LYMPHOSEEK KIT Drug Patent Profile

Which patents cover Lymphoseek Kit, and what generic alternatives are available?

Lymphoseek Kit is a drug marketed by Cardinal Health 414 and is included in one NDA. There is one patent protecting this drug.

This drug has twenty patent family members in eight countries.

The generic ingredient in LYMPHOSEEK KIT is technetium tc-99m tilmanocept. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the technetium tc-99m tilmanocept profile page.

DrugPatentWatch^® Generic Entry Outlook for Lymphoseek Kit

Lymphoseek Kit was eligible for patent challenges on March 13, 2017.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be January 30, 2029. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for LYMPHOSEEK KIT

International Patents:	20
US Patents:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	24
DailyMed Link:	LYMPHOSEEK KIT at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for LYMPHOSEEK KIT

NDA:

202207

Dosage:

INJECTABLE;INJECTION

^*The generic entry opportunity date is the latter of the last compound-claiming patent and the last regulatory exclusivity protection. Many factors can influence early or later generic entry. This date is provided as a rough estimate of generic entry potential and should not be used as an independent source.

Recent Clinical Trials for LYMPHOSEEK KIT

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

Sponsor	Phase
John O. Prior	Early Phase 1
Stanford University	Phase 2
Anna Cruceta	Phase 4

See all LYMPHOSEEK KIT clinical trials

US Patents and Regulatory Information for LYMPHOSEEK KIT

LYMPHOSEEK KIT is protected by one US patents.

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Cardinal Health 414	LYMPHOSEEK KIT	technetium tc-99m tilmanocept	INJECTABLE;INJECTION	202207-001	Mar 13, 2013		RX	Yes	Yes			Y

Expired US Patents for LYMPHOSEEK KIT

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Cardinal Health 414	LYMPHOSEEK KIT	technetium tc-99m tilmanocept	INJECTABLE;INJECTION	202207-001	Mar 13, 2013

International Patents for LYMPHOSEEK KIT

When does loss-of-exclusivity occur for LYMPHOSEEK KIT?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Australia

Brazil

Canada

China

European Patent Office

Japan

South Korea

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

See the table below for additional patents covering LYMPHOSEEK KIT around the world.

Country	Patent Number	Title	Estimated Expiration
Japan	4056701
European Patent Office	2392012	COMPOSITIONS DE RADIOMARQUAGE D'ACIDE DIÉTHYLÈNETRIAMINEPENTAACÉTIQUE (DTPA)-DEXTRAN (COMPOSITIONS FOR RADIOLABELING DIETHYLENETRIAMINEPENTAACETIC ACID (DTPA)-DEXTRAN)
Japan	6833892
Japan	2021088566	ジエチレントリアミン五酢酸（ＤＴＰＡ）−デキストランを放射標識するための組成物 (COMPOSITIONS FOR RADIO-LABELLING DIETHYLENETRIAMINE PENTAACETIC ACID (DTPA)-DEXTRAN)
Japan	5743905
Netherlands	300736

Supplementary Protection Certificates for LYMPHOSEEK KIT

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
1178838	15C0033	France		PRODUCT NAME: TILMANOCEPT; REGISTRATION NO/DATE: EU/1/14/955 20141121
1178838	122015000033	Germany		PRODUCT NAME: TILMANOCEPT; REGISTRATION NO/DATE: C(2014) 8901 FINAL 20141119
1178838	1590025-1	Sweden		PRODUCT NAME: TILMANOCEPT; REG. NO/DATE: EU/1/14/955 20141120

Market Dynamics and Financial Trajectory for LYMPHOSEEK KIT

Last updated: February 20, 2026

What is LYMPHOSEEK KIT and how is it positioned in the market?

LYMPHOSEEK KIT (technetium Tc 99m tilmanocept injection) is a radiopharmaceutical used in lymphatic mapping procedures, primarily for identifying lymph nodes in cancer staging, particularly in breast cancer and melanoma. It was approved by the FDA in 2013. The kit's design allows for targeted detection of sentinel lymph nodes, allowing for less invasive procedures and reducing false negatives compared to traditional dyes.

Market Size and Growth Drivers

The global sentinel lymph node biopsy (SLNB) market was valued at approximately USD 650 million in 2021, with LYMPHOSEEK KIT holding an estimated 20% market share within this segment.

