VOXZOGO Drug Patent Profile

« Back to Dashboard

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.

The generic ingredient in VOXZOGO is vosoritide. There is one drug master file entry for this compound. 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 August 1, 2036. This may change due to patent challenges or generic licensing.

There has been one patent litigation case involving the patents protecting this drug, indicating strong interest in generic launch. Recent data indicate that 63% of patent challenges are decided in favor of the generic patent challenger and that 54% of successful patent challengers promptly launch generic drugs.

Indicators of Generic Entry

Summary for VOXZOGO

US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	2
Patent Applications:	56
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:

9,907,834

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 patent 9,907,834.

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	9,907,834		Y
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-003	Nov 19, 2021		RX	Yes	Yes	12,514,906		Y
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	RE48267
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-001	Nov 19, 2021		RX	Yes	Yes	11,911,446

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

When does loss-of-exclusivity occur for VOXZOGO?

Based on analysis by DrugPatentWatch, the following patents block generic entry in the countries listed below:

Argentina

Australia

Brazil

Canada

Chile

China

Colombia

European Patent Office

Hong Kong

Israel

Japan

Mexico

Russian Federation

South Korea

Taiwan

Generics may enter earlier, or later, based on new patent filings, patent extensions, patent invalidation, early generic licensing, generic entry preferences, and other factors.

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

Country	Patent Number	Title	Estimated Expiration
Argentina	105563
Australia	2016298425
Australia	2023200669
Australia	2026203845
Brazil	112018001761

Supplementary Protection Certificates for VOXZOGO

Patent Number	Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
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	301162	Netherlands		PRODUCT NAME: VOSORITIDE; 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	2022C/503	Belgium		PRODUCT NAME: VOSORITIDE SOUS TOUTES SES 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

VOXZOGO Market Dynamics, Revenue Growth, Patent Risk, and Commercial Outlook

Last updated: October 26, 2026

VOXZOGO, BioMarin Pharmaceutical’s vosoritide injection, is the first approved pharmacologic treatment designed to increase linear growth in children with achondroplasia. Revenue rose from approximately $110 million in 2022 to $473 million in 2023 and about $779 million in 2024, making VOXZOGO one of BioMarin’s fastest-growing products.[1][2] Growth is being driven by international launches, expansion into younger children, increasing diagnosis and treatment adoption, and the absence of an approved competing drug.

The commercial opportunity remains substantial, but the product has structural limits: it is administered by daily subcutaneous injection, only treats children with open growth plates, requires long-term adherence, and addresses a relatively small rare-disease population. Near-term generic and biosimilar erosion appears limited, while clinical competition from long-acting C-type natriuretic peptide programs is the more important strategic risk.

What is VOXZOGO and how does it work?

VOXZOGO contains vosoritide, a modified analog of C-type natriuretic peptide, or CNP. It activates natriuretic peptide receptor-B and counteracts signaling through the FGFR3 pathway, which is overactive in achondroplasia and suppresses endochondral bone growth.[3]

The product is administered once daily by subcutaneous injection. Dosing is weight-based and requires dose adjustment as the child grows. Treatment is intended for children with achondroplasia whose growth plates remain open.

What did the FDA approve?

The FDA approved VOXZOGO in November 2021 for children five years of age and older with achondroplasia and open epiphyses.[4] In 2023, the FDA expanded the indication to children two years of age and older.[5]

The pivotal Phase 3 study enrolled children aged five to 14 years. At 52 weeks, vosoritide produced an adjusted annualized growth velocity approximately 1.57 centimeters per year greater than placebo.[4] The treatment does not reverse the genetic cause of achondroplasia and is not intended for patients with closed growth plates.

Product attribute	VOXZOGO
Active ingredient	Vosoritide
Sponsor	BioMarin Pharmaceutical
FDA approval	November 2021
FDA pediatric expansion	2023, age two and older
Route	Daily subcutaneous injection
Eligible population	Children with achondroplasia and open growth plates
Regulatory category	New drug application, NDA 214938
Primary benefit	Increased annualized growth velocity
Main treatment limitation	Benefit depends on remaining growth potential

How large is the VOXZOGO market?

The addressable market is defined by achondroplasia prevalence, diagnosis rates, age distribution, open growth plates, geographic access, and willingness to use daily injectable therapy.

Achondroplasia occurs in roughly one of every 15,000 to 30,000 births. The global prevalent population is commonly estimated in the hundreds of thousands, but the commercial treatment pool is materially smaller because VOXZOGO is primarily used in children before epiphyseal closure.[3]

BioMarin has expanded access through approvals in the United States, European Union, Japan and other markets. Europe is strategically important because the product received an early authorization for children aged two years and older, subject to local reimbursement decisions.[6]

What is the eligible pediatric population?

The eligible population has four filters:

1. Confirmed achondroplasia.
2. Age within the approved range.
3. Open growth plates.
4. Access to diagnosis, specialist care, reimbursement and treatment monitoring.

