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DEFINITY Drug Profile

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Which patents cover Definity, and what generic alternatives are available?

Definity is a drug marketed by Lantheus Medcl and is included in one NDA. There are four patents protecting this drug.

This drug has thirty-eight patent family members in thirteen countries.

The generic ingredient in DEFINITY is perflutren. One supplier is listed for this compound. Additional details are available on the perflutren profile page.

US ANDA Litigation and Generic Entry Outlook for Definity

Definity was eligible for patent challenges on July 31, 2005.

By analyzing the patents and regulatory protections it appears that the earliest date for generic entry will be May 4, 2037. This may change due to patent challenges or generic licensing.

Indicators of Generic Entry

Summary for DEFINITY

International Patents:	38
US Patents:	4
Applicants:	1
NDAs:	1
Suppliers / Packagers:	1
Bulk Api Vendors:	34
Clinical Trials:	50
Patent Applications:	1,497
Formulation / Manufacturing:	see details
Drug Prices:	Drug price information for DEFINITY
DailyMed Link:	DEFINITY at DailyMed

See drug prices for DEFINITY

Generic Entry Opportunity Date for DEFINITY

NDA:

021064

Dosage:

INJECTABLE;INTRAVENOUS

^*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 DEFINITY

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

Sponsor	Phase
National Cancer Institute (NCI)	Phase 2
National Institute on Aging (NIA)	N/A
Elisa Konofagou	N/A

See all DEFINITY clinical trials

Pharmacology for DEFINITY

Drug Class	Contrast Agent for Ultrasound Imaging
Mechanism of Action	Ultrasound Contrast Activity

US Patents and Regulatory Information for DEFINITY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	TE	Type	RLD	RS	Patent No.	Patent Expiration	Product	Substance	Delist Req.	Exclusivity Expiration
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001		RX	Yes	Yes

Expired US Patents for DEFINITY

Applicant	Tradename	Generic Name	Dosage	NDA	Approval Date	Patent No.	Patent Expiration
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001

International Patents for DEFINITY

Country	Patent Number	Estimated Expiration
Canada	2188557
Brazil	9609343
China	1102045
Hong Kong	1010127
Portugal	788348
World Intellectual Property Organization (WIPO)	9428874

Supplementary Protection Certificates for DEFINITY

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0712293	SPC018/2007	Ireland		SPC018/2007: 20071012, EXPIRES: 20190519
0712293	C300267	Netherlands		PRODUCT NAME: PERFLUTREN BEVATTENDE LIPIDE-MICROBOLLEN; REGISTRATION NO/DATE: EU/1/06/361/001 20060920
0712293	SPC/GB07/031	United Kingdom		PRODUCT NAME: PERFLUTREN-CONTAINING LIPID MICROSPHERES; REGISTERED: UK EU/1/06/361/001 20060920
0712293	CA 2007 00027	Denmark
0712293	300267	Netherlands		300267, 20140520, EXPIRES: 20190519
0712293	91325	Luxembourg		PRODUCT NMAE. LUMINITY; REGISTRATION DATE: 20060920