You're using a free limited version of DrugPatentWatch: Upgrade for Complete Access

Last Updated: December 18, 2025

Leo Labs Company Profile


✉ Email this page to a colleague

« Back to Dashboard


Summary for Leo Labs
International Patents:31
US Patents:12
Tradenames:1
Ingredients:1
NDAs:1

Drugs and US Patents for Leo Labs

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 DISCN Yes No 9,833,429 ⤷  Get Started Free Y ⤷  Get Started Free
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 DISCN Yes No 9,833,428 ⤷  Get Started Free Y ⤷  Get Started Free
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No 8,372,828 ⤷  Get Started Free Y ⤷  Get Started Free
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 DISCN Yes No 8,735,375 ⤷  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

Expired US Patents for Leo Labs

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 6,787,161 ⤷  Get Started Free
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-001 Jan 23, 2012 6,432,452 ⤷  Get Started Free
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 6,844,013 ⤷  Get Started Free
Leo Labs PICATO ingenol mebutate GEL;TOPICAL 202833-002 Jan 23, 2012 7,410,656 ⤷  Get Started Free
>Applicant >Tradename >Generic Name >Dosage >NDA >Approval Date >Patent No. >Patent Expiration
Paragraph IV (Patent) Challenges for LEO LABS drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Gel 0.05% ➤ Subscribe 2016-01-27

Supplementary Protection Certificates for Leo Labs Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
1988877 2014C/045 Belgium ⤷  Get Started Free PRODUCT NAME: MEBUTATE D'INGENOL OU L'UN DE SES DERIVES (SELS OU ESTER); AUTHORISATION NUMBER AND DATE: EU/1/12/796 20121119
1988877 CA 2014 00042 Denmark ⤷  Get Started Free PRODUCT NAME: INGENOLMEBUTAT ELLER ET DERIVAT (SALT ELLER ESTER) DERAF); REG. NO/DATE: EU/1/12/796/001-002 20121119
1988877 C20140025 00111 Estonia ⤷  Get Started Free PRODUCT NAME: INGENOOLMEBUTAAT;REG NO/DATE: K(2012)8481 (LOPLIK) 19.11.2012
1988877 C201430051 Spain ⤷  Get Started Free PRODUCT NAME: INGENOL MEBUTATO O UN DERIVADO ESTER DEL MISMO.; NATIONAL AUTHORISATION NUMBER: EU/1/12/796; DATE OF AUTHORISATION: 20121115; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/12/796; DATE OF FIRST AUTHORISATION IN EEA: 20121115
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description
Similar Applicant Names
Applicants may be listed under multiple names.
Here is a list of applicants with similar names.

Pharmaceutical Competitive Landscape Analysis: Leo Labs – Market Position, Strengths & Strategic Insights

Last updated: July 29, 2025


Introduction

In the rapidly evolving pharmaceutical and biotechnological sectors, precision instrumentation and analytical services have become pivotal for advancing drug discovery, development, and manufacturing processes. Leo Labs, a pioneer in high-precision nanoparticle analysis, is increasingly influential within this landscape. This report explores Leo Labs’ market position, core strengths, and strategic outlook, providing critical insights for stakeholders aiming to navigate the competitive environment effectively.


Leo Labs’ Market Position

Emerging Leader in Nano-Particle Characterization

Leo Labs specializes in advanced nanoparticle size and concentration measurement technologies, primarily serving the pharmaceutical, biotech, and nanoparticle manufacturing industries. Its core offerings—such as the NanoCam system—deliver real-time, high-resolution analytics essential for ensuring compliance with stringent regulatory standards like those of the FDA and EMA.

Market Penetration and Client Base

The company’s rapid adoption by leading pharmaceutical firms underscores its rising prominence. Notably, Leo Labs actively collaborates with biotech startups, large pharmaceutical firms, and contract manufacturing organizations (CMOs). Its strategic positioning as a provider of both analytical tools and insights enables it to penetrate new segments swiftly.

Competitive Positioning vis-à-vis Peers

Compared to conventional particle analysis providers—such as Malvern Panalytical or Wyatt Technology—Leo Labs differentiates itself through its non-invasive, real-time measurement capability and the ability to analyze particles at nanometer scales with high throughput. This technological edge enhances its position amidst a landscape marked by traditional, often slower, bulk analysis techniques.


Core Strengths

1. Cutting-Edge Technology and Innovation

Leo Labs’ proprietary nano-imaging technology allows for precise, rapid characterization of nanoparticles at a scale unmatched by traditional methods. Its systems facilitate on-the-fly analysis, crucial for real-time decision-making during manufacturing and formulation stages.

2. Customizable and Scalable Solutions

Its modular platform design enables clients to tailor analytical workflows, integrating seamlessly into existing manufacturing lines. This scalability appeals to both early-stage R&D entities and large-scale production facilities, broadening the company’s market reach.

3. Strategic Collaborations and Industry Partnerships

Leo Labs’ collaborations with pharma giants and biotech startups generate valuable validation and foster trust. Such alliances often lead to co-development opportunities, further embedding its technology within industry standards.

