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Evans blue - Generic Drug Details
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What are the generic drug sources for evans blue and what is the scope of patent protection?
Evans blue
is the generic ingredient in one branded drug marketed by Parke Davis and is included in one NDA. Additional information is available in the individual branded drug profile pages.Summary for evans blue
| US Patents: | 0 |
| Tradenames: | 1 |
| Applicants: | 1 |
| NDAs: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 47 |
| Patent Applications: | 6,926 |
| DailyMed Link: | evans blue at DailyMed |
Medical Subject Heading (MeSH) Categories for evans blue
US Patents and Regulatory Information for evans blue
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Parke Davis | EVANS BLUE | evans blue | INJECTABLE;INJECTION | 008041-001 | 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 the Pharmaceutical Drug: Evans Blue
Introduction
Evans blue, historically recognized as a dye with medical applications, is increasingly being evaluated for its potential role within the pharmaceutical landscape. Originally used as a diagnostic agent to evaluate vascular permeability, its unique binding properties to serum albumin have sparked renewed interest in drug delivery, imaging, and biomarker development. This article explores the evolving market dynamics and financial trajectory of Evans blue, emphasizing its transition from a diagnostic dye to a promising pharmaceutical asset.
Historical Background and Pharmacological Profile
Evans blue (also known as T-1824) has a longstanding history in medicine, primarily used in studies measuring edema and vascular permeability due to its affinity for serum albumin [1]. Its high affinity for albumin facilitates prolonged circulation, making it a useful tracer in various diagnostic procedures. However, its potential extends beyond diagnostics; recent research suggests applications in targeted drug delivery, cancer imaging, and treatment monitoring.
Despite its established use in research contexts, Evans blue's therapeutic relevance remains in early stages, with ongoing investigation into modifying its molecular structure to optimize pharmacokinetics and reduce toxicity. Its utility as a scaffold for controlled drug release can potentially unlock new revenue streams, positioning it within the broader pharmaceutical innovation ecosystem.
Current Market Landscape
Market Size and Segment Analysis
The direct market for Evans blue in its traditional dye form remains niche, limited primarily to academic research and diagnostic laboratories. The global diagnostic dye market, estimated at approximately \$1.2 billion in 2021, is mature with relatively slow growth [2]. Evans blue's role within this segment is constrained by its toxicity profile, restricting widespread clinical adoption.
However, its potential derivatives and formulations for drug delivery and imaging are emerging segments, collectively representing an untapped market. The targeted drug delivery market, valued at over \$1.5 billion in 2022, is driven by the need for precision therapies, especially in oncology and neurology [3].
Key Players and Patent Activity
Major pharmaceutical companies and biotech startups are beginning to file patents focused on Evans blue derivatives, conjugates, and formulations aimed at enhanced targeting and reduced toxicity. Notably, several patent filings in North America and Europe detail novel Evans blue-based conjugates for chemotherapy delivery [4].
Academic institutions and research organizations are also active, exploring Evans blue derivatives as probes for tumor imaging and vascular studies. The proliferation of patent activity signals increasing commercial interest and potential diversification of applications.
Market Drivers
1. Advances in Targeted Drug Delivery
The surge in precision medicine fosters demand for delivery vectors capable of delivering chemotherapeutic agents directly to tumor cells or specific tissues. Evans blue’s affinity for serum albumin makes it suitable as a carrier that can improve drug bioavailability, reduce systemic toxicity, and enhance therapeutic indices [5].
2. Imaging and Diagnostic Innovation
In molecular imaging, Evans blue’s properties enable it to serve as a contrast agent for vascular imaging and tumor visualization. Conjugation with imaging moieties like MRI or PET tracers could position Evans blue as an active component in next-generation imaging agents.
3. Increasing R&D Investment
Pharmaceutical companies are exploring Evans blue derivatives to develop novel therapeutics and diagnostics, fueling patent filings and preclinical studies. This sustained research momentum is poised to translate into market opportunities over the next decade.
4. Regulatory Landscape
While the toxicity profile presents challenges, advances in nanotechnology and molecular modification may reduce adverse effects, facilitating regulatory approval pathways for Evans blue-based therapeutics and diagnostics in major markets.
Market Challenges
1. Toxicity and Safety Concerns
The primary obstacle for Evans blue’s broader clinical adoption is its toxicity, notably its propensity to cause hypotension and allergic reactions at high doses [6]. Developing safer derivatives with minimized adverse effects remains a priority.
2. Limited Commercial Infrastructure
Currently, Evans blue is not produced at commercial scale for pharmaceutical purposes, requiring significant process development, validation, and regulatory compliance—factors that can delay market entry.
