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Serving 500+ biopharmaceutical companies globally:

McKinsey
Queensland Health
Julphar
Novartis
McKesson
Deloitte
Cantor Fitzgerald
Covington
Fuji
UBS

Generated: August 23, 2017

DrugPatentWatch Database Preview

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 three 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 NDA: 021064

Tradename:
1
Applicant:
1
Ingredient:
1
Patents:3
Formulation / Manufacturing:see details

Pharmacology for NDA: 021064

Mechanism of ActionUltrasound 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

Summary for product number 001

Active Rx/OTC/Discontinued:RXDosage:INJECTABLE;INTRAVENOUSStrength6.52MG/ML
Approval Date:Jul 31, 2001TE:RLD:Yes
Patent:► SubscribePatent Expiration:Jun 18, 2019Product Flag?YSubstance Flag?Delist Request?
Patent:► SubscribePatent Expiration:Jan 13, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
Patent:► SubscribePatent Expiration:Jan 13, 2019Product Flag?Substance Flag?Delist Request?
Patented Use:METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING

Expired Orange Book Patents for NDA: 021064

Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lantheus Medcl
DEFINITY
perflutren
INJECTABLE;INTRAVENOUS021064-001Jul 31, 2001► Subscribe► Subscribe
Lantheus Medcl
DEFINITY
perflutren
INJECTABLE;INTRAVENOUS021064-001Jul 31, 2001► Subscribe► Subscribe
Lantheus Medcl
DEFINITY
perflutren
INJECTABLE;INTRAVENOUS021064-001Jul 31, 2001► Subscribe► Subscribe
Lantheus Medcl
DEFINITY
perflutren
INJECTABLE;INTRAVENOUS021064-001Jul 31, 2001► Subscribe► Subscribe
Lantheus Medcl
DEFINITY
perflutren
INJECTABLE;INTRAVENOUS021064-001Jul 31, 2001► Subscribe► Subscribe
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Serving 500+ biopharmaceutical companies globally:

Deloitte
Cerilliant
Mallinckrodt
Covington
Colorcon
Healthtrust
Argus Health
Chinese Patent Office
Novartis
Baxter

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