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DEFINITY Drug Profile

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Definity 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.

This drug has sixty-nine patent family members in twenty-nine countries.

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 Tradename: DEFINITY

Patents:3
Applicants:1
NDAs:1
Suppliers / Packagers: see list1

Pharmacology for Tradename: DEFINITY

Clinical Trials for: DEFINITY

Applicant Tradename Generic Name Dosage NDA Approval Date Type RLD Patent No. Patent Expiration Product Substance Delist Req. Exclusivity Expiration
Lantheus Medcl
DEFINITY
perflutren
INJECTABLE;INTRAVENOUS021064-001Jul 31, 2001RXYes6,033,645<disabled> <disabled>
Lantheus Medcl
DEFINITY
perflutren
INJECTABLE;INTRAVENOUS021064-001Jul 31, 2001RXYes8,685,441<disabled> <disabled>
Lantheus Medcl
DEFINITY
perflutren
INJECTABLE;INTRAVENOUS021064-001Jul 31, 2001RXYes8,658,205<disabled>Y <disabled>
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Expired Patents for Tradename: DEFINITY

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Applicant Tradename Generic Name Dosage NDA Approval Date Patent No. Patent Expiration
Lantheus Medcl
DEFINITY
perflutren
INJECTABLE;INTRAVENOUS021064-001Jul 31, 20016,773,696<disabled>
Lantheus Medcl
DEFINITY
perflutren
INJECTABLE;INTRAVENOUS021064-001Jul 31, 20015,527,521<disabled>
Lantheus Medcl
DEFINITY
perflutren
INJECTABLE;INTRAVENOUS021064-001Jul 31, 20016,033,645<disabled>
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Non-Orange Book Patents for Tradename: DEFINITY

For Orange Book-listed patents (shown in the main table above) generic applications must certify that the listed patents are expired, invalid, or will not be infringed by generic entry.

The non-Orange Book patents listed below do not require formal certifications, so they do not automatically impede generic entry. Instead, they represent potential opportunities for branded firms to block generic entry through patent infringment challenges.

Patent No. Title Estimated Patent Expiration
6,139,819 Targeted contrast agents for diagnostic and therapeutic use<disabled in preview>
8,084,056Preparation of a lipid blend and a phospholipid suspension containing the lipid blend<disabled in preview>
6,521,211 Methods of imaging and treatment with targeted compositions<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Because of the complexity of determining patent expiration dates it is advisable to have patent counsel verify freedom to operate.

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International Patent Family for Tradename: DEFINITY

Country Document Number Estimated Expiration
Japan5160702<disabled in preview>
Australia3586600<disabled in preview>
World Intellectual Property Organization (WIPO)9748337<disabled in preview>
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The estimated expiration dates shown above are derived by simply adding 20 years to the priority date.
Due to the complexity of determining patent expirations even in a single country, compounded by the diversity of global patent laws, it is advisable to have patent counsel verify freedom to operate.

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Supplementary Protection Certificates for Tradename: DEFINITY

Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
90017-8Sweden<disabled>PRODUCT NAME: LIPIDMIKROSFAERER INNEHALLANDE PERFLUTREN; REG. NO/DATE: EU/1/06/361/001 20060920
00267Netherlands<disabled>PRODUCT NAME: PERFLUTREN BEVATTENDE LIPIDE-MICROBOLLEN; REGISTRATION NO/DATE: EU/1/06/361/001 20060920
C/GB07/031United Kingdom<disabled>PRODUCT NAME: PERFLUTREN-CONTAINING LIPID MICROSPHERES; REGISTERED: UK EU/1/06/361/001 20060920
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