Details for New Drug Application (NDA): 219947
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NDA 219947 describes REDEMPLO, which is a drug marketed by Arrowhead and is included in one NDA. It is available from one supplier. There are five patents protecting this drug. Additional details are available on the REDEMPLO profile page.
The generic ingredient in REDEMPLO is plozasiran sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the plozasiran sodium profile page.
The generic ingredient in REDEMPLO is plozasiran sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the plozasiran sodium profile page.
Summary for 219947
| Tradename: | REDEMPLO |
| Applicant: | Arrowhead |
| Ingredient: | plozasiran sodium |
| Patents: | 5 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219947
Generic Entry Date for 219947*:
Constraining patent/regulatory exclusivity:
Dosage:
SOLUTION;SUBCUTANEOUS |
*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: 219947
| Physiological Effect | Increased RNA Degradation |
Suppliers and Packaging for NDA: 219947
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| REDEMPLO | plozasiran sodium | SOLUTION;SUBCUTANEOUS | 219947 | NDA | Arrowhead Pharmaceuticals, Inc. | 84141-025 | 84141-025-01 | 1 SYRINGE, GLASS in 1 CARTON (84141-025-01) / 1 mL in 1 SYRINGE, GLASS |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 25MG BASE/0.5ML (EQ 25MG BASE/0.5ML) | ||||
| Approval Date: | Nov 18, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 18, 2032 | ||||||||
| Regulatory Exclusivity Use: | AS AN ADJUNCT TO DIET TO REDUCE TRIGLYCERIDES IN ADULTS WITH FAMILIAL CHYLOMICRONEMIA SYNDROME (FCS) | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Mar 7, 2037 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | USE TO REDUCE TRIGLYCERIDES IN ADULTS WITH FAMILIAL CHYLOMICRONEMIA SYNDROME (FCS) | ||||||||
| Patent: | ⤷ Start Trial | Patent Expiration: | Sep 10, 2038 | Product Flag? | Y | Substance Flag? | Y | Delist Request? | |
| Patented Use: | USE TO REDUCE TRIGLYCERIDES IN ADULTS WITH FAMILIAL CHYLOMICRONEMIA SYNDROME (FCS) | ||||||||
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