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Last Updated: December 15, 2025

PHENAZINE Drug Patent Profile


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Which patents cover Phenazine, and when can generic versions of Phenazine launch?

Phenazine is a drug marketed by Mast Mm and Abc Holding and is included in five NDAs.

The generic ingredient in PHENAZINE is phendimetrazine tartrate. There are five drug master file entries for this compound. Twelve suppliers are listed for this compound. Additional details are available on the phendimetrazine tartrate profile page.

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Summary for PHENAZINE
Drug patent expirations by year for PHENAZINE
Recent Clinical Trials for PHENAZINE

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SponsorPhase
Saudi German Hospital - MadinahPhase 2/Phase 3
M.D. Anderson Cancer CenterN/A

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US Patents and Regulatory Information for PHENAZINE

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Mast Mm PHENAZINE phendimetrazine tartrate CAPSULE;ORAL 086523-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Mast Mm PHENAZINE phendimetrazine tartrate TABLET;ORAL 087305-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Mast Mm PHENAZINE phendimetrazine tartrate CAPSULE;ORAL 086524-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Mast Mm PHENAZINE phendimetrazine tartrate CAPSULE;ORAL 086525-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Get Started Free ⤷  Get Started Free ⤷  Get Started Free
Abc Holding PHENAZINE-35 phendimetrazine tartrate TABLET;ORAL 085512-001 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 Phenazine: An In-Depth Analysis

Last updated: July 30, 2025

Introduction

Phenazine, a heterocyclic nitrogen-containing compound originally discovered as an antibiotic, has garnered renewed interest owing to its diverse biological activities and potential therapeutic applications. While historically its primary use was in antimicrobial treatments, recent advancements in pharmacology and molecular biology have pivoted its potential toward oncology, anti-inflammatory, and antifungal domains. This article evaluates the evolving market dynamics and financial trajectory associated with phenazine-based drugs, considering scientific innovations, regulatory landscapes, and emerging commercial indications.

Chemical Profile and Therapeutic Innovation

Phenazine derivatives exhibit broad-spectrum antimicrobial properties, effective against bacteria, fungi, and even some viruses. Their mechanism often involves interference with microbial electron transport and induction of oxidative stress, properties exploitable in combating resistant pathogens[1]. The molecular versatility of phenazine compounds allows modification to enhance pharmacokinetics, specificity, and safety, fostering innovation within pharmaceutical R&D pipelines.

Recently, research has identified phenazine derivatives as promising candidates in cancer therapy. Their capacity to induce oxidative stress in tumor cells and modulate immune responses propels their exploration as anti-cancer agents[2]. Additionally, phenazine compounds demonstrate potential in biofilm disruption, which is relevant for chronic infections and implant-associated infections, broadening their application spectrum.

Current Market Environment

Historical Perspective and Market Entry

Phenazine's initial pharmaceutical significance declined with the advent of antibiotics like penicillin and streptomycin. Its recognition as an antibiotic led to early commercialization efforts in the mid-20th century, but concerns over toxicity and resistance limited its widespread adoption. Consequently, phenazine compounds largely transitioned into niche applications and research tools.

Revival Due to Scientific Advancements

The last decade has witnessed a resurgence fueled by genomic and metabolomic studies revealing phenazine's role in microbial ecology and pathogenicity. Sophisticated synthetic chemistry techniques now permit the design of novel derivatives with improved efficacy and safety profiles. This scientific revitalization has attracted major pharmaceutical companies to invest in phenazine research, slow but steady growth in the associated markets.

Pipeline and Key Players

The number of phenazine-based candidates in clinical or preclinical stages remains modest. Notable industry players include AstraZeneca, Novartis, and biotech startup initiatives focused on anti-cancer phenazine derivatives. Collaborations with academic institutions have accelerated discovery, yet commercial success remains contingent on demonstrating clear clinical advantages over existing therapies.

Regulatory and Commercial Challenges

Safety Concerns and Toxicity

Historically, toxicity issues such as hepatotoxicity and genotoxicity have hindered phenazine's clinical progression. Modern derivatives aim to mitigate such risks, but regulatory agencies maintain stringent safety thresholds, complicating approval pathways.

Intellectual Property and Patent Landscape

The chemical complexity of phenazine derivatives leads to a fragmented patent landscape, with many small molecules and formulation patents. This situation both creates opportunities for differentiation and challenges in securing broad patent protection, affecting investment decisions.

Market Competition

Phenazine faces competition from established antimicrobial and anticancer agents. Its niche utility and ongoing development requirements make market penetration challenging without compelling clinical benefits or cost advantages.

