Perflutren - Generic Drug Details

What are the generic sources for perflutren and what is the scope of freedom to operate?

Perflutren is the generic ingredient in two branded drugs marketed by Lantheus Medcl and is included in one NDA. There are ten patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Perflutren has seventy-two patent family members in seventeen countries.

One supplier is listed for this compound.

Summary for perflutren

International Patents:	72
US Patents:	10
Tradenames:	2
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	70
Clinical Trials:	26
Patent Applications:	5,934
What excipients (inactive ingredients) are in perflutren?	perflutren excipients list
DailyMed Link:	perflutren at DailyMed

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for perflutren

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 perflutren

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

Sponsor	Phase
Thomas Jefferson University	Phase 3
Thomas Jefferson University	Phase 2
UNC Lineberger Comprehensive Cancer Center	Phase 2

See all perflutren clinical trials

Pharmacology for perflutren

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

US Patents and Regulatory Information for perflutren

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 RT	perflutren	INJECTABLE;INTRAVENOUS	021064-002	Nov 17, 2020		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 perflutren

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

EU/EMA Drug Approvals for perflutren

Company	Drugname	Inn	Product Number / Indication	Status	Generic	Biosimilar	Orphan	Marketing Authorisation	Marketing Refusal
Lantheus EU Limited	Luminity	perflutren	EMEA/H/C/000654 This medicinal product is for diagnostic use only.Luminity is an ultrasound contrast-enhancing agent for use in patients in whom non-contrast echocardiography was suboptimal (suboptimal is considered to indicate that at least two of six segments in the 4- or 2-chamber view of the ventricular border were not evaluable) and who have suspected or established coronary artery disease, to provide opacification of cardiac chambers and improvement of left ventricular endocardial border delineation at both rest and stress.	Authorised	no	no	no	2006-09-20
GE Healthcare AS	Optison	perflutren	EMEA/H/C/000166 This medicinal product is for diagnostic use only.Optison is a transpulmonary echocardiographic contrast agent for use in patients with suspected or established cardiovascular disease to provide opacification of cardiac chambers, enhance left-ventricular-endocardial-border delineation with resulting improvement in wall-motion visualisation.Optison should only be used in patients where the study without contrast enhancement is inconclusive.	Authorised	no	no	no	1998-05-17

International Patents for perflutren

Country	Patent Number	Title	Estimated Expiration
China	113289034	脂质封装的气体微球组合物及相关方法 (Lipid-encapsulated gas microsphere compositions and related methods)
Canada	3022698	METHODES ET DISPOSITIFS DE PREPARATION D'AGENTS DE CONTRASTE ULTRASONORES (METHODS AND DEVICES FOR PREPARATION OF ULTRASOUND CONTRAST AGENTS)
Eurasian Patent Organization	201791437	КОМПОЗИЦИИ МИКРОСФЕР C ИНКАПСУЛИРОВАННЫМ В ЛИПИДЕ ГАЗОМ И СООТВЕТСТВУЮЩИЕ СПОСОБЫ
China	107206111	脂质封装的气体微球组合物及相关方法 (Lipid-encapsulated gas microsphere compositions and related methods)

Supplementary Protection Certificates for perflutren

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
0712293	0790017-8	Sweden		PRODUCT NAME: LIPIDMIKROSFAERER INNEHALLANDE PERFLUTREN; REG. NO/DATE: EU/1/06/361/001 20060920
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