Details for New Drug Application (NDA): 021064
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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 six patents protecting this drug. Additional details are available on the DEFINITY RT profile page.
The generic ingredient in DEFINITY RT is perflutren. One supplier is listed for this compound. Additional details are available on the perflutren profile page.
The generic ingredient in DEFINITY RT is perflutren. 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: | 6 |
| Formulation / Manufacturing: | see details |
DrugPatentWatch® Estimated 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 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 | 6.52MG/ML | ||||
| Approval Date: | Jul 31, 2001 | TE: | RLD: | Yes | |||||
| Patent: | See Plans and Pricing | 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: | See Plans and Pricing | 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: | See Plans and Pricing | 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 | See Plans and Pricing | See Plans and Pricing |
| Lantheus Medcl | DEFINITY | perflutren | INJECTABLE;INTRAVENOUS | 021064-001 | Jul 31, 2001 | See Plans and Pricing | See Plans and Pricing |
| Lantheus Medcl | DEFINITY | perflutren | INJECTABLE;INTRAVENOUS | 021064-001 | Jul 31, 2001 | See Plans and Pricing | See Plans and Pricing |
| Lantheus Medcl | DEFINITY | perflutren | INJECTABLE;INTRAVENOUS | 021064-001 | Jul 31, 2001 | See Plans and Pricing | See Plans and Pricing |
| Lantheus Medcl | DEFINITY | perflutren | INJECTABLE;INTRAVENOUS | 021064-001 | Jul 31, 2001 | See Plans and Pricing | See Plans and Pricing |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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