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 September 27, 2033. 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 Generic Entry Opportunity 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 two US patents and one FDA Regulatory Exclusivity.

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

Patents protecting LYMPHOSEEK KIT

FDA Regulatory Exclusivity protecting LYMPHOSEEK KIT

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	Y
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

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	2017066148	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 (COMPOSITION FOR RADIOLABELING DIETHYLENETRIAMINEPENTAACETIC ACID (DTPA)-DEXTRAN)
Canada	2750230	COMPOSITIONS DE RADIOMARQUAGE D'ACIDE DIETHYLENETRIAMINEPENTAACETIQUE (DTPA)-DEXTRAN (COMPOSITIONS FOR RADIOLABELING DIETHYLENETRIAMINEPENTAACETIC ACID (DTPA)-DEXTRAN)
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)
European Patent Office	2392012	COMPOSITIONS DE RADIOMARQUAGE D'ACIDE DIÉTHYLÈNETRIAMINEPENTAACÉTIQUE (DTPA)-DEXTRAN (COMPOSITIONS FOR RADIOLABELING DIETHYLENETRIAMINEPENTAACETIC ACID (DTPA)-DEXTRAN)

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