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VOXZOGO Drug Patent Profile

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

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

See drug prices for VOXZOGO

DrugPatentWatch^® Estimated Loss of Exclusivity (LOE) Date for VOXZOGO

Constraining patent/regulatory exclusivity:

TO INCREASE LINEAR GROWTH IN PEDIATRIC PATIENTS LESS THAN 5 YEARS OF AGE WITH ACHONDROPLASIA WITH OPEN EPIPHYSES

NDA:

214938

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 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

See all VOXZOGO clinical trials

US Patents and Regulatory Information for VOXZOGO

VOXZOGO is protected by six US patents and four FDA Regulatory Exclusivities.

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.

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
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-003	Nov 19, 2021		RX	Yes	Yes
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-001	Nov 19, 2021		RX	Yes	Yes	11,911,446
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-002	Nov 19, 2021		RX	Yes	Yes
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-003	Nov 19, 2021		RX	Yes	Yes	8,198,242		Y	Y
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-001	Nov 19, 2021		RX	Yes	Yes

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

International Patents for VOXZOGO

See the table below for patents covering VOXZOGO around the world.

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)
Canada	2994280
South Korea	20180021233	씨형 나트륨이뇨 펩티드의 변이체 (VARIANTS OF C-TYPE NATRIURETIC PEPTIDE)
Denmark	3328416
Portugal	2432489
Canada	2758581	VARIANTS DU PEPTIDE NATRIURETIQUE DE TYPE C (VARIANTS OF C-TYPE NATRIURETIC PEPTIDE)

Supplementary Protection Certificates for VOXZOGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2432489	C20220003 00351	Estonia		PRODUCT NAME: VOSORITIID;REG NO/DATE: EU/1/21/1577 01.09.2021
2432489	301162	Netherlands		PRODUCT NAME: VOSORITIDE IN IEDERE VORM ZOALS BESCHERMD DOOR HET BASISOCTROOI; REGISTRATION NO/DATE: EU/1/21/1577 20210901
2432489	CA 2022 00004	Denmark		PRODUCT NAME: VOSORITIDE IN ALL FORMS; REG. NO/DATE: EU/1/21/1577 20210901
2432489	LUC00248	Luxembourg		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		PRODUCT NAME: VOSORITID IN ALLEN DURCH DAS GRUNDPATENT GESCHUETZTEN FORMEN; REGISTRATION NO/DATE: EU/1/21/1577 20210826
2432489	22C1004	France		PRODUCT NAME: VOSORITIDE; REGISTRATION NO/DATE: EU/1/21/1577 20210901

VOXZOGO Market Analysis and Financial Projection Experimental

Market Dynamics and Financial Trajectory for VOXZOGO

Introduction

VOXZOGO, developed by BioMarin Pharmaceutical Inc., has emerged as a significant growth driver for the company, particularly in the treatment of achondroplasia, a form of dwarfism. Here, we delve into the market dynamics and financial trajectory of this drug, highlighting its impact on BioMarin's performance and the challenges it faces.

FDA Approval and Market Launch

VOXZOGO received FDA approval in late 2021 for the treatment of achondroplasia, marking a crucial milestone for BioMarin. The drug's launch has been highly successful, exceeding initial sales forecasts and becoming a key growth driver for the company[1][3][5].

Sales Performance

The sales figures for VOXZOGO have been impressive. In the second quarter of 2023, sales jumped 229% to $113.3 million, and by the third quarter of 2024, sales had reached $190 million, representing a 54% year-over-year increase. This growth has contributed significantly to BioMarin's overall revenue, with VOXZOGO driving a substantial portion of the company's financial performance[1][2][4].

Supply Chain Challenges

Despite the strong sales, BioMarin has faced supply chain bottlenecks, particularly in fill-finish capacity. This has constrained the growth rate of VOXZOGO, as the company relies on third-party contractors for the final steps of drug production. BioMarin's CEO, Jean-Jacques Bienaimé, expects these supply issues to ease by 2025, but they remain a significant challenge in the short term[1].

Financial Impact

The success of VOXZOGO has had a profound impact on BioMarin's financials. For the full year 2023, BioMarin raised its VOXZOGO sales forecast to the $400 million to $440 million range, despite the supply constraints. In 2024, the company reported record revenues of $746 million in the third quarter, with VOXZOGO sales being a major contributor to this growth. The company has also updated its 2024 revenue guidance to $2.79 billion to $2.825 billion, reflecting the drug's continued strong performance[2][3][5].

Market Expansion and Patient Uptake

VOXZOGO's global market expansion has been rapid, with over 3,800 patients now on the drug, up from around 3,500 in the second quarter of 2024. This increased patient uptake across all regions has been a key factor in the drug's success. BioMarin is also planning to expand VOXZOGO's market reach further, targeting 11 high-impact launches by 2034[2][4].

