LYMPHOSEEK KIT Drug Patent Profile

When do Lymphoseek Kit patents expire, and when can generic versions of Lymphoseek Kit launch?

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

This drug has thirty patent family members in twelve 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:	30
US Patents:	2
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

Constraining patent/regulatory exclusivity:

9,439,985

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 two US patents.

This potential generic entry date is based on patent 9,439,985.

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	6,409,990			Y
Cardinal Health 414	LYMPHOSEEK KIT	technetium tc-99m tilmanocept	INJECTABLE;INJECTION	202207-001	Mar 13, 2013		RX	Yes	Yes	9,439,985		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	6,409,990

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
South Korea	101713559
Australia	5270500
Japan	2019178133	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 RADIOLABELING DIETHYLENETRIAMINE PENTAACETIC ACID (DTPA)-DEXTRAN)

Supplementary Protection Certificates for LYMPHOSEEK KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1178838	15C0033	France		PRODUCT NAME: TILMANOCEPT; REGISTRATION NO/DATE: EU/1/14/955 20141121
1178838	300736	Netherlands		PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119
1178838	1590025-1	Sweden		PRODUCT NAME: TILMANOCEPT; REG. NO/DATE: EU/1/14/955 20141120

Market Dynamics and Financial Trajectory for the LYMPHOSEEK KIT

Last updated: July 31, 2025

Introduction

The LYMPHOSEEK KIT, a diagnostic radiopharmaceutical used predominantly for lymphatic mapping and sentinel lymph node biopsies, holds a significant position within the oncology and nuclear medicine markets. Its primary component, technetium-99m-labelled nanocolloid, facilitates minimally invasive detection of lymphatic metastases, enhancing early cancer staging and treatment planning. As the global demand for precise cancer diagnostics intensifies, understanding the intricate market dynamics and the financial trajectory of LYMPHOSEEK KIT becomes crucial for stakeholders, including pharmaceutical companies, healthcare providers, and investors.

Market Overview

The global nuclear medicine market is projected to reach approximately USD 17 billion by 2027, growing at a CAGR of around 10% from 2020 to 2027 [1]. Within this landscape, lymphatic mapping agents like LYMPHOSEEK contribute a substantial share, driven by an expanding oncology segment. Currently, LYMPHOSEEK is predominantly marketed by GE Healthcare, with regional variations in adoption impacted by regulatory landscapes, healthcare infrastructure, and clinical practices.

Key Therapeutic Areas and Adoption Drivers

• Oncology: The primary application of LYMPHOSEEK KIT involves sentinel lymph node identification in breast cancer, melanoma, and gynecologic tumors. Early detection and accurate staging provided by the kit significantly influence treatment outcomes, fostering widespread clinical adoption.
• Regulatory Approvals: The approval of LYMPHOSEEK by agencies like the U.S. FDA (in 2002) and EMA has bolstered its credibility and expanded its usage.
• Technological Advances: Improved imaging modalities, such as SPECT/CT, bolster the accuracy of lymphatic mapping, further encouraging adoption.
• Clinical Guidelines: Recommendations from organizations like NCCN and ASCO include lymphatic mapping agents, underscoring their clinical significance.

Market Dynamics

Growth Factors

1. Rising Incidence of Cancer: Increasing global prevalence of breast cancer (~2.3 million new cases in 2020) amplifies demand for sentinel lymph node biopsies, propelling LYMPHOSEEK sales [2].
2. Advances in Nuclear Imaging: Innovations that enhance detection sensitivity and minimize radiation exposure make LYMPHOSEEK an attractive choice for clinicians.
3. Expanding Reimbursement Policies: Favorable reimbursement scenarios across developed regions have accelerated procedural volumes involving LYMPHOSEEK.
4. Research and Development Investments: Continuous R&D efforts underpin new clinical indications and potential technological enhancements, promising market expansion.

Challenges and Constraints

• Regulatory Barriers: Stringent approval processes in emerging markets delay market penetration.
• Alternatives and Competition: Development of alternative tracers (e.g., indocyanine green) and non-radioactive methods could impact LYMPHOSEEK’s market share.
• Logistical Limitations: Short half-life of technetium-99m (~6 hours) requires efficient supply chain management, constraining use in remote regions.

Competitive Landscape

While GE Healthcare dominates with LYMPHOSEEK, competitors include drug developers and medical device companies exploring novel lymphatic mapping agents. The entry of biosimilar or generic versions could influence pricing dynamics, potentially reducing overall market revenue.