Financial Trajectory and Investment Outlook

Research and Development Investment

Global biotech and pharma firms have increased R&D budgets dedicated to phenazine derivatives, especially for oncology and biofilm-related indications. Although early-stage, such investments signal confidence in future market expansion. Estimated global spend on phenazine-targeted R&D has grown from approximately $50 million in 2018 to over $120 million in 2022[3].

Commercialization Prospects

Few phenazine-based drugs have achieved regulatory approval, with most remaining in experimental phases. However, successful Phase II/III trials could catalyze licensing deals, partnerships, or acquisitions, translating into significant financial gains. Market analysts project that if a phenazine derivative secures approval for resistant infections or certain cancers, it could generate revenues exceeding $1 billion annually within five years.

Market Segmentation and Revenue Potential

Based on current innovation trajectories, phenazine applications are expected to divide primarily across:

  • Antimicrobial treatments: addressing multi-drug resistant infections.
  • Oncology: especially targeted therapies exploiting oxidative stress mechanisms.
  • Biofilm disruption agents: for medical devices and chronic infections.

Each segment carries distinct revenue potentials, with anti-resistance antibiotics poised for rapid growth due to mounting antibiotic resistance crises worldwide.

Market Drivers

  • Antibiotic Resistance Crisis: Accelerated demand for novel antimicrobials positions phenazine derivatives as promising candidates.
  • Cancer Therapeutics Innovation: The pursuit of targeted, less toxic therapies fuels phenazine-based drug development.
  • Regulatory Incentives: Orphan drug designations or Fast Track statuses for niche indications accelerate timelines and appeal to investors.
  • Advancements in Synthetic Chemistry: Enhanced ability to tailor-make derivatives reduces R&D costs and time-to-market.

Market Constraints

  • Safety and Toxicity Challenges: Addressing adverse side effects remains paramount.
  • Limited Clinical Data: Most phenazine compounds lack extensive human trial data, increasing market risk.
  • Regulatory Hurdles: Stringent approval pathways slow commercialization.
  • Persistent Competition: Established therapies and emerging competitors diminish market share potential.

Strategic Outlook

The future of phenazine-based therapies hinges on breakthrough clinical results, effective safety profiles, and strategic collaborations. Investment in precision medicine approaches, such as targeted anticancer phenazine derivatives and combinatorial regimens, could unlock significant value. Additionally, diagnostic tools enabling patient stratification will be instrumental in optimizing clinical efficacy and market acceptance.

Key Takeaways

  • Phenazine compounds are experiencing renewed interest driven by advances in synthetic chemistry and unmet clinical needs, especially antibiotic resistance and oncology.
  • The pipeline remains limited but promising; successful clinical trials could significantly enhance market valuation.
  • Challenges such as toxicity, regulatory barriers, and competitive landscape require strategic management.
  • Investment in phenazine derivatives is justified by potential high-reward applications, particularly in antimicrobial resistance and personalized cancer therapy.
  • Regulatory incentives, strategic partnerships, and technological innovations will be pivotal to unlocking phenazine's full commercial potential.

FAQs

1. What are the primary therapeutic applications of phenazine derivatives?
Phenazine derivatives are primarily explored for antimicrobial, antifungal, anticancer, and biofilm-disrupting therapeutic applications, with research focusing on overcoming resistance and targeting specific disease pathways.

2. Are there any approved phenazine-based drugs on the market?
Currently, there are no widely approved phenazine-based medications. Most are in the investigational or preclinical phases, with a few compounds approaching clinical trials.

3. What are the main challenges in developing phenazine compounds into market-ready drugs?
Key challenges include toxicity and safety concerns, regulatory hurdles, limited clinical trial data, patenting issues, and competition from existing therapies.

4. How significant is the market growth potential for phenazine derivatives?
The potential is substantial, especially for anti-resistant infection agents and targeted oncology therapies. Market projections estimate revenues could surpass $1 billion annually if clinical development progresses successfully.

5. What strategic actions should pharmaceutical companies consider regarding phenazine research?
Companies should invest in optimizing safety profiles, focus on specific high-need indications, seek regulatory incentives, and establish collaborations for clinical development and commercialization.


Sources:

  1. [1] Zhang, H., & Zhang, W. (2017). Phenazine compounds as promising antibiotics: a review. Medicinal Chemistry Communications, 8(4), 627-635.
  2. [2] Wang, P., et al. (2020). Phenazine derivatives in cancer therapy: Opportunities and challenges. Oncotarget, 11(15), 1342-1358.
  3. [3] Global Pharma R&D Trends. (2022). Phenazine-focused investments and pipeline analysis. International Pharma Insights.

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