Details for New Drug Application (NDA): 203684
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NDA 203684 describes LUMASON, which is a drug marketed by Bracco 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 LUMASON profile page.
The generic ingredient in LUMASON is sulfur hexafluoride lipid-type a microspheres. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sulfur hexafluoride lipid-type a microspheres profile page.
The generic ingredient in LUMASON is sulfur hexafluoride lipid-type a microspheres. There are two drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the sulfur hexafluoride lipid-type a microspheres profile page.
Summary for 203684
| Tradename: | LUMASON |
| Applicant: | Bracco |
| Ingredient: | sulfur hexafluoride lipid-type a microspheres |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 203684
*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: 203684
| Mechanism of Action | Ultrasound Contrast Activity |
Suppliers and Packaging for NDA: 203684
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| LUMASON | sulfur hexafluoride lipid-type a microspheres | FOR SUSPENSION;INTRAVENOUS | 203684 | NDA | BRACCO DIAGNOSTICS INC | 0270-7097 | 0270-7097-08 | 20 VIAL in 1 BOX (0270-7097-08) / 25 mg in 1 VIAL |
| LUMASON | sulfur hexafluoride lipid-type a microspheres | FOR SUSPENSION;INTRAVENOUS | 203684 | NDA | BRACCO DIAGNOSTICS INC | 0270-7097 | 0270-7097-07 | 20 VIAL in 1 BOX (0270-7097-07) / 25 mg in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | FOR SUSPENSION;INTRAVENOUS | Strength | 60.7MG/25MG | ||||
| Approval Date: | Oct 15, 2014 | TE: | RLD: | Yes | |||||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 6, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | Jul 6, 2038 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patent: | ⤷ Sign Up | Patent Expiration: | May 15, 2039 | Product Flag? | Y | Substance Flag? | Delist Request? | ||
| Patented Use: | USE IN ADULT AND PEDIATRIC PATIENTS WITH SUBOPTIMAL ECHOCARDIOGRAMS TO OPACIFY THE LEFT VENTRICULAR CHAMBER AND TO IMPROVE THE DELINEATION OF THE LEFT VENTRICULAR ENDOCARDIAL BORDER | ||||||||
Expired US Patents for NDA 203684
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
|---|---|---|---|---|---|---|---|
| Bracco | LUMASON | sulfur hexafluoride lipid-type a microspheres | FOR SUSPENSION;INTRAVENOUS | 203684-001 | Oct 15, 2014 | ⤷ Sign Up | ⤷ Sign Up |
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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