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Last Updated: March 28, 2024

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 four patents protecting this drug. Additional details are available on the VOXZOGO profile page.

The generic ingredient in VOXZOGO is vosoritide. 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:4
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for 214938
Generic Entry Date for 214938*:
Constraining patent/regulatory exclusivity:
TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS LESS THAN 5 YEARS OF AGE 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: 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:RXDosage:POWDER;SUBCUTANEOUSStrength0.4MG/VIAL
Approval Date:Nov 19, 2021TE: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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