Voxzogo is a drug owned by Biomarin Pharmaceutical Inc. It is protected by 6 US drug patents filed from 2021 to 2024 out of which none have expired yet. Voxzogo's patents will be open to challenges from 19 November, 2025. Based on its patents and exclusivities, its generic launch date is estimated to be Aug 01, 2036. Details of Voxzogo's patents and their expiration are given in the table below.
| Drug Patent Number | Drug Patent Title | Drug Patent Expiry | Status |
|---|---|---|---|
| These drug patents protect the active ingredient(API) of the drug. Only drug patent owner can launch products that use this active ingredient until these patents expire. | |||
| US8198242 | Variants of C-type natriuretic peptide |
Jun, 2030
(5 years from now) | Active |
| These drug patents focus on the other aspects of the drug like dosage, mode of administration (oral, tablet, capsules, liquids etc). | |||
| US10646550 | Use of C-type natriuretic peptide variants to treat skeletal dysplasia |
Aug, 2036
(11 years from now) | Active |
| US9907834 | Use of C-type natriuretic peptide variants to treat skeletal dysplasia |
Aug, 2036
(11 years from now) | Active |
| US11911446 | Use of C-type natriuretic peptide variants to treat skeletal dysplasia |
Aug, 2036
(11 years from now) | Active |
| US11590204 | Use of C-type natriuretic peptide variants to treat skeletal dysplasia |
Aug, 2036
(11 years from now) | Active |
| USRE48267 | Variants of C-type natriuretic peptide |
May, 2030
(5 years from now) | Active |
A patent's expiry date may change depending upon legal activities going on that patent. Critical activities like abandoning of a patent, term extension of a patent or amendment of its claims can increase or decrease the life of a patent hence affecting its expiry date and in turn affecting the generic launch date of that drug. Tracking these ongoing activities on a patent application helps to keep an eye on the latest developments in the patent process of the drug which can give an idea of how early a drug's generic could be available. The next section provides a list of recent legal activities on Voxzogo's patents.
Latest Legal Activities on Voxzogo's Patents
Given below is the list of recent legal activities going on the following patents of Voxzogo.
| Activity | Date | Patent Number |
|---|---|---|
 | ||
| transaction for FDA Determination of Regulatory Review Period | 04 Mar, 2024 | US8198242 |
| transaction for FDA Determination of Regulatory Review Period | 28 Feb, 2024 | US8198242 |
| Second letter to regulating agency to determine regulatory review period | 05 Jan, 2024 | US8198242 |
| Payment of Maintenance Fee, 12th Year, Large Entity | 21 Nov, 2023 | US8198242 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 19 Oct, 2023 | US10646550 |
| Letter from FDA or Dept of Agriculture re PTE application | 28 Sep, 2023 | US8198242 |
| Initial letter Re: PTE Application to regulating agency | 03 Aug, 2022 | US8198242 |
| Payment of Maintenance Fee, 4th Year, Large Entity | 07 Sep, 2021 | US9907834 |
| Post Issue Communication - Certificate of Correction | 21 Jan, 2021 | US10646550 |
| Sequence Moved to Public Database | 17 May, 2020 | US10646550 |
FDA has granted several exclusivities to Voxzogo. Till the time these exclusivities are active, no other company can market a generic or bioequivalent version of Voxzogo, regardless of the status of it's patents. These exclusivities hence play a crucial role in delaying the generic launch. Given below are details of the exclusivities granted to Voxzogo.
Exclusivity Information
Voxzogo holds 4 exclusivities out of which none have expired. Its last outstanding exclusivity is set to expire in 2030. Details of Voxzogo's exclusivity codes and their expiration dates are given below.
| Drug Exclusivity | Drug Exclusivity Expiration |
|---|---|
| New Patient Population(NPP) | Oct 20, 2026 |
| New Chemical Entity Exclusivity(NCE) | Nov 19, 2026 |
| Orphan Drug Exclusivity(ODE-387) | Nov 19, 2028 |
| Orphan Drug Exclusivity(ODE-449) | Oct 20, 2030 |
Several oppositions have been filed on Voxzogo's European patents. EP oppositions can significantly impact the timeline for the generic launch of drugs. If an opposition results in the revocation or amendment of a patent, it can shorten the exclusivity period of the original drug. This can lead to an earlier entry of generic versions into the market. To help you estimate the potential early arrival of Voxzogo's generic, the next section provides detailed information on ongoing and past EP oppositions related to Voxzogo patents.
Voxzogo's Oppositions Filed in EPO
Voxzogo has faced multiple oppositions in the European Patent Office. The earliest opposition was filed on Sep 01, 2022, by Ascendis Pharma Growth Disorders A/S. This opposition was filed on patent number EP16192229A. Click below to reveal the latest opposition data.
| Application | Filing Date | Opposition Party | Legal Status |
|---|---|---|---|
 | |||
| EP16192229A | Sep, 2022 | Ascendis Pharma Growth Disorders A/S | Granted and Under Opposition |
US patents provide insights into the exclusivity only within the United States, but Voxzogo is protected by patents in multiple countries. Understanding the full scope of patent protection is crucial in strategizing market entry. By looking at the broader patent landscape, you can identify markets with weaker patent protection which could be ideal generic entry points. The following section offers details on Voxzogo's family patents as well as insights into ongoing legal events on those patents.
Voxzogo's Family Patents
Explore Our Curated Drug Screens
Generic Launch
Generic Release Date:
Voxzogo's generic launch date based on the last expiry date of its patents and exclusivities combined is estimated to be Aug 01, 2036 (This date is subject to change depending upon the patent filing activities by the drug owner or exclusivity additions to its drug application)
Voxzogo Generics:
There are no approved generic versions for Voxzogo as of now.
About Voxzogo
Voxzogo is a drug owned by Biomarin Pharmaceutical Inc. It is used for promoting linear growth in pediatric patients with achondroplasia. Voxzogo uses Vosoritide as an active ingredient. Voxzogo was launched by Biomarin Pharm in 2021.
Approval Date:
Voxzogo was approved by FDA for market use on 19 November, 2021.
NCE-1 date:
NCE-1 date also known as the four year date occurs four years after the original drug approval and marks the first opportunity for a generic manufacturer to file an ANDA with a Paragraph IV certification. This is the earliest point when generic competition might begin, provided the challenge is successful. Since the approval date for Voxzogo is 19 November, 2021, its NCE-1 date is estimated to be 19 November, 2025.
Active Ingredient:
Voxzogo uses Vosoritide as the active ingredient. Check out other Drugs and Companies using Vosoritide ingredient
Treatment:
Voxzogo is used for promoting linear growth in pediatric patients with achondroplasia.
Dosage:
Voxzogo is available in powder form for subcutaneous use. Given below is detailed information on Dosage -
| Strength | Dosage Form | Availability | Application Pathway |
|---|---|---|---|
| 1.2MG/VIAL | POWDER | Prescription | SUBCUTANEOUS |
| 0.4MG/VIAL | POWDER | Prescription | SUBCUTANEOUS |
| 0.56MG/VIAL | POWDER | Prescription | SUBCUTANEOUS |