Details for New Drug Application (NDA): 021064

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

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

Summary for 021064

Tradename:	DEFINITY
Applicant:	Lantheus Medcl
Ingredient:	perflutren
Patents:	4
Formulation / Manufacturing:	see details

Generic Entry Opportunity Date for 021064

Generic Entry Date for 021064^: ➤ Sign Up* Constraining patent/regulatory exclusivity: ➤ Sign Up 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	perflutren	INJECTABLE;INTRAVENOUS	021064	NDA	Lantheus Medical Imaging, Inc.	11994-011	11994-011-04	4 VIAL, GLASS in 1 CARTON (11994-011-04) > 1.5 mL in 1 VIAL, GLASS

Profile for product number 001

Active Rx/OTC/Discontinued:	RX	Dosage:	INJECTABLE;INTRAVENOUS			Strength	6.52MG/ML
Approval Date:	Jul 31, 2001	TE:		RLD:	Yes
Patent:	➤ Sign Up	Patent Expiration:	Jun 18, 2019	Product Flag?	Y	Substance Flag?		Delist Request?
Patent:	➤ Sign Up	Patent Expiration:	Jan 13, 2019	Product Flag?		Substance Flag?		Delist Request?
Patented Use:	METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
Patent:	➤ Sign Up	Patent Expiration:	Jan 13, 2019	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

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

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