Details for New Drug Application (NDA): 219164
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NDA 219164 describes YUVIWEL, which is a drug marketed by Ascendis and is included in one NDA. It is available from one supplier. Additional details are available on the YUVIWEL profile page.
The generic ingredient in YUVIWEL is navepegritide. One supplier is listed for this compound. Additional details are available on the navepegritide profile page.
The generic ingredient in YUVIWEL is navepegritide. One supplier is listed for this compound. Additional details are available on the navepegritide profile page.
Summary for 219164
| Tradename: | YUVIWEL |
| Applicant: | Ascendis |
| Ingredient: | navepegritide |
| Patents: | 0 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 219164
Generic Entry Date for 219164*:
Constraining patent/regulatory exclusivity:
TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH ACHONDROPLASIA WITH OPEN EPIPHYSES Dosage:
POWDER;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.
Suppliers and Packaging for NDA: 219164
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| YUVIWEL | navepegritide | POWDER;SUBCUTANEOUS | 219164 | NDA | Ascendis Pharma Endocrinology, Inc. | 73362-201 | 73362-201-01 | 4 BOX in 1 CARTON (73362-201-01) / 1 KIT in 1 BOX (73362-201-02) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (73362-205-01) * 1 SOLUTION in 1 SYRINGE, GLASS (73362-801-01) |
| YUVIWEL | navepegritide | POWDER;SUBCUTANEOUS | 219164 | NDA | Ascendis Pharma Endocrinology, Inc. | 73362-202 | 73362-202-01 | 4 BOX in 1 CARTON (73362-202-01) / 1 KIT in 1 BOX (73362-202-02) * 1 INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION in 1 VIAL, GLASS (73362-206-01) * 1 SOLUTION in 1 SYRINGE, GLASS (73362-801-01) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | 1.3MG/VIAL | ||||
| Approval Date: | Feb 27, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 27, 2033 | ||||||||
| Regulatory Exclusivity Use: | TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH ACHONDROPLASIA WITH OPEN EPIPHYSES | ||||||||
Profile for product number 002
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | 2.8MG/VIAL | ||||
| Approval Date: | Feb 27, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 27, 2033 | ||||||||
| Regulatory Exclusivity Use: | TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH ACHONDROPLASIA WITH OPEN EPIPHYSES | ||||||||
Profile for product number 003
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | 5.5MG/VIAL | ||||
| Approval Date: | Feb 27, 2026 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Feb 27, 2033 | ||||||||
| Regulatory Exclusivity Use: | TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS 2 YEARS OF AGE AND OLDER WITH ACHONDROPLASIA WITH OPEN EPIPHYSES | ||||||||
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