VOXZOGO Drug Patent Profile
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When do Voxzogo patents expire, and what generic alternatives are available?
Voxzogo is a drug marketed by Biomarin Pharm and is included in one NDA. There are six patents protecting this drug.
This drug has eighty-three patent family members in twenty-six countries.
The generic ingredient in VOXZOGO is vosoritide. One supplier is listed for this compound. Additional details are available on the vosoritide profile page.
DrugPatentWatch® Generic Entry Outlook for Voxzogo
Voxzogo will be eligible for patent challenges on November 19, 2025. This date may extended up to six months if a pediatric exclusivity extension is applied to the drug's patents.
By analyzing the patents and regulatory protections it appears that the earliest date
for generic entry will be October 20, 2030. This may change due to patent challenges or generic licensing.
Indicators of Generic Entry
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Summary for VOXZOGO
| International Patents: | 83 |
| US Patents: | 6 |
| Applicants: | 1 |
| NDAs: | 1 |
| Finished Product Suppliers / Packagers: | 1 |
| Raw Ingredient (Bulk) Api Vendors: | 2 |
| Clinical Trials: | 2 |
| Patent Applications: | 11 |
| Drug Prices: | Drug price information for VOXZOGO |
| DailyMed Link: | VOXZOGO at DailyMed |
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VOXZOGO
*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.
Recent Clinical Trials for VOXZOGO
Identify potential brand extensions & 505(b)(2) entrants
| Sponsor | Phase |
|---|---|
| Roopa Kanakatti Shankar | Phase 2 |
| UCSF Benioff Children's Hospital Oakland | Phase 1/Phase 2 |
US Patents and Regulatory Information for VOXZOGO
VOXZOGO is protected by six US patents and four FDA Regulatory Exclusivities.
Based on analysis by DrugPatentWatch, the earliest date for a generic version of VOXZOGO is ⤷ Sign Up.
This potential generic entry date is based on TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS LESS THAN 5 YEARS OF AGE WITH ACHONDROPLASIA WITH OPEN EPIPHYSES.
Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.
Patents protecting VOXZOGO
Use of C-type natriuretic peptide variants to treat skeletal dysplasia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES
Variants of C-type natriuretic peptide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES
Use of C-type natriuretic peptide variants to treat skeletal dysplasia
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Variants of C-type natriuretic peptide
Patent Number: ⤷ Sign Up
Patent Expiration: ⤷ Sign Up
Patented Use: USE TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WITH OPEN EPIPHYSES
FDA Regulatory Exclusivity protecting VOXZOGO
NEW CHEMICAL ENTITY
Exclusivity Expiration: ⤷ Sign Up
TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS LESS THAN 5 YEARS OF AGE WITH ACHONDROPLASIA WITH OPEN EPIPHYSES
Exclusivity Expiration: ⤷ Sign Up
NEW PATIENT POPULATION
Exclusivity Expiration: ⤷ Sign Up
TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS WITH ACHONDROPLASIA WHO ARE 5 YEARS OF AGE AND OLDER WITH OPEN EPIPHYSES
Exclusivity Expiration: ⤷ Sign Up
| Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | TE | Type | RLD | RS | Patent No. | Patent Expiration | Product | Substance | Delist Req. | Exclusivity Expiration |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Biomarin Pharm | VOXZOGO | vosoritide | POWDER;SUBCUTANEOUS | 214938-003 | Nov 19, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Biomarin Pharm | VOXZOGO | vosoritide | POWDER;SUBCUTANEOUS | 214938-003 | Nov 19, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Biomarin Pharm | VOXZOGO | vosoritide | POWDER;SUBCUTANEOUS | 214938-001 | Nov 19, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Biomarin Pharm | VOXZOGO | vosoritide | POWDER;SUBCUTANEOUS | 214938-002 | Nov 19, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | ⤷ Sign Up | ||||
| Biomarin Pharm | VOXZOGO | vosoritide | POWDER;SUBCUTANEOUS | 214938-003 | Nov 19, 2021 | RX | Yes | Yes | ⤷ Sign Up | ⤷ Sign Up | Y | Y | ⤷ Sign Up | ||
| >Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >TE | >Type | >RLD | >RS | >Patent No. | >Patent Expiration | >Product | >Substance | >Delist Req. | >Exclusivity Expiration |
EU/EMA Drug Approvals for VOXZOGO
| Company | Drugname | Inn | Product Number / Indication | Status | Generic | Biosimilar | Orphan | Marketing Authorisation | Marketing Refusal |
|---|---|---|---|---|---|---|---|---|---|
| BioMarin International Limited | Voxzogo | vosoritide | EMEA/H/C/005475 Voxzogo is indicated for the treatment of achondroplasia in patients 4 months of age and older whose epiphyses are not closed. The diagnosis of achondroplasia should be confirmed by appropriate genetic testing. |
Authorised | no | no | yes | 2021-08-26 | |
| >Company | >Drugname | >Inn | >Product Number / Indication | >Status | >Generic | >Biosimilar | >Orphan | >Marketing Authorisation | >Marketing Refusal |
International Patents for VOXZOGO
See the table below for patents covering VOXZOGO around the world.
