Technetium tc-99m tilmanocept - Generic Drug Details

What are the generic sources for technetium tc-99m tilmanocept and what is the scope of patent protection?

Technetium tc-99m tilmanocept is the generic ingredient in one branded drug marketed by Cardinal Health 414 and is included in one NDA. There are two patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Technetium tc-99m tilmanocept has thirty patent family members in twelve countries.

One supplier is listed for this compound.

Summary for technetium tc-99m tilmanocept

International Patents:	30
US Patents:	2
Tradenames:	1
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Clinical Trials:	7
DailyMed Link:	technetium tc-99m tilmanocept at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for technetium tc-99m tilmanocept

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 technetium tc-99m tilmanocept

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

Sponsor	Phase
John O. Prior	Early Phase 1
National Cancer Institute (NCI)	Phase 2
Eben Rosenthal	Phase 2

See all technetium tc-99m tilmanocept clinical trials

US Patents and Regulatory Information for technetium tc-99m tilmanocept

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

International Patents for technetium tc-99m tilmanocept

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)

Supplementary Protection Certificates for technetium tc-99m tilmanocept

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

Technetium tc-99m tilmanocept Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Technetium Tc-99m Tilmanocept

Introduction

Technetium Tc-99m tilmanocept, marketed under the trade name Lymphoseek, is a radiopharmaceutical diagnostic imaging agent that has revolutionized the field of oncologic surgery. Here, we delve into the market dynamics and financial trajectory of this innovative drug.

Market Approval and Adoption

Technetium Tc-99m tilmanocept was approved by the U.S. Food and Drug Administration (FDA) for the imaging of lymph nodes and guiding sentinel lymph node biopsy in various cancers, including breast cancer, melanoma, and certain types of head and neck cancer[1][4][5].

Clinical Applications and Market Demand

The drug's primary use in lymphatic mapping and sentinel lymph node biopsy has created a significant demand in the oncologic surgery market. Its ability to accurately identify and analyze sentinel lymph nodes has improved the staging and treatment planning for cancer patients, making it a cornerstone in surgical oncology[4].

Competitive Landscape

In the radiopharmaceutical diagnostic market, technetium Tc-99m tilmanocept stands out due to its unique mechanism of action and high specificity for sentinel lymph nodes. Its receptor-targeted approach, binding to CD206 receptors on macrophages, offers superior accuracy and retention in lymph nodes compared to conventional radiocolloids[1][4].

Development and Expansion

Navidea Biopharmaceuticals, the developer of technetium Tc-99m tilmanocept, is exploring its potential in other clinical applications. The company has conducted Phase 2 and Phase 3 trials to evaluate the drug's use in diagnosing and monitoring rheumatoid arthritis (RA) and other conditions. Although some trials were terminated due to sponsor decisions, the ongoing research indicates a broader market potential[2][3].

Financial Performance and Projections

Navidea Biopharmaceuticals, as the primary developer and marketer of technetium Tc-99m tilmanocept, has seen varying financial trends. The company has a history of operating losses but is working towards profitability through the successful commercialization of its products. The financial condition is influenced by factors such as research and development costs, regulatory approvals, and market competition[2].

Revenue Streams and Royalties

The revenue for technetium Tc-99m tilmanocept is generated through its commercial sales and potential royalties from licensing agreements. Navidea Biopharmaceuticals relies on these revenue streams to support its ongoing research and development activities. The company's financial reports indicate that while there are challenges, the market demand for Lymphoseek continues to support its financial trajectory[2].

Regulatory and Orphan Drug Status

Technetium Tc-99m tilmanocept has been granted orphan drug status for head and neck cancer, which provides incentives for further development and marketing. This status can influence the financial trajectory positively by offering tax credits, reduced regulatory fees, and market exclusivity[3].

Challenges and Risks

Despite its market potential, the financial trajectory of technetium Tc-99m tilmanocept is not without challenges. Navidea Biopharmaceuticals faces risks related to regulatory approvals, competition from new technologies, and the impact of global health crises like the COVID-19 pandemic. These factors can affect the company's ability to maintain profitability and grow its market share[2].

Future Outlook

The future outlook for technetium Tc-99m tilmanocept is promising, with ongoing research and potential expansions into new clinical applications. As more long-term data become available, its role in the management of various cancers and other diseases is likely to expand, further solidifying its position in the market and contributing to the company's financial growth[4].

Key Takeaways

• Market Approval: FDA-approved for lymphatic mapping and sentinel lymph node biopsy.
• Clinical Demand: High demand in oncologic surgery for accurate staging and treatment planning.
• Competitive Advantage: Unique receptor-targeted mechanism offering superior accuracy.
• Financial Performance: Navidea Biopharmaceuticals faces operating losses but aims for profitability through commercialization.
• Revenue Streams: Generated through commercial sales and potential royalties.
• Regulatory Incentives: Orphan drug status for head and neck cancer provides market exclusivity and other benefits.
• Future Outlook: Promising with potential expansions into new clinical applications.

Frequently Asked Questions (FAQs)

Q: What is technetium Tc-99m tilmanocept used for? A: Technetium Tc-99m tilmanocept is used for lymphatic mapping and guiding sentinel lymph node biopsy in various cancers, including breast cancer, melanoma, and head and neck cancer.

Q: Who developed technetium Tc-99m tilmanocept? A: The drug was developed by Navidea Biopharmaceuticals, with contributions from several other institutions including the University of California, San Diego.

Q: What is the mechanism of action of technetium Tc-99m tilmanocept? A: It binds to CD206 receptors on macrophages in lymph nodes, allowing for precise localization of sentinel lymph nodes.

Q: Has technetium Tc-99m tilmanocept been granted any special regulatory status? A: Yes, it has been granted orphan drug status for head and neck cancer.

Q: What are the potential future applications of technetium Tc-99m tilmanocept? A: It is being explored for use in diagnosing and monitoring rheumatoid arthritis and other conditions, with potential therapeutic applications in the future.

Cited Sources:

1. DrugBank: Technetium Tc-99m tilmanocept - DrugBank.
2. Navidea Biopharmaceuticals: Navidea Biopharmaceuticals Announces End-of-Phase 2 Type B Meeting with FDA.
3. AdisInsight: Tc 99m tilmanocept - Navidea Biopharmaceuticals.
4. Open MedScience: Technetium-99m Tilmanocept (Lymphoseek) - Open MedScience.
5. FDA: Lymphoseek (technetium Tc 99m tilmanocept) injection.