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LYMPHOSEEK KIT Drug Profile

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Which patents cover Lymphoseek Kit, 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 twenty-four patent family members in eleven countries.

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

Summary for LYMPHOSEEK KIT

International Patents:	24
US Patents:	2
Applicants:	1
NDAs:	1
Suppliers / Packagers:	2
Clinical Trials:	14
Drug Prices:	see details
DailyMed Link:	LYMPHOSEEK KIT at DailyMed

US Patents and Regulatory Information for 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
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

Non-Orange Book US Patents for LYMPHOSEEK KIT

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No.	Title	Estimated Patent Expiration
8,545,808	Compositions for radiolabeling diethylenetriaminepentaacetic acid (DTPA)-dextran

International Patents for LYMPHOSEEK KIT

Country	Document Number	Estimated Expiration
Australia	2010208624
World Intellectual Property Organization (WIPO)	0069473
Japan	2007332380
Japan	2017066148

Supplementary Protection Certificates for LYMPHOSEEK KIT

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
C0033	France		PRODUCT NAME: TILMANOCEPT; REGISTRATION NO/DATE: EU/1/14/955 20141121
90025-1	Sweden		PRODUCT NAME: TILMANOCEPT; REG. NO/DATE: EU/1/14/955 20141120
0736	Netherlands		PRODUCT NAME: TILMANOCEPT, DESGEWENST GELABELD MET TECHNETIUM TC 99M; REGISTRATION NO/DATE: EU/1/14/955 20141119