Details for New Drug Application (NDA): 214938
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NDA 214938 describes VOXZOGO, which is a drug marketed by Biomarin Pharm and is included in one NDA. It is available from one supplier. There are eight patents protecting this drug. Additional details are available on the VOXZOGO profile page.
The generic ingredient in VOXZOGO is vosoritide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the vosoritide profile page.
The generic ingredient in VOXZOGO is vosoritide. There is one drug master file entry for this compound. One supplier is listed for this compound. Additional details are available on the vosoritide profile page.
Summary for 214938
| Tradename: | VOXZOGO |
| Applicant: | Biomarin Pharm |
| Ingredient: | vosoritide |
| Patents: | 8 |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214938
Generic Entry Date for 214938*:
Constraining patent/regulatory exclusivity:
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: 214938
| Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
|---|---|---|---|---|---|---|---|---|
| VOXZOGO | vosoritide | POWDER;SUBCUTANEOUS | 214938 | NDA | BioMarin Pharmaceutical Inc. | 68135-082 | 68135-082-36 | 1 KIT in 1 CARTON (68135-082-36) * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-061-00) / .5 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-070-12) |
| VOXZOGO | vosoritide | POWDER;SUBCUTANEOUS | 214938 | NDA | BioMarin Pharmaceutical Inc. | 68135-119 | 68135-119-66 | 1 KIT in 1 CARTON (68135-119-66) * 10 VIAL, SINGLE-DOSE in 1 CARTON (68135-094-84) / .7 mL in 1 VIAL, SINGLE-DOSE * 10 INJECTION, SOLUTION in 1 CARTON (68135-102-43) |
Profile for product number 001
| Active Rx/OTC/Discontinued: | RX | Dosage: | POWDER;SUBCUTANEOUS | Strength | 0.4MG/VIAL | ||||
| Approval Date: | Nov 19, 2021 | TE: | RLD: | Yes | |||||
| Regulatory Exclusivity Expiration: | Nov 19, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW CHEMICAL ENTITY | ||||||||
| Regulatory Exclusivity Expiration: | Oct 20, 2026 | ||||||||
| Regulatory Exclusivity Use: | NEW PATIENT POPULATION | ||||||||
| Regulatory Exclusivity Expiration: | Oct 20, 2030 | ||||||||
| Regulatory Exclusivity Use: | TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS LESS THAN 5 YEARS OF AGE WITH ACHONDROPLASIA WITH OPEN EPIPHYSES | ||||||||
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