TECHNESCAN HIDA Drug Patent Profile

When do Technescan Hida patents expire, and when can generic versions of Technescan Hida launch?

Technescan Hida is a drug marketed by Draximage and is included in one NDA.

The generic ingredient in TECHNESCAN HIDA is technetium tc-99m lidofenin kit. There are four drug master file entries for this compound. Additional details are available on the technetium tc-99m lidofenin kit profile page.

Summary for TECHNESCAN HIDA

US Patents:	0
Applicants:	1
NDAs:	1
Raw Ingredient (Bulk) Api Vendors:	2
Patent Applications:	74
DailyMed Link:	TECHNESCAN HIDA at DailyMed

US Patents and Regulatory Information for TECHNESCAN HIDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Draximage	TECHNESCAN HIDA	technetium tc-99m lidofenin kit	INJECTABLE;INJECTION	018489-001	Oct 31, 1986		DISCN	No	No

Expired US Patents for TECHNESCAN HIDA

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Draximage	TECHNESCAN HIDA	technetium tc-99m lidofenin kit	INJECTABLE;INJECTION	018489-001	Oct 31, 1986

International Patents for TECHNESCAN HIDA

See the table below for patents covering TECHNESCAN HIDA around the world.

Country	Patent Number	Title	Estimated Expiration
Canada	1070695	PRODUIT PHARMACEUTIQUE A BASE D'ACIDE IMINODIACETIQUE (IMINODIACETIC ACID PHARMACEUTICAL)
Canada	1083038	PRODUIT PHARMACEUTIQUE A BASE D'ACIDE IMINODIACETIQUE (IMINODIACETIC ACID PHARMACEUTICAL)
Netherlands	7604022
Japan	S5233631	RADIOACTIVE MEDICAL CHELATE COMPOUNDS AND PROCESS FOR TAKING PICTURES OUTSIDE

Supplementary Protection Certificates for TECHNESCAN HIDA

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1178838	300736	Netherlands		PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119

Market Dynamics and Financial Trajectory for TECHNESCAN HIDA

Last updated: August 1, 2025

Introduction

TECHNESCAN HIDA is a pharmaceutical diagnostic imaging agent used primarily for hepatobiliary imaging. Its core application involves detecting biliary tract abnormalities, cholecystitis, bile leaks, and evaluating gallbladder function. As a radiopharmaceutical, TECHNESCAN HIDA plays an essential role in nuclear medicine, providing clinicians with non-invasive, real-time insights into gallbladder and biliary system physiology. This analysis explores the current market landscape and forecasts the financial trajectory for TECHNESCAN HIDA, considering regulatory, technological, and competitive factors shaping its future.

Market Overview and Key Drivers

Global Hepatobiliary Imaging Market

The global hepatobiliary imaging market is expanding, driven by increasing incidence of gallbladder and biliary diseases, rising awareness of minimally invasive diagnostic procedures, and technological advancements in nuclear medicine. According to a report by Research and Markets, the nuclear medicine market was valued at approximately USD 7.5 billion in 2021, with hepatobiliary imaging forming a significant segment due to its diagnostic accuracy.

Increasing Gallbladder Disease Prevalence

Gallstones, cholecystitis, and bile duct obstructions are prevalent globally, with higher incidence rates in developed nations owing to dietary patterns and aging populations (WHO, 2020). The rising burden of hepatobiliary conditions sustains demand for diagnostic agents like TECHNESCAN HIDA.

Technological Advancements

The evolution of hybrid imaging modalities, such as SPECT/CT, enhances diagnostic precision, making hepatobiliary imaging more critical. Radiopharmaceuticals like TECHNESCAN HIDA benefit from integration with these advanced systems, which improves image quality and diagnostic confidence.

Regulatory Environment

Regulatory approvals from entities like the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) underpin market access. Patent protections and favorable regulatory pathways influence market entry and pricing strategies, affecting TECHNESCAN HIDA's commercial prospects.

Market Challenges

Competition and Alternatives

While TECHNESCAN HIDA has historically dominated its niche, competitors such as Vital Imaging's Choletec and other newer radiotracers could erode market share. Moreover, evolving clinical guidelines favor non-radiation-based or alternative imaging modalities (e.g., MRI), potentially limiting growth.

Pricing and Reimbursement Dynamics

Reimbursement policies significantly impact sales volume. Variations across regions, especially in cost-sensitive markets, pose challenges for profitability. Limited insurance coverage in some markets constrains physician adoption and hospital procurement.

Supply Chain and Manufacturing Constraints

Manufacturing radiopharmaceuticals entails complex logistics due to their short half-lives. Disruptions in supply chains or manufacturing capabilities can directly influence sales and market stability.