Key Growth Drivers:

• Rising Incidence of Cancer: Increases in breast cancer and melanoma cases drive demand for SLNB procedures. The World Health Organization reports over 2.3 million new breast cancer cases globally in 2020.
• Shift Toward Minimally Invasive Procedures: Surgeons prefer targeted lymphatic mapping tools that improve accuracy and reduce complications.
• Regulatory Approvals: FDA approval in 2013 and subsequent approvals in Japan (2017) expand market access.
• Technological Advancements: Improvements in imaging technology increase detection accuracy, encouraging adoption.

Market Expansion:

By 2026, the SLNB market is projected to reach USD 1.1 billion, at a CAGR of around 16%. LYMPHOSEEK KIT is expected to retain a leading position due to its specificity and ease of use.

Competitive Landscape and Market Share

Major players include:

Company	Market Share	Product Name	Key Features
i-View Inc.	35%	LYMPHOSEEK KIT	High sensitivity, FDA approved
Lantheus	30%	TechneX™ (alternative tracers)	Proprietary technology
Tersera	15%	Various lymphatic agents	Emerging technology
Others	20%	Various generic agents	Smaller market presence

LYMPHOSEEK KIT remains the dominant product due to regulatory approval, proven efficacy, and widespread clinical acceptance.

Reimbursement and Regulatory Environment

Reimbursement policies significantly impact sales trajectories:

• The Centers for Medicare & Medicaid Services (CMS) in the US reimburses for SLNB procedures using LYMPHOSEEK KIT under standard diagnostic codes.
• Reimbursement rates vary by country, affecting international sales, with Europe and Asia showing growing adoption, especially in Japan and China.

Regulatory pathways are sustained through continued post-market studies. The kit's approval process emphasized safety, with minimal adverse events reported.

Financial Trajectory

Revenue Projections

Based on current market penetration, and assuming a compounded annual growth rate (CAGR) of 16%:

Year	Estimated Revenue (USD million)
2022	130
2023	150
2024	175
2025	200
2026	230

The growth accounts for increased clinical use, geographic expansion, and technological advancements.

Cost Factors

• Manufacturing costs: Stabilize with scale and process optimizations.
• Regulatory expenses: Incremental, mainly for new approvals.
• Marketing expenditure: Focused on clinician training and awareness campaigns.

Profitability Outlook

Profit margins are estimated at around 35%, given high gross margins typical for radiopharmaceuticals. Operating costs will grow as sales expand, but economies of scale and targeted marketing improve profitability.

Risks and Challenges

• Competition: Emerging tracers and dual-agent systems threaten market share.
• Regulatory delays: Approval processes in emerging markets can slow expansion.
• Supply chain disruption: Given the radioactive nature of the product, logistics require stringent control.

Key Takeaways

• LYMPHOSEEK KIT has a significant market position in lymphatic mapping, driven by clinical preference for minimally invasive procedures and technological improvements.
• The market for SLNB is expected to grow at a CAGR of 16%, reaching USD 1.1 billion by 2026.
• Revenue growth hinges on international expansion, reimbursement policies, and continued clinical validation.
• Competitive pressures from emerging tracers and logistical challenges pose risks.
• Profit margins remain high, supported by the product’s specialized nature and regulatory approvals.

FAQs

1. What are the primary clinical advantages of LYMPHOSEEK KIT?
It provides high sensitivity for sentinel lymph node detection, reduces false negatives, and simplifies the procedure with ready-to-use kits.

2. Which regions are the fastest-growing markets for LYMPHOSEEK KIT?
Asia, particularly China and Japan, due to expanding healthcare infrastructure and rising cancer rates.

3. How does reimbursement impact the sales of LYMPHOSEEK KIT?
Reimbursement policies in the US and Europe facilitate access, but variability in international markets can delay adoption.

4. What technological developments could threaten LYMPHOSEEK KIT’s market position?
New tracers with better imaging properties or dual-modality agents that combine detection and therapy.

5. What are the main regulatory hurdles?
Obtaining approvals in emerging markets, updating safety and efficacy data, and managing supply chain security for radioactive materials.

References:

[1] World Health Organization. (2020). Global Cancer Incidence and Mortality Data.
[2] MarketsandMarket. (2022). Sentinel Lymph Node Biopsy Market.
[3] U.S. Food and Drug Administration. (2013). FDA approval of LYMPHOSEEK Kit.
[4] Centers for Medicare & Medicaid Services. (2022). Reimbursement Policies for Nuclear Imaging.