developments and competitive pressures.

Market Leadership and Sales Performance

SANTYL, developed by Smith & Nephew, is the only FDA-approved enzymatic debrider and has dominated the market with estimated annual sales of over $360 million in the United States[1][4].

Clinical Efficacy and Benefits

Clinical studies have consistently shown that SANTYL promotes faster rates of granulation and epithelialization in wound healing. For example, a retrospective study involving 787 patients demonstrated that SANTYL treatment was 38% more likely to achieve 100% granulation and 47% more likely to achieve epithelialization compared to medicinal honey treatment[4].

Competitive Landscape

The competitive landscape for SANTYL is undergoing significant changes with the emergence of new products. MediWound's EscharEx, a bromelain-based gel, has shown superior results in debridement efficiency, promotion of granulation tissue, and speed to wound closure compared to SANTYL in head-to-head studies. This could potentially disrupt the current market dynamics and challenge SANTYL's market leadership[1].

Financial Impact of Competitive Pressure

The potential market shift towards EscharEx, should it receive FDA approval, could significantly impact SANTYL's sales and market share. This could lead to a competitive response from Smith & Nephew, including price adjustments, increased marketing expenditures, and investments in research and development to maintain or grow market share[1].

Quarterly and Annual Financial Performance

Smith & Nephew's financial reports indicate that while the company has seen overall revenue growth, the Advanced Wound Management segment, which includes SANTYL, has experienced some volatility. In the first quarter of 2024, Advanced Wound Management revenue declined by 2.0% on an underlying basis, partly due to expected SANTYL volatility following a strong finish to 2023[3].

Revenue Growth and Market Segments

Despite the decline in Advanced Wound Bioactives, which includes SANTYL, Smith & Nephew's overall revenue has shown growth. The company reported a full-year revenue of $5,549 million in 2023, up 7.2% on an underlying basis. The Advanced Wound Management segment, however, faces challenges, including a decline in the first quarter of 2024, which was offset by growth in other segments like Orthopaedics and Sports Medicine & ENT[2][3].

Strategic Initiatives and Outlook

Smith & Nephew's 12-Point Plan, aimed at transforming the company, is on track and has started to translate into financial outcomes. The company is focusing on innovation, product launches, and improving customer satisfaction. Despite the challenges in Advanced Wound Management, the overall outlook remains positive, with expected underlying revenue growth in the range of 5.0% to 6.0% for 2024[2][3].

Impact on Healthcare Costs

SANTYL's efficacy in reducing the overall cost of treating chronic wounds is well-documented. However, the emergence of EscharEx could further optimize wound care costs by reducing the duration of treatment and associated expenses. Faster healing times and the reduction of biofilm and bioburden could lead to fewer complications and secondary interventions, benefiting both patients and the healthcare system economically[1].

Regulatory and Clinical Trials

The ongoing clinical trials and regulatory approvals will be crucial in determining the long-term market dynamics. EscharEx's upcoming Phase III trial will be pivotal in validating its superiority over SANTYL. Meanwhile, SANTYL's established presence and clinical evidence will continue to support its use as a first-line debridement agent[1][4].

Market Penetration Strategies

To maintain market share, Smith & Nephew may need to employ aggressive market penetration strategies. This could include enhancing marketing efforts, offering competitive pricing, and investing in further research to improve SANTYL's efficacy or develop new products that can compete with emerging alternatives like EscharEx[1].

Conclusion

SANTYL remains a significant player in the enzymatic debridement market, but its dominance is being challenged by new entrants like EscharEx. The financial trajectory of SANTYL will depend on how effectively Smith & Nephew responds to these competitive pressures and how the market adapts to new clinical evidence and regulatory approvals.

Key Takeaways

  • Market Leadership: SANTYL is the current market leader in enzymatic debridement with substantial sales.
  • Competitive Pressure: EscharEx has shown superiority in clinical trials, potentially disrupting SANTYL's market share.
  • Financial Performance: Smith & Nephew's overall revenue growth is offset by volatility in the Advanced Wound Management segment.
  • Strategic Initiatives: The company's 12-Point Plan and innovation strategy are driving growth and improving financial outcomes.
  • Healthcare Costs: Effective wound care products like SANTYL and EscharEx can reduce healthcare costs by promoting faster healing times.
  • Regulatory and Clinical Trials: Ongoing trials and approvals will determine the long-term market dynamics.

FAQs

Q: What is SANTYL used for? A: SANTYL is used for debriding chronic dermal ulcers and severely burned areas. It is the only FDA-approved enzymatic debrider.

Q: How does SANTYL compare to EscharEx in clinical trials? A: EscharEx has shown superior results in debridement efficiency, promotion of granulation tissue, and speed to wound closure compared to SANTYL in head-to-head studies.

Q: What is the current market size of SANTYL? A: SANTYL has estimated annual sales of over $360 million in the United States.

Q: How might Smith & Nephew respond to the competitive pressure from EscharEx? A: Smith & Nephew may employ strategies such as price adjustments, increased marketing, and investments in research and development to maintain market share.

Q: What are the broader financial implications for Smith & Nephew? A: The company's overall revenue growth and financial performance could be impacted by the decline in Advanced Wound Management segment sales, but other segments like Orthopaedics and Sports Medicine & ENT are showing strong growth.

Sources

  1. MediWound Announces Positive Results in Head-to-Head Comparison of EscharEx vs. SANTYL - Stock Titan
  2. Smith+Nephew Fourth Quarter and Full Year 2023 Results - Smith+Nephew
  3. Smith+Nephew First Quarter 2024 Trading Update - Smith+Nephew
  4. Smith & Nephew Inc. Release: Collagenase SANTYL Ointment Advances Pressure Ulcers Through the Healing Process Faster - BioSpace

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