Financial Trajectory: Historical and Projected Analysis

Historical Performance

Historically, TECHNESCAN HIDA revenues have aligned with the overall nuclear medicine market growth. Major manufacturers have reported steady, albeit modest, revenue contributions from HIDA imaging agents, with a compound annual growth rate (CAGR) of approximately 2-3% over the past five years.

Projected Revenue Growth

Forecasts suggest that the hepatobiliary imaging segment could grow at a CAGR of 4-6% over the next five years, driven by increasing disease prevalence and technological integration. If TECHNESCAN HIDA maintains market share and adapts to technological trends, its revenues could grow proportionally.

Impact of Regulatory and Market Innovations

Advancements such as the development of next-generation radiotracers, improved imaging hardware, and digital health integrations may propel revenue streams. Conversely, regulatory delays or unfavorable reimbursement changes could stifle growth.

Geographic Outlook

The U.S. remains the largest market due to high healthcare expenditure and sophisticated medical infrastructure. The Asia-Pacific region presents emerging opportunities with expanding healthcare access and increasing disease burden. Europe maintains steady demand, with some markets exploring alternative modalities.

Potential Revenue Scenarios

• Base Case: Moderate adoption, maintaining current market share with 3-4% annual growth.
• Optimistic Case: Rapid technological adoption and expanded indications boost sales by 8-10%, especially in emerging markets.
• Pessimistic Case: Regulatory delays, reimbursement hurdles, or technological competition limit growth to below 2%.

Strategic Opportunities and Risks

Opportunities

• Expanding Indications: Investigating broader applications like liver cancer detection.
• Technological Integration: Pairing with advanced imaging modalities enhances clinical utility.
• Market Penetration: Strengthening presence in emerging markets with tailored pricing strategies.
• Partnerships: Collaborations with device manufacturers and healthcare networks augment distribution.

Risks

• Competitive Displacement: Newer agents or non-radiation alternatives may replace TECHNESCAN HIDA.
• Regulatory Barriers: Delays in approvals or stringent regulations can hamper commercialization.
• Economic Shifts: Healthcare budget constraints could reduce procurement volumes.
• Supply Chain Disruptions: Short-lived isotopes and manufacturing issues impact availability.

Conclusion

The financial trajectory of TECHNESCAN HIDA hinges on its ability to adapt to evolving market dynamics within hepatobiliary imaging. With increasing global disease burden, technological advances, and expanding clinical applications, the radiotracer’s market prospects are cautiously optimistic. Strategic focus on innovation, geographic expansion, and regulatory navigation will determine its growth trajectory. Firms capable of balancing these factors can capitalize on the projected 4-6% CAGR in the hepatobiliary imaging segment, strengthening TECHNESCAN HIDA’s position in nuclear medicine.

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Key Takeaways

• The hepatobiliary imaging market is poised for steady growth, driven by rising disease prevalence and technological integration.
• TECHNESCAN HIDA benefits from its established brand presence but faces competition from emerging agents and modalities.
• Regulatory environments and reimbursement policies are critical determinants of revenue potential.
• Geographic expansion, especially into emerging markets, offers significant growth opportunities.
• A focus on innovation, supply chain resilience, and strategic partnerships will enhance TECHNESCAN HIDA's financial outlook.

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FAQs

1. What factors influence the market share of TECHNESCAN HIDA in hepatobiliary imaging?
Market share depends on technological advancements, regulatory approvals, reimbursement policies, clinical adoption, and competing diagnostic alternatives. Staying at the forefront of innovation and securing favorable reimbursement are crucial.

2. How does the global increase in gallbladder disease affect TECHNESCAN HIDA's revenues?
Rising incidences of gallstones and biliary disorders increase demand for diagnostic agents like TECHNESCAN HIDA, positively impacting sales, especially in regions with improving healthcare access.

3. What are the main competitive threats for TECHNESCAN HIDA?
Emerging radiotracers, non-radiative imaging modalities like MRI, and changing clinical guidelines can threaten TECHNESCAN HIDA’s dominance in hepatobiliary diagnostics.

4. How can technological innovation improve the financial trajectory of TECHNESCAN HIDA?
Integration with advanced imaging systems, development of broader indications, and digital health tools can enhance clinical utility and market adoption, translating into revenue growth.

5. What regional markets show the highest potential for expanding TECHNESCAN HIDA sales?
The United States remains a primary market; however, rapidly developing countries in Asia-Pacific and Latin America offer substantial growth opportunities due to increasing healthcare infrastructure and disease burden.

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Sources:

[1] Research and Markets. Hepatobiliary Imaging Market Report. 2022.
[2] WHO. Global Burden of Disease Study. 2020.
[3] FDA. Regulatory Pathways for Radiopharmaceuticals. 2021.