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Details for New Drug Application (NDA): 021064
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.
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*:
Constraining patent/regulatory exclusivity:
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: | Start Trial | Patent Expiration: | Jun 18, 2019 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | Start Trial | 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: | Start Trial | 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
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Lantheus Medcl | DEFINITY | perflutren | INJECTABLE;INTRAVENOUS | 021064-001 | Jul 31, 2001 | Start Trial | Start Trial |
| Lantheus Medcl | DEFINITY | perflutren | INJECTABLE;INTRAVENOUS | 021064-001 | Jul 31, 2001 | Start Trial | Start Trial |
| Lantheus Medcl | DEFINITY | perflutren | INJECTABLE;INTRAVENOUS | 021064-001 | Jul 31, 2001 | Start Trial | Start Trial |
| Lantheus Medcl | DEFINITY | perflutren | INJECTABLE;INTRAVENOUS | 021064-001 | Jul 31, 2001 | Start Trial | Start Trial |
| Lantheus Medcl | DEFINITY | perflutren | INJECTABLE;INTRAVENOUS | 021064-001 | Jul 31, 2001 | Start Trial | Start Trial |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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