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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 and one FDA Regulatory Exclusivity.

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
Cardinal Health 414	LYMPHOSEEK KIT	technetium tc-99m tilmanocept	INJECTABLE;INJECTION	202207-001	Mar 13, 2013		RX	Yes	Yes

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
Australia	2010208624	Compositions for radiolabeling diethylenetriaminepentaacetic acid (DTPA)-dextran
European Patent Office	2392012	COMPOSITIONS DE RADIOMARQUAGE D'ACIDE DIÉTHYLÈNETRIAMINEPENTAACÉTIQUE (DTPA)-DEXTRAN (COMPOSITIONS FOR RADIOLABELING DIETHYLENETRIAMINEPENTAACETIC ACID (DTPA)-DEXTRAN)
World Intellectual Property Organization (WIPO)	0069473
Japan	2015164933	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 DIETHYLENETRIAMINEPENTAACETIC ACID (DTPA)-DEXTRAN)
Canada	2750230	COMPOSITIONS DE RADIOMARQUAGE D'ACIDE DIETHYLENETRIAMINEPENTAACETIQUE (DTPA)-DEXTRAN (COMPOSITIONS FOR RADIOLABELING DIETHYLENETRIAMINEPENTAACETIC ACID (DTPA)-DEXTRAN)
Japan	6040276

Supplementary Protection Certificates for LYMPHOSEEK KIT

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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
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

LYMPHOSEEK KIT Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Lymphoseek®

Introduction to Lymphoseek®

Lymphoseek® (technetium Tc 99m tilmanocept) is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures. It is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Approved by the U.S. Food and Drug Administration (FDA) in March 2013, Lymphoseek® is indicated for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma[1][4].

Market Expansion and Global Reach

Navidea Biopharmaceuticals, the original developer of Lymphoseek®, has been actively expanding its global market presence. In 2014, the company entered into a distribution agreement for Lymphoseek® in Taiwan with Global Medical Solutions Taiwan, Ltd. (GMST), marking its first presence in Asia. This move was part of a broader strategy to grow the product's sales globally, building on its success in the United States and other regions like Canada and the Middle East[1].

Distribution and Licensing Agreements

In 2016, Navidea Biopharmaceuticals executed a Letter of Intent (LOI) with Cardinal Health for the sale of all rights, title, and interest to Lymphoseek® for all FDA-approved, pending, and future oncology diagnostic indications in North America. Under this agreement, Navidea received $80 million at closing, with future consideration tied to annual sales and certain sales-based milestones, capping the total consideration at $310 million. This deal allowed Cardinal Health to market, sell, and distribute Lymphoseek® in North America, while Navidea retained rights to non-competitive diagnostic indications and all therapeutic applications[2].

Financial Implications of Licensing Agreements

The licensing agreement with Cardinal Health provided significant financial resources to Navidea Biopharmaceuticals. The initial payment of $80 million and the potential for up to $310 million in total consideration helped the company repay outstanding debt and accelerate the development of its pipeline of diagnostic products, including those focused on Rheumatoid Arthritis and Cardiovascular disease[2].

Impact on Clinical Development and Regulatory Timelines

Despite the COVID-19 pandemic, Navidea Biopharmaceuticals reported minimal impact on its clinical development and regulatory timelines. However, there were delays in enrollment for the NAV3-32 clinical study in the UK and regulatory approval processes in India due to pandemic-related shutdowns. The company continued to advance its Manocept platform, including studies in Kaposi's Sarcoma (KS), Rheumatoid Arthritis (RA), and infectious diseases like leishmaniasis[3].

Market Performance and Adoption

Lymphoseek® has demonstrated strong market performance, particularly in enhancing the efficiency of lymphatic mapping procedures. A case study at Mercy Medical Center showed that using Lymphoseek® reduced the time from injection to lymph node detection from 2-2.5 hours to just 30 minutes, with high signal intensity and accuracy. This efficiency gain allowed for more surgical cases to be performed per day, improved patient satisfaction, and reduced overall hospital visit times[4].

