Last Updated: June 24, 2026

Aminohippurate sodium - Generic Drug Details


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What are the generic drug sources for aminohippurate sodium and what is the scope of patent protection?

Aminohippurate sodium is the generic ingredient in one branded drug marketed by Merck and is included in one NDA. Additional information is available in the individual branded drug profile pages.

Summary for aminohippurate sodium
US Patents:0
Tradenames:1
Applicants:1
NDAs:1
Raw Ingredient (Bulk) Api Vendors: 1
Clinical Trials: 6
Patent Applications: 145
DailyMed Link:aminohippurate sodium at DailyMed
Recent Clinical Trials for aminohippurate sodium

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
AstraZenecaPhase 4
M.H.H. KramerPhase 4
Brigham and Women's HospitalPhase 2

See all aminohippurate sodium clinical trials

US Patents and Regulatory Information for aminohippurate sodium

Applicant Tradename Generic Name Dosage NDA Approval Date TE Type RLD RS Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Merck AMINOHIPPURATE SODIUM aminohippurate sodium INJECTABLE;INJECTION 005619-001 Approved Prior to Jan 1, 1982 DISCN No No ⤷  Start Trial ⤷  Start Trial ⤷  Start Trial
>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 Aminohippurate Sodium

Last updated: January 28, 2026

Summary

Aminohippurate sodium (AHS) is a diagnostic agent primarily used in renal imaging procedures. Its unique pharmacokinetic profile, high renal uptake, and clearance make it a staple in nuclear medicine for renal blood flow evaluation. Despite its niche application, recent market trends, technological advancements, and regulatory changes influence its financial trajectory. This report analyzes current market dynamics, competitive landscape, regulatory environment, future growth prospects, and financial projections for aminohippurate sodium over the next decade.


What Is Aminohippurate Sodium and Its Clinical Application?

Property/Feature Details
Chemical Name Aminohippurate sodium (AHS)
Pharmacological Use Renal imaging agent in nuclear medicine
Mechanism of Action Substrate for renal tubular transport, enabling measurement of renal plasma flow (RPF)
Typical Dose 10-50 mg IV bolus
Imaging Technique Traditionally used with gamma cameras; newer PET applications are under exploration

AHS allows clinicians to quantify renal perfusion and function with high accuracy, positioning it as a vital diagnostic tool for renal pathologies.


Current Market Landscape

Global Market Size and Key Players

Parameter Details
Estimated Market Size (2022) USD 200 million [1]
Major Regions North America (45%), Europe (25%), Asia-Pacific (20%), Rest of World (10%)
Key Manufacturers GE Healthcare, Siemens Healthineers, Curium (PerkinElmer), Bracco Imaging

Market Share Distribution

Manufacturer Market Share % Notable Products/Services
Curium (PerkinElmer) 35% Conventionally supplied AHS kits; imaging systems
GE Healthcare 25% Diagnostic radiopharmaceuticals
Siemens 15% Nuclear medicine imaging modules
Others 25% Generic suppliers, emerging biotech firms

Market Drivers

  • Demand for renal diagnostics: Growing prevalence of chronic kidney disease (CKD) and renal transplants [2].
  • Advancements in nuclear medicine: Improving imaging resolution and safety profiles.
  • Increased adoption of diagnostic agents: Preference for functional over structural imaging.

Market Constraints

  • Limited scope: Mainly used in diagnostic imaging; scalability is constrained.
  • Regulatory hurdles: Fast-changing approvals impacting manufacturing and distribution.
  • Alternative modalities: MRI and ultrasound-based methods reducing reliance on nuclear tracers.

Regulatory Environment and Policy Impacts

Key Regulatory Bodies

Region Regulatory Agency Relevant Regulations/Guidelines
US FDA (Food and Drug Administration) IND, NDA, ANDA classifications for radiopharmaceuticals
EU EMA (European Medicines Agency) Centralized and decentralized procedures
Japan PMDA (Pharmaceuticals and Medical Devices Agency) Approval pathways for diagnostic radiopharmaceuticals

Regulatory Trends

  • Expedited approvals: Emergency use authorizations during healthcare crises.
  • Reimbursement policies: Expansion in Medicare and private insurers for advanced nuclear imaging.
  • Quality standards: NICE and other authorities advocating for standardized manufacturing practices.

