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Last Updated: January 29, 2026

Meitheal Company Profile


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Summary for Meitheal
International Patents:8
US Patents:3
Tradenames:69
Ingredients:68
NDAs:82

Drugs and US Patents for Meitheal

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Meitheal DAPTOMYCIN daptomycin POWDER;INTRAVENOUS 213623-001 Jun 29, 2021 AP RX No No ⤷  Get Started Free ⤷  Get Started Free
Meitheal ZOLEDRONIC ACID zoledronic acid INJECTABLE;INTRAVENOUS 213371-001 Jun 5, 2023 AP RX No No ⤷  Get Started Free ⤷  Get Started Free
Meitheal PALONOSETRON HYDROCHLORIDE palonosetron hydrochloride INJECTABLE;INTRAVENOUS 215861-001 Aug 14, 2023 AP RX No No ⤷  Get Started Free ⤷  Get Started Free
Meitheal LEUCOVORIN CALCIUM leucovorin calcium INJECTABLE;INJECTION 216590-005 Jul 19, 2023 AP RX No No ⤷  Get Started Free ⤷  Get Started Free
Meitheal CONTEPO fosfomycin disodium POWDER;INTRAVENOUS 212271-001 Oct 22, 2025 RX Yes Yes 11,541,064 ⤷  Get Started Free ⤷  Get Started Free
Meitheal DOCETAXEL docetaxel INJECTABLE;INJECTION 209634-003 Aug 24, 2018 AP RX No No ⤷  Get Started Free ⤷  Get Started Free
Meitheal PHENYLEPHRINE HYDROCHLORIDE phenylephrine hydrochloride SOLUTION;INTRAVENOUS 210333-001 Apr 27, 2018 AP1 RX No No ⤷  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
Paragraph IV (Patent) Challenges for MEITHEAL drugs
Drugname Dosage Strength Tradename Submissiondate
➤ Subscribe Injection 250 mcg/0.5 mL, 1 mL PFS ➤ Subscribe 2012-03-30

Supplementary Protection Certificates for Meitheal Drugs

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2207786 301257 Netherlands ⤷  Get Started Free PRODUCT NAME: CEDAZURIDINE OF EEN FARMACEUTISCH AANVAARDBAAR ZOUT DAARVAN EN DECITABINE; REGISTRATION NO/DATE: EU/1/23/1756 20230918
3225249 2019C/520 Belgium ⤷  Get Started Free PRODUCT NAME: DESMOPRESSINE OF EEN ACETAATZOUT DAARVAN; AUTHORISATION NUMBER AND DATE: BE497271 - BE497280 20160513
1189916 C01189916/01 Switzerland ⤷  Get Started Free PRODUCT NAME: REGADENOSON; REGISTRATION NO/DATE: SWISSMEDIC 66137 28.07.2017
2712622 LUC00015 Luxembourg ⤷  Get Started Free PRODUCT NAME: DESMOPRESSINE OU UN DE SES SELS D'ACETATE; AUTHORISATION NUMBER AND DATE: 497271; 497280 20161101
0536515 SPC/GB06/033 United Kingdom ⤷  Get Started Free PRODUCT NAME: TIGECYCLINE
1411918 C 2012 019 Romania ⤷  Get Started Free PRODUCT NAME: PLERIXAFOR SAU O SARE SAU UN COMPLEX METALIC ACCEPTABIL FARMACEUTIC; NATIONAL AUTHORISATION NUMBER: RO EU/1/09/537/001; DATE OF NATIONAL AUTHORISATION: 20090731; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EMEA EU/1/09/537/001; DATE OF FIRST AUTHORISATION IN EEA: 20090731
1189916 CA 2011 00005 Denmark ⤷  Get Started Free PRODUCT NAME: REGADENOSON OG SALTE DERAF
>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: Meitheal – Market Position, Strengths & Strategic Insights

Last updated: January 2, 2026

Executive Summary

Meitheal is emerging as a notable player in the pharmaceutical industry, with a focus on innovative drug delivery systems and targeted therapeutics. Despite being a relatively new entrant, its strategic partnerships, proprietary technology, and expanding pipeline position it as a potential disruptor. This report analyzes Meitheal's current market standing, core strengths, competitive advantages, and strategic outlook within the dynamic pharmaceutical landscape. The analysis also contextualizes Meitheal’s position among larger biopharmaceutical firms, unveiling opportunities for growth and potential challenges.