| Country | Patent Number | Title | Estimated Expiration |
|---|---|---|---|
| Russian Federation | 2020123892 | ПРИМЕНЕНИЕ ВАРИАНТОВ НАТРИЙУРЕТИЧЕСКОГО ПЕПТИДА C-ТИПА ДЛЯ ЛЕЧЕНИЯ СКЕЛЕТНОЙ ДИСПЛАЗИИ | ⤷ Sign Up |
| Taiwan | 202322847 | Use of C-type natriuretic peptide variants to treat skeletal dysplasia | ⤷ Sign Up |
| Spain | 2904360 | ⤷ Sign Up | |
| China | 114796460 | ⤷ Sign Up | |
| Taiwan | 202432171 | ⤷ Sign Up | |
| >Country | >Patent Number | >Title | >Estimated Expiration |
Supplementary Protection Certificates for VOXZOGO
| Patent Number | Supplementary Protection Certificate | SPC Country | SPC Expiration | SPC Description |
|---|---|---|---|---|
| 2432489 | 2022C/503 | Belgium | ⤷ Sign Up | PRODUCT NAME: VOSORITIDE SOUS TOUTES SES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/21/1577 20210901 |
| 2432489 | C202230004 | Spain | ⤷ Sign Up | PRODUCT NAME: VOSORITIDE; NATIONAL AUTHORISATION NUMBER: EU/1/21/1577; DATE OF AUTHORISATION: 20210826; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/21/1577; DATE OF FIRST AUTHORISATION IN EEA: 20210826 |
| 2432489 | C20220003 00351 | Estonia | ⤷ Sign Up | PRODUCT NAME: VOSORITIID;REG NO/DATE: EU/1/21/1577 01.09.2021 |
| 2432489 | 301162 | Netherlands | ⤷ Sign Up | PRODUCT NAME: VOSORITIDE IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/21/1577 20210901 |
| 2432489 | CA 2022 00004 | Denmark | ⤷ Sign Up | PRODUCT NAME: VOSORITIDE IN ALL FORMS; REG. NO/DATE: EU/1/21/1577 20210901 |
| >Patent Number | >Supplementary Protection Certificate | >SPC Country | >SPC Expiration | >SPC Description |
Make Better Decisions: Try a trial or see plans & pricing
Drugs may be covered by multiple patents or regulatory protections. All trademarks and applicant names are the property of their respective owners or licensors. Although great care is taken in the proper and correct provision of this service, thinkBiotech LLC does not accept any responsibility for possible consequences of errors or omissions in the provided data. The data presented herein is for information purposes only. There is no warranty that the data contained herein is error free. thinkBiotech performs no independent verification of facts as provided by public sources nor are attempts made to provide legal or investing advice. Any reliance on data provided herein is done solely at the discretion of the user. Users of this service are advised to seek professional advice and independent confirmation before considering acting on any of the provided information. thinkBiotech LLC reserves the right to amend, extend or withdraw any part or all of the offered service without notice.
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