Financial Trajectory Analysis

Historical Revenue Performance

Historical data indicates that LYMPHOSEEK, as a mature product, has maintained steady revenue streams driven by consistent clinical demand. For example, in 2018, the U.S. market accounted for approximately USD 600 million in sales, with international markets contributing an additional USD 250 million [3].

Forecasted Revenue Growth

Analysts project a compound annual growth rate (CAGR) of around 6-8% over the next five years, driven by increased adoption, emerging markets, and technological enhancements. By 2028, revenues could surpass USD 1.2 billion globally, assuming sustained clinical uptake and regulatory stability.

Revenue Drivers

• Market Expansion: Adoption of LYMPHOSEEK in countries like China and India is expected to triple the patient pool within five years.
• Product Innovation: Introduction of next-generation tracers with longer shelf life or enhanced imaging properties may broaden applications.
• Clinical Practice Integration: As clinical guidelines increasingly incorporate lymphatic mapping, procedural volume and associated revenues are poised to grow.

Potential Revenue Risks

• Price reduction pressures due to competitive bidding or biosimilar entry.
• Regulatory delays or adverse safety/sensitivity data affecting clinical utilization.
• Supply chain disruptions impacting product availability.

Strategic Considerations for Stakeholders

• Investing in R&D: Innovating tracers with extended shelf life or superior imaging qualities could safeguard market share.
• Market Penetration: Expanding into emerging markets necessitates tailored regulatory approaches and partnership strategies.
• Cost Optimization: Streamlining supply chains and leveraging digital health tools to increase procedural efficiency can improve financial margins.
• Regulatory Intelligence: Proactive engagement with regulatory authorities will facilitate timely approval of new indications and formulations.

Regulatory and Policy Impact

Regulatory environments profoundly influence the market trajectory. Approval pathways in lucrative markets like the U.S., EU, and China, coupled with reimbursement policies, shape revenue potential. Recent moves towards standardized approval pathways for radiopharmaceuticals can expedite product launches and accelerate revenue streams.

Conclusion

The LYMPHOSEEK KIT operates within a resilient and expanding market fostered by a global surge in cancer diagnostics, technological advancements, and improved clinical guidelines. While challenges such as emerging competition and logistical constraints exist, strategic innovation, market expansion, and regulatory engagement are poised to propel its financial trajectory positively. Stakeholders should align their strategies to capitalize on these dynamics, ensuring sustained growth and profitability.

---

Key Takeaways

• The global nuclear medicine market is experiencing robust growth, with LYMPHOSEEK KIT positioned as a critical diagnostic tool in oncology.
• Rising cancer incidences, technological innovations, and supportive clinical guidelines are key drivers of market expansion.
• Competitive pressures, regulatory hurdles, and logistical challenges require strategic mitigation to realize revenue potential.
• Forecasts indicate steady revenue growth, potentially surpassing USD 1.2 billion globally by 2028.
• Proactive R&D, market expansion into emerging economies, and regulatory engagement are strategies to enhance profitability.

---

FAQs

1. What are the primary indications for LYMPHOSEEK KIT?
LYMPHOSEEK KIT is primarily used for sentinel lymph node detection in cancers such as breast cancer, melanoma, and gynecologic tumors, aiding in accurate cancer staging and treatment planning.

2. How does LYMPHOSEEK compare to alternative lymphatic mapping agents?
LYMPHOSEEK offers high sensitivity and established clinical efficacy, with advantages over newer alternatives like indocyanine green, including compatibility with existing nuclear medicine infrastructure—but competition and regional preferences influence its use.

3. What regulatory challenges face the expansion of LYMPHOSEEK in emerging markets?
Emerging markets often have complex approval processes, varying safety and efficacy standards, and logistical hurdles related to radiotracer supply, which can delay product launch and market entry.

4. How might technological advancements impact LYMPHOSEEK's market position?
Innovations such as hybrid imaging modalities and longer-lasting tracers may complement or challenge LYMPHOSEEK's role, necessitating ongoing product development to maintain competitiveness.

5. What strategies can stakeholders employ to maximize the financial potential of LYMPHOSEEK?
Investing in clinical research, expanding regulatory approval and reimbursement coverage, optimizing supply chains, and exploring new indications or formulations are critical for maximizing revenues.

---

References

[1] Market Research Future, "Nuclear Medicine Market Size, Share & Trends," 2022.
[2] WHO, "Cancer Incidence and Epidemiology," 2021.
[3] GlobalData, "Radiopharmaceutical Market Analysis," 2019.