3. Competition from Alternative Agents
Other dyes and molecular carriers, such as indocyanine green and albumin-based nanoparticles, serve similar functions with established safety profiles, competing with Evans blue's emerging applications.
4. Regulatory Hurdles
Innovative therapeutics involving Evans blue derivatives must navigate rigorous clinical trial phases and regulatory approval, which entail substantial investments and timeframes.
Financial Trajectory and Investment Outlook
Preclinical and Clinical Investment
Investors and pharmaceutical developers are channeling capital into Evans blue derivative programs, especially those targeting oncology and imaging. The number of patent applications and university grants reflects a growing R&D pipeline, with several compounds entering preclinical evaluation stages.
Partnerships and Licensing
Collaborative development models—spanning biotech startups, academic institutions, and big pharma—are pivotal. Licensing agreements for Evans blue-based technology platforms have been reported, providing revenue streams via upfront payments and milestone-based royalties.
Market Revenue Projections
While a mature, standalone Evans blue dye market is unlikely to exceed \$50 million annually due to safety and competition issues, the derivatives and conjugates segment holds substantial promise. Projections suggest that Evans blue-based therapeutics and imaging agents could generate cumulative revenues exceeding \$1 billion by 2030, contingent upon successful clinical translation [7].
Funding Sources
Venture capital and government grants are significant sources of funding for early-stage Evans blue research. Additionally, strategic investments from pharmaceutical industry players aim to accelerate product development pipelines.
Strategic Opportunities
- Optimization of Safety Profiles: Focused chemical modification to reduce toxicity could accelerate clinical adoption.
- Expansion in Precision Medicine: Developing Evans blue conjugates targeting specific biomarkers for cancer and neurological disorders.
- Advancement in Imaging Modalities: Integration with novel imaging technologies offers multimodal diagnostic solutions.
- Infrastructural Development: Scaling manufacturing processes to meet regulatory standards and commercial demands.
Conclusion
Evans blue's transition from a diagnostic dye to a multifunctional pharmaceutical platform exemplifies the dynamic landscape of drug delivery and imaging innovation. While traditional applications face market limitations due to safety concerns, strategic chemical modifications and targeted development efforts could unlock significant value. The current research momentum and patent activity indicate robust interest, underscoring a promising financial trajectory over the coming decade.
Key Takeaways
- The traditional Evans blue market remains niche, but derivatives for drug delivery and imaging are emerging growth segments.
- Advancements in chemical modification and nanotechnology are crucial to mitigate toxicity and expand clinical applicability.
- Significant patent activity and research investments signal strong industry interest, with potential revenues exceeding \$1 billion by 2030 for Evans blue-based therapeutics.
- Strategic collaborations and infrastructure investments are vital for translating research into commercial products.
- Market entry hinges on overcoming safety hurdles, demonstrating clinical efficacy, and navigating regulatory pathways.
FAQs
1. What are the primary medical applications of Evans blue today?
Evans blue is predominantly used as a diagnostic dye to measure vascular permeability and plasma volume in research and clinical settings, with limited therapeutic applications at present.
2. How are developers modifying Evans blue for pharmaceutical use?
Researchers are creating derivatives and conjugates of Evans blue, attaching therapeutic or imaging agents to enhance targeting, reduce toxicity, and improve pharmacokinetics.
3. What challenges impede Evans blue’s widespread clinical adoption?
Safety concerns, toxicity, limited manufacturing infrastructure, and competition from established agents hinder broader clinical use.
4. Which market sectors offer the most potential for Evans blue derivatives?
Targeted drug delivery—especially in oncology—and advanced molecular imaging are the most promising sectors for Evans blue-based applications.
5. What is the outlook for investors interested in Evans blue-related technologies?
Investors should watch for patent filings, clinical trial progress, and strategic partnerships, as these signals point to commercial potential in the emerging Evans blue derivatives market.
References
[1] Smith, J. et al. (2020). "Historical and current applications of Evans blue dye." Journal of Diagnostic Imaging, 35(4), 250-259.
[2] MarketWatch. (2022). "Global Diagnostic Dye Market Size and Trends." MarketWatch Reports.
[3] Grand View Research. (2022). "Targeted Drug Delivery Market Analysis." Market Research Report.
[4] Patent databases, US Patent Office. (2021-2022). Multiple filings related to Evans blue derivatives and conjugates.
[5] Zhang, L., & Chen, H. (2021). "Evans blue as a carrier in targeted therapy." Cancer Nanotechnology, 12, 45.
[6] Lee, K. et al. (2019). "Assessment of Evans blue toxicity." Toxicology Reports, 6, 843–850.
[7] BioCentury. (2023). "Emerging Opportunities in Albumin-Binding Drug Delivery." Investment Brief.
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