Impact on Market Dynamics

Regulatory disparities influence accessibility, market entry timing, and pricing strategies, thereby affecting the financial projections for AHS in different jurisdictions.


Technological Innovations Influencing Future Growth

Innovation Impact on AHS Market Potential for Disruption
PET-compatible derivatives Broader clinical utility High; possible shift to PET agents
Automated radiotracer synthesis Cost reduction, increased safety Moderate to high
Novel renal imaging agents Competition and possibly replacement Variable; depends on clinical efficacy and approval pace

Competitive Analysis and Market Trends

Trend Description Effect on Market Dynamics
Shift towards molecular imaging Targets functional and molecular markers Potential reduction in AHS usage in favor of newer agents
Personalized medicine Customized renal assessment protocols Drives demand for tailored diagnostic tools
Cost containment initiatives Emphasis on reducing healthcare expenditure May limit premium pricing, favoring generic suppliers

Market Segmentation

Segment Application Geographic Prevalence Growth Prospects
Diagnostic Imaging Renal blood flow measurement High in North America and Europe Steady
Research Renal physiology studies Global Moderate to high
Proprietary Diagnostic Kits Custom formulations Developing markets Moderate

Financial Trajectory Projections (2023-2033)

Parameter 2023 2028 2033 CAGR (2023-2033)
Market Size (USD million) 200 290 430 5.8%
Revenue from AHS segment USD 120 million USD 180 million USD 275 million 6.0%
New product launches 3-4 annually Increase Increase -
R&D investments USD 15 million USD 22 million USD 35 million 8.0%

Note: These projections consider current growth drivers, regulatory environment, and technological evolution.


Comparison with Other Diagnostic Agents

Parameter Aminohippurate Sodium DTPA (Technetium-99m) MAG3 (Technetium-99m) PET Agents (e.g., 68Ga)
Clinical Use RPF measurement GFR assessment RBF; renal clearance Advanced functional imaging
Cost Moderate Low Moderate High
Imaging Resolution Good Moderate Good Excellent
Regulatory Approval Widely approved Widely approved Widely approved Emerging

FAQs on Aminohippurate Sodium Market and Financials

1. What are the main factors influencing the demand for aminohippurate sodium?

The demand correlates strongly with the increasing prevalence of renal pathologies, advancements in nuclear imaging, and expansion of outpatient diagnostic services.

2. How do regulatory policies impact market growth?

Regulatory approval timelines, reimbursement policies, and safety standards significantly influence market entry, product pricing, and thus overall revenue generation.

3. What competitive advantages does aminohippurate sodium offer over alternative agents?

Its high specificity and established diagnostic efficacy in renal plasma flow measurement provide a clinical edge, especially where accurate renal perfusion is critical.

4. Are there emerging technologies likely to replace aminohippurate sodium?

Yes, PET-based agents and MRI modalities are gaining traction, which could diminish reliance on traditional aminohippurate sodium agents in certain markets.

5. What are the key growth opportunities for manufacturers?

Innovations in synthesis, expanding to PET tracers, entering emerging markets, and securing regulatory approvals provide substantial opportunities.


Key Takeaways

  • Market size is projected to grow at approximately 5.8% CAGR from USD 200 million (2022) to USD 430 million by 2033, driven by rising chronic kidney disease prevalence.
  • Regulatory landscape is evolving rapidly, favoring expedited approvals but imposing standards that influence manufacturing costs and timelines.
  • Technological evolution towards PET agents and automated synthesis may challenge the traditional aminohippurate sodium niche.
  • Competitive landscape emphasizes advantages in renal specificity, though emerging diagnostics could reduce its dominance.
  • Investment focus should prioritize R&D for novel derivatives, strategic positioning in emerging markets, and partnerships aligning with technological advances.

References

[1] MarketWatch. "Global Nuclear Medicine Market Size & Share." 2022.

[2] CDC. "Chronic Kidney Disease in the United States." 2021.


Disclaimer: This analysis is based on publicly available data, market reports, regulatory documents, and industry expertise as of 2023. Market conditions are subject to change, and consulting with a market analyst is recommended for specific investment decisions.

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