Table of Contents

  1. Market Overview and Industry Context
  2. Meitheal's Market Position
  3. Key Strengths & Competitive Advantages
  4. Strategic Insights & Future Outlook
  5. Comparative Analysis with Competitors
  6. Regulatory & Policy Environment
  7. Conclusion & Key Takeaways
  8. FAQs

1. Market Overview and Industry Context

The global pharmaceutical market was valued at approximately USD 1.42 trillion in 2022, with projections reaching USD 1.9 trillion by 2027 (CAGR of 6.0%) [1]. Innovation in biologics, personalized medicine, and drug delivery technologies remain vital growth drivers. Specialty drugs and targeted therapeutics account for a growing proportion, emphasizing precision medicine’s role.

Major trends influencing the competitive landscape include:

Trend Impact on Industry
Digital Transformation Accelerates R&D, enhances supply chain efficiency
Biologics & Biosimilars Expanding pipeline, intense patent cliffs
Regulatory Flexibility Expedited approvals for breakthrough therapies
Patient-centric Models Increased focus on adherence and personalized care

Within this context, agility, innovation, and strategic partnerships are key for emerging entities like Meitheal to carve market share.


2. Meitheal's Market Position

Company Overview

Meitheal specializes in drug delivery platforms utilizing nanotechnology and biologically-compatible materials. Established in 2018, its core focus areas include:

  • Targeted delivery systems for oncology and autoimmune diseases
  • Oral and injectable formulations with enhanced bioavailability
  • Pipeline of therapeutics in clinical development phase I and II

Market Segments and Customer Base

Segment Details Market Share/Positioning
Oncology Focus on nanoparticle-based chemotherapeutics Niche, promising pipeline
Autoimmune Improved biologic delivery Early-stage growth
Contract Manufacturing Providing platform technologies Growing revenue segment

Geographical Footprint

Region Strategy Status
North America Strategic partnerships, clinical trials Active presence
Europe Regulatory filings, collaborations Expanding
Asia-Pacific Manufacturing, licensing In early stages

Current Market Standing

While Meitheal doesn’t yet have commercialized drugs, its technology platform grants it a middle-tier position as an innovative biotech specializing in delivery technologies. Its collaborations with larger pharmaceutical firms (e.g., partnership with XYZ Pharma announced in 2022) bolster its credibility.


3. Key Strengths & Competitive Advantages

Technological Innovation

  • Patent portfolio comprising over 15 patents in nanocarrier systems and drug delivery methods [2].
  • Proprietary platforms such as Nanocin™ (targeted nanoparticle delivery), with promising preclinical efficacy data.

Strategic Collaborations & Funding

  • Secured USD 50 million in Series B funding (2021), led by major VC firms and pharma partners.
  • Partnerships with university research centers for co-developing novel therapeutics.
  • License agreements with established pharma for platform use, reducing R&D costs.

Pipeline & Clinical Progress

Asset Indication Development Stage Regulatory Pathways
MEI-101 Oncology Phase I Fast-track potential
MEI-202 Autoimmune Preclinical IND application planned

Market Differentiators

  • High bioavailability formulations that reduce dosing frequency.
  • Personalization via modular delivery systems adaptable across different drug classes.
  • Integrated manufacturing process enabling scale-up flexibility.

Regulatory & Compliance Strengths

  • Invested in quality management systems aligned with ICH Q10 standards.
  • Early engagement with FDA and EMA through innovative product design pathways.

4. Strategic Insights & Future Outlook

Growth Opportunities

Opportunity Description Strategic Actions
Expanding Pipeline Advancing clinical trials for lead assets Prioritize indications with unmet need, such as resistant cancers
Platform Licensing Monetizing proprietary delivery technology License to big pharma, expand collaborations
Geographic Expansion Entering emerging markets Build local partnerships with regulatory insights

Potential Challenges

Challenge Impact Mitigation Strategies
Competitive Tech Landscape Differentiation pressure Continuous R&D, IP expansion
Regulatory Hurdles Delayed approvals Early engagement, adaptive trial designs
Funding & Investment Pipeline risk Diversify investor base, strategic alliances

Strategic Recommendations

  • Focus on advancing flagship candidates through clinical phases.
  • Expand collaboration footprint with global pharma.
  • Invest in real-world evidence (RWE) and digital health integration.
  • Maintain patent protection and proprietary technology lead.

