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Generic Voxzogo Availability

Last updated on Mar 9, 2023.

Voxzogo is a brand name of vosoritide, approved by the FDA in the following formulation(s):

VOXZOGO (vosoritide - powder;subcutaneous)

  • Manufacturer: BIOMARIN PHARM
    Approval date: November 19, 2021
    Strength(s): 0.4MG/VIAL [RLD], 0.56MG/VIAL [RLD], 1.2MG/VIAL [RLD]

Has a generic version of Voxzogo been approved?

No. There is currently no therapeutically equivalent version of Voxzogo available in the United States.

Note: Fraudulent online pharmacies may attempt to sell an illegal generic version of Voxzogo. These medications may be counterfeit and potentially unsafe. If you purchase medications online, be sure you are buying from a reputable and valid online pharmacy. Ask your health care provider for advice if you are unsure about the online purchase of any medication.

See also: Generic Drug FAQ.

Related patents

Patents are granted by the U.S. Patent and Trademark Office at any time during a drug's development and may include a wide range of claims.

  • Patent 10,646,550

    Patent expiration dates:

    • August 1, 2036
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      Patent use: USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES
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      Drug product
  • Variants of C-type natriuretic peptide
    Patent 8,198,242
    Issued: June 12, 2012
    Inventor(s): Wendt; Daniel J. & Long; Shinong & Castillo; Sianna & Price; Christopher P. & Aoyagi-Scharber; Mika & Vellard; Michel C. & Okhamafe; Augustus O.
    Assignee(s): Biomarin Pharmaceutical Inc.

    The present disclosure provides variants of C-type natriuretic peptide (CNP), pharmaceutical compositions comprising CNP variants, and methods of making CNP variants. The CNP variants are useful as therapeutic agents for the treatment of diseases responsive to CNP, including but not limited to bone-related disorders, such as skeletal dysplasias (e.g., achondroplasia), and vascular smooth muscle disorders (e.g., restenosis and arteriosclerosis).

    Patent expiration dates:

    • June 11, 2030
      ✓ 
      Patent use: USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES
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      Drug substance
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      Drug product
  • Use of C-type natriuretic peptide variants to treat skeletal dysplasia
    Patent 9,907,834
    Issued: March 6, 2018
    Assignee(s): BioMarin Pharmaceutical Inc.

    The present disclosure provides for use of variants of C-type natriuretic peptide (CNP), and novel pharmaceutical compositions and formulations comprising CNP variant peptides for the treatment of skeletal dysplasias, one or more symptoms of skeletal dysplasias, such as long bone growth or growth velocity, and other disorders having a skeletal dysplasia and/or CNP-associated symptom or component.

    Patent expiration dates:

    • August 1, 2036
      ✓ 
      Drug product
  • Patent RE48267

    Patent expiration dates:

    • May 20, 2030
      ✓ 
      Patent use: USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES

Related exclusivities

Exclusivity is exclusive marketing rights granted by the FDA upon approval of a drug and can run concurrently with a patent or not. Exclusivity is a statutory provision and is granted to an NDA applicant if statutory requirements are met.

  • Exclusivity expiration dates:

    • November 19, 2026 - NEW CHEMICAL ENTITY
    • November 19, 2028 - TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES

Glossary

Term Definition
Drug Patent A drug patent is assigned by the U.S. Patent and Trademark Office and assigns exclusive legal right to the patent holder to protect the proprietary chemical formulation. The patent assigns exclusive legal right to the inventor or patent holder, and may include entities such as the drug brand name, trademark, product dosage form, ingredient formulation, or manufacturing process A patent usually expires 20 years from the date of filing, but can be variable based on many factors, including development of new formulations of the original chemical, and patent infringement litigation.
Drug Exclusivity Exclusivity is the sole marketing rights granted by the FDA to a manufacturer upon the approval of a drug and may run simultaneously with a patent. Exclusivity periods can run from 180 days to seven years depending upon the circumstance of the exclusivity grant.
RLD A Reference Listed Drug (RLD) is an approved drug product to which new generic versions are compared to show that they are bioequivalent. A drug company seeking approval to market a generic equivalent must refer to the Reference Listed Drug in its Abbreviated New Drug Application (ANDA). By designating a single reference listed drug as the standard to which all generic versions must be shown to be bioequivalent, FDA hopes to avoid possible significant variations among generic drugs and their brand name counterpart.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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