Details for New Drug Application (NDA): 215842
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NDA 215842 describes RIVFLOZA, which is a drug marketed by Novo 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 RIVFLOZA profile page.
The generic ingredient in RIVFLOZA is nedosiran sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the nedosiran sodium profile page.
The generic ingredient in RIVFLOZA is nedosiran sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the nedosiran sodium profile page.
Summary for 215842
| Tradename: | RIVFLOZA |
| Applicant: | Novo |
| Ingredient: | nedosiran sodium |
| Patents: | 6 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 215842
Generic Entry Date for 215842*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;INJECTION |
*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: 215842
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| RIVFLOZA | nedosiran sodium | SOLUTION;INJECTION | 215842 | NDA | Novo Nordisk | 0169-5306 | 0169-5306-10 | 1 SYRINGE in 1 CARTON (0169-5306-10) / 1 mL in 1 SYRINGE |
| RIVFLOZA | nedosiran sodium | SOLUTION;INJECTION | 215842 | NDA | Novo Nordisk | 0169-5307 | 0169-5307-08 | 1 SYRINGE in 1 CARTON (0169-5307-08) / .8 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;INJECTION | Strength | EQ 80MG BASE/0.5ML (EQ 160MG BASE/ML) | ||||
| Approval Date: | Sep 29, 2023 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Sep 29, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Mar 27, 2028 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Mar 27, 2032 | ||||||||
| Regulatory Exclusivity Use: | TO LOWER URINARY OXALATE LEVELS IN CHILDREN 2 TO LESS THAN 9 YEARS OF AGE WITH PRIMARY HYPEROXALURIA TYPE 1 (PH1) AND RELATIVELY PRESERVED KIDNEY FUNCTION, E.G., EGFR GREATER THAN OR EQUAL TO 30 ML/MIN/1.73 M2 | ||||||||
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