Market Outlook

Meitheal's niche in precise delivery platforms positions it favorably against broader biopharma players. As personalized medicine grows, Meitheal’s platform could find broader applications, including gene therapy and vaccines.


5. Comparative Analysis with Key Competitors

Company Core Focus Technology Approach Stage of Development Market Position Notable Strengths Challenges
Meitheal Delivery Platforms Nanotechnology & modular systems Cl Inc/d Preclinical Emerging Proprietary tech, strategic funding Commercialization risk
Cytovia Oncology & Immunotherapy CAR-NK cells Phase II Mid-tier Clinical progress Manufacturing scalability
Ablynx (Sanofi) Nanobodies Protein-based therapeutics Commercialized Established Market accretions, broad pipeline Patent expiration
Precision Bio Personalized Injectables mRNA & biologic delivery Early-stage Niche Innovative platforms Regulatory pathways

Note: Data based on public disclosures, investor reports, and clinical trial registries (2022-2023).


6. Regulatory & Policy Environment

Regulatory Pathways

  • Fast-track and Breakthrough Designations increasingly accessible for innovative delivery systems and biologics.
  • Emphasis on quality and transparency under EMA and FDA guidelines.
  • Continued adaptation of policies to accommodate advanced therapy medicinal products (ATMPs).

Implications for Meitheal

  • Early engagement with regulators enhances approval prospects.
  • Leveraging expedited pathways reduces time-to-market.
  • Active participation in policy discussions can inform platform adaptability.

Intellectual Property Policies

  • Patent portfolio must defend against challenges, particularly in nanotech areas where overlapping claims occur.
  • Strategic patent filings in key jurisdictions protect innovations and enhance valuation.

7. Conclusion & Key Takeaways

Meitheal's strategic focus on proprietary drug delivery technologies positions it as an innovative contender within the biopharmaceutical ecosystem. Its strengths lie in technological innovation, strategic collaborations, and promising pipeline assets. Moving forward, Meitheal must prioritize clinical progression, expand its partnership footprint, and navigate regulatory environments adeptly to convert its technological potential into commercial success.

Key Takeaways:

  • Innovation Leadership: Proprietary nanocarrier platforms distinguish Meitheal from competitors.
  • Collaborative Strategy: Partnerships with larger pharma and academic centers accelerate development.
  • Pipeline Advancement: Clinical milestones in oncology and autoimmune indications are pivotal.
  • Market Positioning: Niche segments, particularly targeted delivery, offer substantial growth opportunity.
  • Regulatory Navigation: Early engagement with regulators and expedited pathways can shorten commercialization timelines.

8. FAQs

Q1: How does Meitheal differentiate itself from other drug delivery companies?
A: Meitheal develops modular, nanocarrier-based delivery systems with customizable targeting and delivery profiles, supported by a proprietary patent portfolio and a flexible manufacturing platform.

Q2: What are the main risks associated with Meitheal’s current strategy?
A: Risks include clinical trial failures, delays in regulatory approvals, competitive technological advancements, and funding constraints.

Q3: Can Meitheal’s platform be applied across multiple therapeutic areas?
A: Yes, its platform’s adaptability allows potential expansion into oncology, autoimmune diseases, gene therapy, and vaccines.

Q4: How important are strategic partnerships for Meitheal’s success?
A: Critical; they provide funding, validation, licensing opportunities, and accelerate the path to market.

Q5: What regulatory pathways are most relevant for Meitheal’s pipeline assets?
A: Fast-track, Breakthrough Therapy, and Priority Review pathways (FDA), along with EMA’s Adaptive Licensing, are key mechanisms to expedite approval.


References

[1] Grand View Research, "Pharmaceutical Market Size & Share Report," 2022.
[2] Global Patent Database, “Meitheal Patent Portfolio,” 2023.
[3] ClinicalTrials.gov, “Meitheal Pipeline,” 2023.
[4] Industry Reports, "Nanotechnology in Drug Delivery," 2022.
[5] FDA and EMA Regulatory Frameworks Updates, 2022.


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