Details for New Drug Application (NDA): 219019
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NDA 219019 describes QFITLIA, which is a drug marketed by Genzyme Corp 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 QFITLIA profile page.
The generic ingredient in QFITLIA is fitusiran sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fitusiran sodium profile page.
The generic ingredient in QFITLIA is fitusiran sodium. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the fitusiran sodium profile page.
Summary for 219019
| Tradename: | QFITLIA |
| Applicant: | Genzyme Corp |
| Ingredient: | fitusiran sodium |
| Patents: | 3 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219019
Generic Entry Date for 219019*:
Constraining patent/regulatory exclusivity:
ROUTINE PROPHYLAXIS TO PREVENT OR REDUCE THE FREQUENCY OF BLEEDING EPISODES IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HEMOPHILIA B WITH OR WITHOUT FACTOR IX INHIBITORS 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: 219019
| Physiological Effect | Decreased RNA Integrity Increased RNA Degradation |
Suppliers and Packaging for NDA: 219019
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| QFITLIA | fitusiran sodium | SOLUTION;SUBCUTANEOUS | 219019 | NDA | Genzyme Corporation | 58468-0347 | 58468-0347-1 | 1 VIAL in 1 CARTON (58468-0347-1) / .2 mL in 1 VIAL |
| QFITLIA | fitusiran sodium | SOLUTION;SUBCUTANEOUS | 219019 | NDA | Genzyme Corporation | 58468-0348 | 58468-0348-1 | 1 SYRINGE in 1 CARTON (58468-0348-1) / .5 mL in 1 SYRINGE |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | SOLUTION;SUBCUTANEOUS | Strength | EQ 20MG BASE/0.2ML (EQ 20MG BASE/0.2ML) | ||||
| Approval Date: | Mar 28, 2025 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Mar 28, 2030 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Mar 28, 2032 | ||||||||
| Regulatory Exclusivity Use: | ROUTINE PROPHYLAXIS TO PREVENT OR REDUCE THE FREQUENCY OF BLEEDING EPISODES IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HEMOPHILIA A WITH OR WITHOUT FACTOR VIII INHIBITORS | ||||||||
| Regulatory Exclusivity Expiration: | Mar 28, 2032 | ||||||||
| Regulatory Exclusivity Use: | ROUTINE PROPHYLAXIS TO PREVENT OR REDUCE THE FREQUENCY OF BLEEDING EPISODES IN ADULT AND PEDIATRIC PATIENTS AGED 12 YEARS AND OLDER WITH HEMOPHILIA B WITH OR WITHOUT FACTOR IX INHIBITORS | ||||||||
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