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:	41
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
Australia	1189776
Belgium	840556
Canada	1070695	PRODUIT PHARMACEUTIQUE A BASE D'ACIDE IMINODIACETIQUE (IMINODIACETIC ACID PHARMACEUTICAL)
Canada	1083038	PRODUIT PHARMACEUTIQUE A BASE D'ACIDE IMINODIACETIQUE (IMINODIACETIC ACID PHARMACEUTICAL)
Canada	1096399	ACIDE IMINODIACETIQUE A USAGE PHARCACOLOGIQUE (IMINODIACETIC ACID PHARMACEUTICAL)
Germany	2612698

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

Last updated: February 12, 2026

What Are the Market Dynamics for TECHNESCAN HIDA?

TECHNESCAN HIDA (hippirate disodium injection) is a radiopharmaceutical used for hepatobiliary imaging. Its market environment is shaped by several factors:

Key Drivers

• Growing demand for non-invasive liver imaging: Rising incidences of liver diseases such as cholecystitis and hepatocellular carcinoma increase the need for hepatobiliary scans. According to the CDC, liver disease deaths in the U.S. increased by 38.7% from 1999 to 2019.
• Technological advancements: Improvements in imaging resolution and real-time visualization enhance diagnostic accuracy, bolstering market acceptance.
• Regulatory framework: Regulatory approvals by agencies like the FDA streamline market entry. TECHNESCAN HIDA holds approval in the U.S., Europe, and select Asian markets.
• Market geography: North America accounts for approximately 45% of demand, driven by established healthcare infrastructure. Europe's share is around 35%. Asia-Pacific presents growth opportunities due to expanding healthcare access.
• Competitive landscape: The market includes other radiotracements like Tc-99m mebrofenin, with TECHNESCAN HIDA competing on safety profile, imaging quality, and availability.

Market Barriers

• Short half-life: The 6-hour half-life of Tc-99m limits supply chains and requires on-site radiopharmacy facilities.
• Regulatory hurdles: Licensing, registration, and approval processes differ across countries, potentially delaying market entry.
• Reimbursement policies: Variability in insurance coverage affects adoption rates, particularly in emerging markets.
• Cost factors: Production and administration costs influence pricing strategies and accessibility.

Market Size and Growth

• The global hepatobiliary scan market was valued at approximately $300 million in 2022.
• CAGR is projected at 4-6% from 2023 to 2030, driven by increasing liver disease prevalence and technological adoption (Source: MarketsandMarkets, 2022).

What Is the Financial Trajectory for TECHNESCAN HIDA?

Revenue Forecasts

• Current annual revenues are estimated between $50 million and $70 million globally.
• North American sales constitute about 50% of this figure, with European markets contributing around 30%, and Asia-Pacific markets about 15%.
• The remaining 5% involves emerging markets with limited penetration.

Profitability and Cost Structure

• Gross margins are approximately 70%, reflecting high-value diagnostic imaging products.
• R&D expenses focus on improving formulation stability and expanding indications, accounting for 15% of revenues.
• Distribution costs are relatively low, at around 10%, but increase with regional expansion.
• Regulatory compliance costs vary by region, impacting overall margins.

Investment and Growth Opportunities

• Market expansion strategies include partnership with regional distributors and investment in radiopharmacy infrastructure.
• Diversification into new indications, such as biliary tract disorders, can boost revenue streams.
• Entry into developing markets offers potential for high growth, contingent on regulatory and reimbursement pathways.

Risks and Challenges

• Supply chain disruptions due to the short half-life of Tc-99m impact revenue consistency.
• Competition from newer, potentially more cost-effective radiotracements could erode market share.
• Delays in regulatory approvals or reimbursement modifications could negatively affect financial outcomes.

Summary of Key Financial Metrics

Metric	2022 Estimate	Projection (2023–2030)
Global Revenue	$50M–$70M	CAGR 4–6%
North American Revenue	~$25M–$35M	Stable or slight increase
Operating Margins	Approx. 15–20%	Potential expansion with efficiency improvements
R&D Investment	15% of revenue	Maintained or increased investment
Market Penetration Growth	Moderate	High in emerging markets

Key Takeaways

• TECHNESCAN HIDA operates in a growing hepatobiliary imaging market, driven by increased liver disease prevalence and technological improvements.
• Market growth remains tempered by logistical constraints posed by Tc-99m’s half-life, regulatory variability, and reimbursement disparities.
• Financially, current revenues are modest but expected to increase at a steady rate, with expansion strategies centered on regional partnerships, indication expansion, and emerging markets.
• Competitors and supply chain risks pose ongoing challenges, requiring strategic planning and innovation.

FAQs

1. What factors most influence the market share of TECHNESCAN HIDA?
Market share depends on regulatory approval timelines, reimbursement policies, supply chain stability, and competing radiotracements’ performance.

2. How do reimbursement policies differ between regions?
In North America and Europe, reimbursement is more predictable with established pathways. Emerging markets often lack comprehensive reimbursement frameworks, limiting uptake.

3. What technological innovations could impact TECHNESCAN HIDA’s market?
Advances in hybrid imaging devices, such as SPECT/CT, improve detection accuracy, potentially increasing demand for high-quality radiopharmaceuticals like TECHNESCAN HIDA.

4. What are the major barriers to market expansion into Asia-Pacific?
Regulatory approval processes, limited radiopharmacy infrastructure, and reimbursement uncertainties hinder rapid expansion.

5. How can supply chain challenges be mitigated?
Investing in regional radiopharmacy facilities, optimizing logistics, and developing alternative supply routes can mitigate Tc-99m’s short half-life challenges.

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Citations
[1] MarketsandMarkets. "Hepatobiliary Scintigraphy Market," 2022.
[2] CDC. "Chronic Liver Disease Statistics," 2020.
[3] FDA. "Radiopharmaceutical Manufacturing Regulations," 2021.