Details for New Drug Application (NDA): 215833
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NDA 215833 describes PLUVICTO, which is a drug marketed by Novartis 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 PLUVICTO profile page.
The generic ingredient in PLUVICTO is lutetium lu-177 vipivotide tetraxetan. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lutetium lu-177 vipivotide tetraxetan profile page.
The generic ingredient in PLUVICTO is lutetium lu-177 vipivotide tetraxetan. There are four drug master file entries for this compound. One supplier is listed for this compound. Additional details are available on the lutetium lu-177 vipivotide tetraxetan profile page.
Summary for 215833
| Tradename: | PLUVICTO |
| Applicant: | Novartis |
| Ingredient: | lutetium lu-177 vipivotide tetraxetan |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215833
Generic Entry Date for 215833*:
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.
Pharmacology for NDA: 215833
| Mechanism of Action | Radioligand Activity |
Suppliers and Packaging for NDA: 215833
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| PLUVICTO | lutetium lu-177 vipivotide tetraxetan | SOLUTION;INTRAVENOUS | 215833 | NDA | Advanced Accelerator Applications USA, Inc | 69488-010 | 69488-010-61 | 1 VIAL, GLASS in 1 PACKAGE (69488-010-61) / 7.5 mL in 1 VIAL, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INTRAVENOUS | Strength | 27mCi/ML | ||||
| Approval Date: | Mar 23, 2022 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 23, 2027 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Patent: | ⤷ Try a Trial | Patent Expiration: | Oct 17, 2034 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patent: | ⤷ Try a Trial | Patent Expiration: | Aug 15, 2028 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | FOR TREATMENT OF ADULT PATIENTS WITH PROSTATE-SPECIFIC MEMBRANE ANTIGEN (PSMA)-POSITIVE METASTATIC CASTRATION-RESISTANT PROSTATE CANCER (MCRPC) WHO HAVE BEEN TREATED WITH ANDROGEN RECEPTOR (AR) PATHWAY INHIBITION AND TAXANE-BASED CHEMOTHERAPY | ||||||||
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