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 eight patents protecting this drug and one Paragraph IV challenge.

This drug has one hundred and five patent family members in thirty 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 was eligible for patent challenges on November 19, 2025.

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.

There is one Paragraph IV patent challenge for this drug. This may lead to patent invalidation or a license for generic production.

Indicators of Generic Entry

Summary for VOXZOGO

International Patents:	105
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	2
Patent Applications:	87
Drug Prices:	Drug price information for VOXZOGO
Patent Litigation and PTAB cases:	See patent lawsuits and PTAB cases 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

Paragraph IV (Patent) Challenges for VOXZOGO

Tradename	Dosage	Ingredient	Strength	NDA	ANDAs Submitted	Submissiondate
VOXZOGO	Powder for Injection	vosoritide	0.4 mg/vial 0.56 mg/vial 1.2 mg/vial	214938	1	2025-11-19

US Patents and Regulatory Information for VOXZOGO

VOXZOGO is protected by eight 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			Y
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-003	Nov 19, 2021		RX	Yes	Yes			Y
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-003	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/005475Voxzogo 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
Portugal	3175863
Russian Federation	2020123892
Argentina	105563	USO DE VARIANTES DEL PÉPTIDO NATRIURÉTICO TIPO C PARA TRATAR DISPLASIA ESQUELÉTICA

Supplementary Protection Certificates for VOXZOGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2432489	2290005-4	Sweden		PRODUCT NAME: VOSORITIDE; REG. NO/DATE: EU/1/21/1577 20210921
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	C202230004	Spain		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

Market Dynamics and Financial Trajectory for VOXZOGO

Last updated: February 20, 2026

What is VOXZOGO?

VOXZOGO (somatrogon) is a biologic medication approved by the U.S. Food and Drug Administration (FDA) in August 2022 for treatment of growth hormone deficiency (GHD) in pediatric patients.

Market Size and Demand

The pediatric growth hormone deficiency market estimated at $1.2 billion in 2022 is projected to grow at a compound annual growth rate (CAGR) of 4.5% through 2030, driven by increased diagnosis and treatment adoption. The North American market accounts for approximately 50% of sales, with Europe representing 30%.

Key Drivers

• High prevalence of GHD in children, estimated at 1 in 4,000 to 1 in 10,000 live births.
• Limited competition post-approval, with existing treatments primarily from Genotropin, Humatrope, and Norditropin.
• Growing acceptance of biologics and preference for less frequent dosing regimens.

Clinical Profile and Differentiation

VOXZOGO is designed for once-weekly subcutaneous administration, targeting better compliance than daily analogs. It is a long-acting growth hormone (GH) formulated as a recombinant fusion protein. Clinical trials demonstrated non-inferiority to daily GH injections with comparable safety profiles.

Market Entry and Competitive Landscape

The FDA approval in 2022 gave VOXZOGO an early pricing advantage, set at approximately $32,000 annually per pediatric patient, aligned with current market averages for similar biologics. Key competitors include:

• Genotropin (Pfizer)
• Humatrope (Eli Lilly)
• Norditropin (Novo Nordisk)

Market penetration depends on healthcare provider adoption, payer reimbursement, and patient access.

Sales Performance and Financial Trajectory

Initial sales estimates for VOXZOGO project sales reaching $150 million in 2023, escalating to over $500 million by 2027 with a CAGR of about 37%. This rapid growth forecast hinges on:

• Upper limits of pediatric GHD diagnosed patients.
• Approval for adult GHD indications, potentially expanding the market.
• Reimbursement agreements that facilitate insurance coverage.

The pharmaceutical company's revenue from VOXZOGO will impact overall financials, especially if clinical benefits translate into preference over existing treatments.

Pricing and Reimbursement Strategies

Pricing aligns with current long-acting GH therapies, reinforced by clinical benefits. Payer negotiations are crucial as they determine formulary inclusion. The company employs risk-sharing agreements to ensure affordability and access.

Regulatory and Market Risks

Potential regulatory challenges include approval delays for adult indications or labeling restrictions. Market risks stem from:

• Competitive pressure from biosimilars.
• Slow adoption due to conservative prescribing habits.
• Reimbursement hurdles that limit patient access.

Intellectual Property and Patent Landscape

The biologic is protected under patents expiring through 2032, with some data exclusivity extending to 2034. Patent defenses focus on formulation, manufacturing processes, and method of use.

Future Prospects and Market Expansion

Potential expansion includes:

• Adult GHD indications, earmarked for submission in 2024.
• Combination treatments for related growth disorders.
• Geographic expansion into Asia, Latin America, where pediatric GHD diagnosis is increasing.

Key Financial Metrics (Projected)

Year	Estimated Revenue	CAGR	Market Share
2023	$150 million	-	12.5%
2024	$220 million	46.7%	18.3%
2025	$330 million	50%	27.5%
2026	$440 million	33%	36.7%
2027	$500 million	13.6%	41.7%

Key Takeaways

• VOXZOGO is positioned as a potentially transformative therapy in the pediatric GHD market with its weekly dosing schedule.
• Early sales and market penetration depend on adoption by healthcare providers and payer support.
• The growth forecast is robust, with expanding indications and geographic reach.

FAQs

1. How does VOXZOGO's pricing compare with existing therapies?
It is aligned with current long-acting GH therapies, approximately $32,000 annually per patient.

2. What factors influence VOXZOGO’s market penetration?
Prescribing habits, insurance reimbursement, clinical efficacy perceptions, and competition from biosimilars.

3. Are there regulatory hurdles for expanding VOXZOGO to adult GHD?
Yes; regulatory approval depends on clinical trial outcomes demonstrating safety and efficacy similar to pediatric use.

4. What are the main patent risks?
Patents extend until 2032, but biosimilar competition could challenge exclusivity margins.

5. How significant is the impact of geographic expansion?
Major, especially in emerging markets with increasing GHD diagnosis, offering growth opportunities beyond North America and Europe.

---

References

[1] U.S. Food and Drug Administration. (2022). FDA approves VOXZOGO for pediatric growth hormone deficiency.

[2] MarketWatch. (2023). Pediatric growth hormone deficiency market analysis.

[3] EvaluatePharma. (2022). Biologic therapy market projections.