4. Regulatory Compliance and Data Integrity

The company’s analytical systems meet key regulatory standards, which accelerates adoption by firms aiming for compliant manufacturing processes. The integration of audit trails and validated software enhances data integrity, a critical factor in pharmaceutical quality systems.

5. Thought Leadership and Market Education

Leo Labs actively participates in industry forums, publishes peer-reviewed studies, and shares technological advancements—positioning itself as a thought leader. This reputation enhances brand trust and influences market standards.


Strategic Insights

A. Expansion into New Therapeutic Areas

The rising importance of nanomedicine and targeted drug delivery offers new avenues. Leo Labs’ tools are increasingly relevant for characterizing drug delivery vehicles such as liposomes or polymeric nanoparticles, promising broader application territories.

B. Geographic Growth Strategies

While North America and Europe remain primary markets, emerging regions like Asia-Pacific show high growth potential. Targeted investments and local partnerships could accelerate market penetration, especially considering region-specific regulatory nuances.

C. Investment in Software Ecosystems

Developing integrated software platforms that facilitate data analytics, compliance reporting, and process monitoring enhances value propositions. Advanced AI-driven data interpretation could unlock further efficiencies and predictive insights.

D. Focus on Personalized Medicine

As personalized therapies gain prominence, the need for precise nanoparticle characterization grows. Leo Labs’ ability to provide robust, real-time data aligns with industry moves toward bespoke therapeutics, highlighting its strategic relevance.

E. Intellectual Property and R&D Investment

Continued investment in R&D and patent development ensures technological differentiation. Protecting core innovations maintains competitive barriers and allows for premium positioning.


Competitive Challenges and Risks

  • Technological Competition: Established analytical firms expanding into nanoparticle characterization pose a direct threat.
  • Regulatory Hurdles: Diverse global standards may complicate product compliance and deployment.
  • Market Education: Convincing conservative industries to adopt high-tech, real-time analysis systems involves educational challenges.
  • Pricing Pressures: As competition intensifies, pricing strategies may need optimization to maintain margins while expanding market share.

Conclusion

Leo Labs occupies a strategically advantageous position within the pharmaceutical analytical ecosystem, emphasizing technological innovation, regulatory compliance, and customer-centric solutions. Its focus on nanoparticle analysis caters directly to the burgeoning needs of nanomedicine and advanced drug delivery, positioning it for sustained growth. Key to its future success will be leveraging strategic collaborations, expanding geographically, and deepening technological capabilities to remain ahead of emerging competitors.


Key Takeaways

  • Leo Labs’ high-precision nanoparticle analysis technology differentiates it within a crowded market, enabling real-time, non-invasive measurements vital for pharmaceutical manufacturing.
  • Its strategic partnerships and focus on regulatory standards provide a competitive edge, fostering industry trust and expanding its client base.
  • Growth opportunities lie in diversification across therapeutic areas, regional expansion, and software integration for enhanced data analytics.
  • Protecting intellectual property and investing in R&D are critical to maintaining technological leadership amid evolving competition.
  • The industry shift towards personalized medicine and nanotechnology presents significant expansion potential for Leo Labs’ offerings.

FAQs

1. How does Leo Labs’ technology improve upon traditional nanoparticle analysis methods?
Leo Labs utilizes proprietary nano-imaging systems capable of real-time, high-resolution particle size and concentration analysis, offering faster, more accurate insights than traditional techniques like dynamic light scattering (DLS) or electron microscopy.

2. What industries benefit most from Leo Labs’ nanoparticle analysis solutions?
Primarily the pharmaceutical and biotech sectors, especially those involved in drug formulation, nanomedicine, vaccine development, and advanced delivery systems.

3. How does Leo Labs ensure regulatory compliance of its systems?
Its analytical platforms are designed with validated software, audit trails, and data security features aligned with international standards such as 21 CFR Part 11, facilitating regulatory approval and manufacturing compliance.

4. What are the main growth strategies for Leo Labs?
Expanding into new therapeutic areas like nanomedicine, increasing geographic footprint particularly in Asia-Pacific, and developing integrated data analytics platforms to enhance value delivery.

5. Who are Leo Labs’ main competitors, and how does it differentiate?
Competitors include Malvern Panalytical and Wyatt Technology. Leo Labs differentiates through its non-invasive, real-time nano-imaging technology and its focus on high throughput, which traditional methods often lack.


References
[1] Industry reports on nanoparticle analysis companies and market trends.
[2] Leo Labs official website and product literature.
[3] Regulatory standards applicable to pharmaceutical analytical systems.
[4] Market analyses on nanomedicine and personalized therapy growth projections.

More… ↓

⤷  Get Started Free

Make Better Decisions: Try a trial or see plans & pricing

Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. We do not provide individual investment advice. This service is not registered with any financial regulatory agency. The information we publish is educational only and based on our opinions plus our models. By using DrugPatentWatch you acknowledge that we do not provide personalized recommendations or advice. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.