Details for New Drug Application (NDA): 216986
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NDA 216986 describes ELUCIREM, which is a drug marketed by Guerbet and is included in one NDA. It is available from two suppliers. There are four patents protecting this drug. Additional details are available on the ELUCIREM profile page.
The generic ingredient in ELUCIREM is gadopiclenol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the gadopiclenol profile page.
The generic ingredient in ELUCIREM is gadopiclenol. There is one drug master file entry for this compound. Two suppliers are listed for this compound. Additional details are available on the gadopiclenol profile page.
Summary for 216986
| Tradename: | ELUCIREM |
| Applicant: | Guerbet |
| Ingredient: | gadopiclenol |
| Patents: | 4 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 216986
Generic Entry Date for 216986*:
Constraining patent/regulatory exclusivity:
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.
Suppliers and Packaging for NDA: 216986
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| ELUCIREM | gadopiclenol | SOLUTION;INTRAVENOUS | 216986 | NDA | BRACCO DIAGNOSTICS INC | 0270-7015 | 0270-7015-46 | 25 VIAL, PHARMACY BULK PACKAGE in 1 CASE (0270-7015-46) / 30 mL in 1 VIAL, PHARMACY BULK PACKAGE |
| ELUCIREM | gadopiclenol | SOLUTION;INTRAVENOUS | 216986 | NDA | BRACCO DIAGNOSTICS INC | 0270-7015 | 0270-7015-48 | 25 VIAL, PHARMACY BULK PACKAGE in 1 CASE (0270-7015-48) / 50 mL in 1 VIAL, PHARMACY BULK PACKAGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 1.4553GM/3ML (485.1MG/ML) | ||||
| Approval Date: | Sep 21, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 21, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Feb 20, 2029 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Patent: | 10,973,934 | Patent Expiration: | Aug 6, 2039 | Product Flag? | Substance Flag? | Y | Delist Request? | ||
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