Safety and Efficacy

Lymphoseek® has been praised for its safety profile and efficacy. It poses a risk of hypersensitivity reactions due to its chemical similarity to dextran, but clinical trials and real-world use have shown it to be highly accurate and efficient in detecting lymph nodes. The rapid injection site clearance and strong signal intensity have made it a preferred choice for surgeons and patients alike[4].

Market Size and Potential

The market for Lymphoseek® is substantial, given the high incidence of cancer globally. Cancer is the second leading cause of death in the United States and Europe, with millions of new cases diagnosed annually. The FDA approval and European approval for imaging and intraoperative detection of sentinel lymph nodes in various solid tumor cancers position Lymphoseek® to address a significant market need. The potential for expanding lymph node mapping to other solid tumor cancers such as prostate, gastric, colon, gynecologic, and non-small cell lung cancers further enhances its market potential[3].

Competitive Landscape

The diagnostic radiopharmaceutical market is competitive, with several players offering various products for lymphatic mapping and cancer diagnostics. However, Lymphoseek®'s unique receptor-targeted mechanism and its approval for specific indications give it a competitive edge. The partnership with Cardinal Health, a major player in the nuclear pharmacy services sector, has also strengthened its market position in North America[2].

Future Development and Expansion

Navidea Biopharmaceuticals continues to evaluate emerging data to define areas of focus and development pathways for the Manocept platform. Ongoing studies in KS, RA, and infectious diseases, along with the potential for therapeutic applications, suggest a robust future for Lymphoseek® and its derivatives. The company's efforts to capitalize on the Manocept platform through partnering options and further clinical trials are expected to drive growth and expand the product's reach[3].

Key Takeaways

• Global Expansion: Lymphoseek® has been introduced in various global markets, including Asia, through strategic distribution agreements.
• Financial Gains: The licensing agreement with Cardinal Health provided significant financial resources to Navidea Biopharmaceuticals.
• Clinical Efficiency: Lymphoseek® has improved the efficiency of lymphatic mapping procedures, reducing detection times and enhancing patient satisfaction.
• Market Potential: The product addresses a substantial market need in cancer diagnostics, with potential for expansion into other solid tumor cancers.
• Competitive Edge: Lymphoseek®'s unique mechanism and approvals give it a competitive edge in the diagnostic radiopharmaceutical market.

FAQs

What is Lymphoseek® used for?

Lymphoseek® is used in lymphatic mapping procedures to help in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma. It identifies the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer[1][4].

Who distributes Lymphoseek® in North America?

Cardinal Health distributes Lymphoseek® in North America following a licensing agreement with Navidea Biopharmaceuticals in 2016[2].

How has the COVID-19 pandemic affected Lymphoseek®'s development?

The COVID-19 pandemic caused minor delays in clinical trial enrollments and regulatory approvals but did not significantly impact the overall development and regulatory timelines of Lymphoseek®[3].

What are the safety concerns associated with Lymphoseek®?

Lymphoseek® may pose a risk of hypersensitivity reactions due to its chemical similarity to dextran. However, it has been shown to be safe and effective in clinical use[4].

What is the market potential for Lymphoseek®?

The market potential for Lymphoseek® is substantial, given the high incidence of cancer globally and its approval for specific indications. It also has potential for expansion into other solid tumor cancers[3].

Sources

1. Navidea Biopharmaceuticals Expands Lymphoseek® Global Commercialization Efforts - Navidea Biopharmaceuticals, Inc.
2. Cardinal Health Pays $310 Million for Struggling Navidea's Lymphoseek - Biospace
3. Navidea Biopharmaceuticals, Inc. - SEC Filings - Navidea Biopharmaceuticals, Inc.
4. Lymphoseek Delivering Efficiency Case Study - Mercy Medical Center - Cardinal Health