Competitive Landscape

While VOXZOGO has dominated the market for achondroplasia treatment, it faces potential competition from other drugs. Ascendis Pharma's investigational drug TransCon CNP (navepegritide) has shown promising results and is expected to be filed for regulatory approval in the first quarter of 2025. This could pose a threat to VOXZOGO's market share and revenue growth in the mid to long term[4].

Strategic Initiatives and Portfolio Review

BioMarin is undergoing a strategic portfolio review to optimize its assets and focus on high-value products. The company is restructuring into new business units for skeletal conditions, enzyme therapies, and ROCTAVIAN, its gene therapy for hemophilia A. This restructuring aims to improve efficiency and maximize the potential of VOXZOGO and other key products[2][3].

Financial Guidance and Outlook

For 2024, BioMarin forecasts robust revenue growth driven by VOXZOGO and its enzyme therapies. The company expects a non-GAAP operating margin of 23-24% and non-GAAP diluted EPS of $3.25-$3.35. Despite the supply issues and potential competitive threats, BioMarin remains optimistic about VOXZOGO's future, anticipating that the supply plan will support revenues that will "easily beat the current consensus for VOXZOGO in '24"[2][3].

Key Metrics and Performance Indicators

• Revenue Growth: VOXZOGO sales have driven significant revenue growth for BioMarin, with a 178% year-over-year increase in Q4 2023 and a 54% increase in Q3 2024[2][3].
• Patient Uptake: Over 3,800 patients are now on VOXZOGO, reflecting rapid global market expansion[4].
• Supply Chain: Despite supply bottlenecks, BioMarin expects these issues to be resolved by 2025[1].
• Competitive Threats: Potential competition from Ascendis Pharma's TransCon CNP could impact VOXZOGO's market share and revenue growth[4].

Quotes from Industry Experts

• Jean-Jacques Bienaimé, BioMarin CEO: "Voxzogo is doing way, way better than anybody, including ourselves, anticipated in terms of penetration."[1]
• Greg Guyer, Ph.D., Chief Technical Officer, Manufacturing and Technical Operations at BioMarin: "Supply remains tight from an inventory perspective... My team is doing everything we can to continue to escalate or accelerate supply from the CMO."[1]

Illustrative Statistics

• Sales Growth: 229% increase in VOXZOGO sales in Q2 2023 to $113.3 million[1].
• Revenue Contribution: VOXZOGO contributed $190 million in Q3 2024, a 54% year-over-year increase[2].
• Patient Growth: Close to 300 new patients added in Q4 2023, bringing the total to over 3,800 patients on VOXZOGO[3][4].

Conclusion

VOXZOGO has been a game-changer for BioMarin, driving significant revenue growth and expanding the company's market presence. Despite the challenges posed by supply chain bottlenecks and potential competition, the drug's strong performance and the company's strategic initiatives position BioMarin for continued success.

Key Takeaways

• Strong Sales Performance: VOXZOGO has exceeded sales forecasts, contributing substantially to BioMarin's revenue growth.
• Supply Chain Issues: Fill-finish capacity constraints have limited the drug's growth potential, but these issues are expected to be resolved by 2025.
• Market Expansion: Rapid global market expansion and increased patient uptake have been key factors in VOXZOGO's success.
• Competitive Landscape: Potential competition from Ascendis Pharma's TransCon CNP could impact VOXZOGO's market share.
• Strategic Initiatives: BioMarin is restructuring and focusing on high-value products to maximize VOXZOGO's potential.

FAQs

Q: What is VOXZOGO used for? A: VOXZOGO is used for the treatment of achondroplasia, a form of dwarfism.

Q: How has VOXZOGO performed in terms of sales? A: VOXZOGO has seen significant sales growth, with a 229% increase in Q2 2023 and a 54% year-over-year increase in Q3 2024.

Q: What are the main challenges facing VOXZOGO's growth? A: The main challenges include supply chain bottlenecks, particularly in fill-finish capacity, and potential competition from other drugs.

Q: How is BioMarin addressing the supply chain issues? A: BioMarin is working to accelerate supply from third-party contractors and expects these issues to be resolved by 2025.

Q: What is the outlook for VOXZOGO in the future? A: Despite current challenges, BioMarin remains optimistic about VOXZOGO's future, anticipating continued revenue growth and market expansion.

Sources

1. FiercePharma: BioMarin's barnstorming Voxzogo launch creates supply bottleneck[1].
2. Investing.com: Earnings call: BioMarin reports robust Q3 growth with VOXZOGO sales surge[2].
3. Investing.com: Earnings call: BioMarin reports robust growth with VOXZOGO driving sales[3].
4. BioSpace: BioMarin Surpasses Analysts' Q3 Sales Estimates Despite VOXZOGO's Slight Miss[4].
5. BioMarin: BioMarin Announces Strong Second Quarter 2023 Results and Record-Breaking Revenues[5].