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Last Updated: December 23, 2024

VOSORITIDE - Generic Drug Details


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What are the generic sources for vosoritide and what is the scope of patent protection?

Vosoritide is the generic ingredient in one branded drug marketed by Biomarin Pharm and is included in one NDA. There are six patents protecting this compound. Additional information is available in the individual branded drug profile pages.

Vosoritide has eighty-three patent family members in twenty-six countries.

One supplier is listed for this compound.

Summary for VOSORITIDE
International Patents:83
US Patents:6
Tradenames:1
Applicants:1
NDAs:1
Finished Product Suppliers / Packagers: 1
Raw Ingredient (Bulk) Api Vendors: 2
Clinical Trials: 9
Patent Applications: 45
What excipients (inactive ingredients) are in VOSORITIDE?VOSORITIDE excipients list
DailyMed Link:VOSORITIDE at DailyMed
DrugPatentWatch® Estimated Loss of Exclusivity (LOE) Date for VOSORITIDE
Generic Entry Date for VOSORITIDE*:
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.

Recent Clinical Trials for VOSORITIDE

Identify potential brand extensions & 505(b)(2) entrants

SponsorPhase
Roopa Kanakatti ShankarPhase 2
UCSF Benioff Children's Hospital OaklandPhase 1/Phase 2
Andrew DauberPhase 2

See all VOSORITIDE clinical trials

US Patents and Regulatory Information for VOSORITIDE

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 214938-001 Nov 19, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y ⤷  Subscribe
Biomarin Pharm VOXZOGO vosoritide POWDER;SUBCUTANEOUS 214938-002 Nov 19, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Biomarin Pharm VOXZOGO vosoritide POWDER;SUBCUTANEOUS 214938-002 Nov 19, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
Biomarin Pharm VOXZOGO vosoritide POWDER;SUBCUTANEOUS 214938-002 Nov 19, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe Y Y ⤷  Subscribe
Biomarin Pharm VOXZOGO vosoritide POWDER;SUBCUTANEOUS 214938-003 Nov 19, 2021 RX Yes Yes ⤷  Subscribe ⤷  Subscribe ⤷  Subscribe
>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 VOSORITIDE

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 VOSORITIDE

Country Patent Number Title Estimated Expiration
Russian Federation 2728567 ПРИМЕНЕНИЕ ВАРИАНТОВ НАТРИЙУРЕТИЧЕСКОГО ПЕПТИДА С-ТИПА ДЛЯ ЛЕЧЕНИЯ СКЕЛЕТНОЙ ДИСПЛАЗИИ (APPLICATION OF VARIANTS OF NATRIURETIC PEPTIDE OF C-TYPE FOR TREATMENT OF SKELETAL DYSPLASIA) ⤷  Subscribe
Canada 2994280 ⤷  Subscribe
South Korea 20180021233 씨형 나트륨이뇨 펩티드의 변이체 (VARIANTS OF C-TYPE NATRIURETIC PEPTIDE) ⤷  Subscribe
Denmark 3328416 ⤷  Subscribe
Portugal 2432489 ⤷  Subscribe
>Country >Patent Number >Title >Estimated Expiration

Supplementary Protection Certificates for VOSORITIDE

Patent Number Supplementary Protection Certificate SPC Country SPC Expiration SPC Description
2432489 C20220003 00351 Estonia ⤷  Subscribe PRODUCT NAME: VOSORITIID;REG NO/DATE: EU/1/21/1577 01.09.2021
2432489 301162 Netherlands ⤷  Subscribe PRODUCT NAME: VOSORITIDE IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/21/1577 20210901
2432489 CA 2022 00004 Denmark ⤷  Subscribe PRODUCT NAME: VOSORITIDE IN ALL FORMS; REG. NO/DATE: EU/1/21/1577 20210901
2432489 LUC00248 Luxembourg ⤷  Subscribe PRODUCT NAME: VOSORITIDE SOUS TOUTES LES FORMES PROTEGEES PAR LE BREVET DE BASE; AUTHORISATION NUMBER AND DATE: EU/1/21/1577 20210901
2432489 122022000008 Germany ⤷  Subscribe PRODUCT NAME: VOSORITID IN ALLEN DURCH DAS GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/21/1577 20210826
>Patent Number >Supplementary Protection Certificate >SPC Country >SPC Expiration >SPC Description

VOSORITIDE Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for Vosoritide

Introduction to Vosoritide

Vosoritide, marketed under the brand name VOXZOGO, is a groundbreaking treatment for achondroplasia, the most common form of short-limbed dwarfism. Developed by BioMarin Pharmaceutical Inc., vosoritide has revolutionized the treatment landscape for this genetic disorder.

Mechanism of Action

Vosoritide is a C-type natriuretic peptide (CNP) precursor that targets the underlying genetic causes of achondroplasia. It works by binding to the FGFR3 receptor, thereby inhibiting abnormal bone formation associated with the condition. This unique therapeutic strategy makes vosoritide an attractive and effective treatment option for patients and medical professionals[1].

Market Drivers

Several factors are driving the growth of the vosoritide market:

Increasing Demand and Approval

The U.S. FDA approved vosoritide in November 2021 for improving growth in children with achondroplasia, addressing a significant unmet medical need for over 10,000 children in the United States. This approval has significantly boosted the market demand for vosoritide[4].

