DrugPatentWatch Database Preview
Details for New Drug Application (NDA): 204781
NDA 204781 describes DOTAREM, which is a drug marketed by Guerbet and is included in one NDA. It is available from one supplier. Additional details are available on the DOTAREM profile page.
The generic ingredient in DOTAREM is gadoterate meglumine. One supplier is listed for this compound. Additional details are available on the gadoterate meglumine profile page.
The generic ingredient in DOTAREM is gadoterate meglumine. One supplier is listed for this compound. Additional details are available on the gadoterate meglumine profile page.
Summary for 204781
| Tradename: | DOTAREM |
| Applicant: | Guerbet |
| Ingredient: | gadoterate meglumine |
| Patents: | 0 |
| Formulation / Manufacturing: | see details |
Generic Entry Opportunity Date for 204781
Generic Entry Date for 204781*:
Constraining patent/regulatory exclusivity:
NEW PATIENT POPULATION Dosage:
SOLUTION;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: 204781
| Mechanism of Action | Magnetic Resonance Contrast Activity |
Suppliers and Packaging for NDA: 204781
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781 | NDA | Guerbet LLC | 67684-2000 | 67684-2000-4 | 6 VIAL in 1 PACKAGE (67684-2000-4) > 100 mL in 1 VIAL |
| DOTAREM | gadoterate meglumine | SOLUTION;INTRAVENOUS | 204781 | NDA | Guerbet LLC | 67684-2000 | 67684-2000-0 | 10 VIAL in 1 PACKAGE (67684-2000-0) > 5 mL in 1 VIAL |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 37.69GM/100ML (376.9MG/ML) | ||||
| Approval Date: | Mar 20, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 20, 2018 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Aug 25, 2020 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 3.769GM/10ML (376.9MG/ML) | ||||
| Approval Date: | Mar 20, 2013 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 20, 2018 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
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