Details for New Drug Application (NDA): 021064

NDA 021064 describes DEFINITY RT, which is a drug marketed by Lantheus Medcl and is included in one NDA. It is available from one supplier. There are eleven patents protecting this drug. Additional details are available on the DEFINITY RT profile page.

The generic ingredient in DEFINITY RT is perflutren. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the perflutren profile page.

Summary for 021064

Tradename:	DEFINITY RT
Applicant:	Lantheus Medcl
Ingredient:	perflutren
Patents:	11

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

Pharmacology for NDA: 021064

Mechanism of Action

Ultrasound Contrast Activity

Suppliers and Packaging for NDA: 021064

Tradename	Generic Name	Dosage	NDA	Application Type	Supplier	National Drug Code	Package Code	Package
DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064	NDA	Lantheus Medical Imaging, Inc.	11994-011	11994-011-01	1 VIAL, GLASS in 1 CARTON (11994-011-01) / 1.5 mL in 1 VIAL, GLASS
DEFINITY RT	perflutren	INJECTABLE;INTRAVENOUS	021064	NDA	Lantheus Medical Imaging, Inc.	11994-011	11994-011-01	1 VIAL, GLASS in 1 CARTON (11994-011-01) / 1.5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	13.04MG/2ML (6.52MG/ML)
Approval Date:	Jul 31, 2001	TE:		RLD:	Yes
Patent:		Patent Expiration:	Dec 28, 2035	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
Patent:		Patent Expiration:	Mar 16, 2037	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
Patent:		Patent Expiration:	May 4, 2037	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING

Expired US Patents for NDA 021064

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
Lantheus Medcl	DEFINITY	perflutren	INJECTABLE;INTRAVENOUS	021064-001	Jul 31, 2001

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