Clinical Efficacy and Safety

Real-world evidence studies presented at the European Society for Paediatric Endocrinology (ESPE) meeting in 2024 have further supported the safety and efficacy of vosoritide in children with achondroplasia. These positive results have enhanced the credibility and adoption of vosoritide[3].

Government Funding and Healthcare Infrastructure

Government funding for the treatment of rare genetic disorders, along with advancements in healthcare infrastructure, has driven market growth. Increased awareness and favorable health reimbursement policies, particularly in North America, have also contributed to the market's expansion[1][4].

Financial Trajectory

Revenue Growth

BioMarin has reported significant revenue growth driven by vosoritide. In the third quarter of 2024, revenues from VOXZOGO saw a 54% year-over-year increase, contributing substantially to BioMarin's total revenues of $746 million, a 28% increase from the same period in 2023[2].

Market Size and Projections

The global achondroplasia treatment market, led by vosoritide, is expected to grow from USD 172.96 million in 2023 to USD 816.6 million by 2028, at a CAGR of 36.4%. By 2034, the market is projected to reach USD 3.2 billion, with vosoritide expected to remain a major driver of this growth[1][4].

Geographical Performance

North America, particularly the United States, is a dominant market for vosoritide, driven by favorable health reimbursement policies and increased awareness. The Asia-Pacific region is also expected to show lucrative growth due to its large population, rising healthcare spending, and enhanced healthcare infrastructure[1].

Distribution Channels

Hospital Pharmacies

Hospital pharmacies are anticipated to fuel the market growth due to their specialized expertise, immediate medication availability, and participation in research and clinical trials. This segment's strong connections with healthcare providers and patient networks further support the expansion of vosoritide in the market[1].

Online Pharmacies

The COVID-19 pandemic has accelerated the growth of online pharmacies, which offer convenience and ease of access. This trend is expected to continue, contributing to the overall market growth of vosoritide[1].

Route of Administration

The parenteral route of administration for vosoritide is expected to grow at a healthy CAGR. This is due to its effectiveness in drug delivery, patient compliance, and clinical efficacy, making it a preferred method for administering vosoritide[1].

Impact of COVID-19

The COVID-19 pandemic initially disrupted the achondroplasia treatment market but ultimately boosted demand as healthcare professionals adopted telehealth and remote monitoring technologies. This shift ensured continuous treatment planning for patients with achondroplasia, including those on vosoritide[1].

Challenges and Opportunities

Regulatory Hurdles

Despite the positive market dynamics, regulatory hurdles and the need for long-term follow-up studies remain challenges. However, these challenges also present opportunities for further research and development, potentially leading to new treatment options and market expansion[4].

Psychosocial and Emotional Challenges

Patients with achondroplasia face psychosocial and emotional challenges, which vosoritide can help address by improving their quality of life. This aspect underscores the importance of vosoritide beyond its clinical efficacy, highlighting its potential for long-term market growth[4].

Key Takeaways

  • Vosoritide is a groundbreaking treatment for achondroplasia, approved by the FDA in 2021.
  • The drug has shown significant clinical efficacy and safety in real-world evidence studies.
  • Market growth is driven by increasing demand, government funding, and favorable healthcare infrastructure.
  • North America and the Asia-Pacific region are key markets for vosoritide.
  • Hospital pharmacies and online pharmacies are crucial distribution channels.
  • The parenteral route of administration is preferred due to its effectiveness.

FAQs

Q: What is vosoritide, and how does it work? A: Vosoritide is a C-type natriuretic peptide (CNP) precursor that targets the underlying genetic causes of achondroplasia by binding to the FGFR3 receptor, inhibiting abnormal bone formation.

Q: When was vosoritide approved by the FDA? A: Vosoritide was approved by the U.S. FDA in November 2021 for improving growth in children with achondroplasia.

Q: What are the key market drivers for vosoritide? A: Key market drivers include increasing demand, FDA approval, clinical efficacy, government funding, and favorable healthcare infrastructure.

Q: How has the COVID-19 pandemic impacted the vosoritide market? A: The pandemic initially disrupted the market but ultimately boosted demand as healthcare professionals adopted telehealth and remote monitoring technologies.

Q: What are the projected market sizes for the achondroplasia treatment market? A: The market is expected to grow from USD 172.96 million in 2023 to USD 816.6 million by 2028 and reach USD 3.2 billion by 2034.

Cited Sources

  1. Marketdataforecast.com: Achondroplasia Treatment Market Size, Share & Growth, 2032
  2. PR Newswire: BioMarin Announces 28% Y/Y Total Revenue Growth in the Third Quarter and Increase in Full-Year 2024 Guidance
  3. PR Newswire: BioMarin Presents Real-World Evidence Further Supporting Safety and Efficacy of VOXZOGO (vosoritide) in Children with Achondroplasia
  4. GlobeNewswire: Achondroplasia Treatment Market Projected to Reach USD 3.2 Billion by 2034-Unveils Dynamics, Segmentation, and Growth Opportunities[4].

More… ↓

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