The population expands as younger children become eligible, but the age expansion also increases the duration of therapy per patient. That supports revenue per treated patient while increasing adherence and safety-monitoring requirements.

How fast is VOXZOGO revenue growing?

VOXZOGO revenue has moved from launch-stage sales to a material BioMarin franchise.

Fiscal year	Reported VOXZOGO revenue	Approximate year-over-year growth
2022	$110 million	Launch-year base
2023	$473 million	Approximately 330%
2024	$779 million	Approximately 65%

Source: BioMarin annual reports and earnings disclosures.[1][2]

The 2022 figure reflects the limited period after the U.S. launch and early market access. The 2023 increase reflected broader reimbursement, international commercialization and higher diagnosis and prescribing rates. In 2024, growth remained strong but began to normalize as the revenue base expanded.

What is driving the financial trajectory?

The main growth drivers are:

• Expansion from children aged five and older into the two-to-four age group.
• Higher penetration among diagnosed children.
• More countries obtaining reimbursement or commercial access.
• Greater physician familiarity with achondroplasia-directed therapy.
• Longer treatment duration for patients who start at younger ages.
• Continued absence of an approved competitor with the same mechanism.

BioMarin has also benefited from the product’s orphan-drug economics. A rare-disease therapy can generate significant revenue without broad primary-care penetration if pricing, persistence and international access are favorable.

What are the main commercial constraints on VOXZOGO?

The product’s market potential is constrained by treatment logistics and clinical eligibility.

Daily injections affect persistence

VOXZOGO requires daily subcutaneous administration over several years. This can create adherence problems, injection fatigue and caregiver burden. Younger patients may require caregivers to administer every dose.

Treatment stops when growth plates close

The product has a finite treatment window. Patients cannot continue to generate growth benefit after epiphyseal closure, which creates an automatic ceiling on lifetime duration.

Clinical benefit is meaningful but incremental

The pivotal study demonstrated increased growth velocity rather than a complete normalization of stature or elimination of skeletal complications. Physicians and families weigh that benefit against daily injections, monitoring, cost and the natural variability of achondroplasia outcomes.

Reimbursement remains decisive

Rare-disease reimbursement can vary across commercial insurers, Medicaid programs and national health systems. Prior authorization may require genetic confirmation, radiographic evidence of open growth plates, age documentation and specialist prescribing.

What patents protect VOXZOGO?

VOXZOGO is protected by a combination of composition, peptide-modification, formulation, manufacturing and method-of-use rights. The commercial protection strategy is broader than a single active-ingredient patent because vosoritide is a modified peptide and its development depends on defined sequence, structural and production characteristics.

The relevant patent categories include:

Protection category	Commercial purpose
Modified CNP or vosoritide composition	Protects the active peptide and structural variants
Peptide sequence and conjugation claims	Protects stabilizing modifications and activity
Pharmaceutical formulations	Protects injectable compositions and excipient systems
Manufacturing processes	Protects peptide production, purification and consistency
Method-of-use claims	Protects treatment of achondroplasia and growth disorders
Pediatric treatment regimens	May cover age, dose or growth-related treatment parameters

BioMarin’s filings indicate patent protection extending into the 2030s, subject to patent-specific expiration, patent-term adjustment, terminal disclaimers, and any available patent-term extension.[1] The operative protection must be evaluated patent by patent in the FDA Orange Book, USPTO records and relevant national registers.

What is the Orange Book status of VOXZOGO?

VOXZOGO is approved under an NDA and has Orange Book-listed patent protection associated with the product. The commercial impact of those listings depends on:

• The number of listed patents.
• Whether claims cover the drug substance, formulation or method of use.
• Patent expiration dates.
• Whether pediatric exclusivity applies.
• The scope of any Paragraph IV certification.
• Whether BioMarin obtains injunctive relief or settles a challenge.

Because VOXZOGO is a synthetic peptide rather than a conventional small molecule, a future entrant could face more complex analytical, formulation and manufacturing requirements than a standard tablet generic. The product’s regulatory pathway may also depend on whether the proposed product qualifies for an abbreviated pathway based on the applicable FDA framework.

When does VOXZOGO lose exclusivity?

VOXZOGO does not have one single exclusivity-loss date. Regulatory exclusivity and patent exclusivity operate separately.

Exclusivity layer	Relevance to VOXZOGO
Orphan-drug exclusivity	FDA orphan exclusivity generally provides seven years from approval for the protected indication
Pediatric exclusivity	May add six months to qualifying regulatory exclusivity or listed patent terms
Composition patents	Usually the strongest barrier to early product substitution
Formulation patents	Can delay or complicate alternative injectable products
Method-of-use patents	May be challenged through carve-outs or labeling strategies
Manufacturing patents	Can raise technical barriers but may not block all alternative processes

The seven-year U.S. orphan exclusivity period from the November 2021 approval would ordinarily run into late 2028 for the approved indication, before accounting for any applicable pediatric extension.[4] Patent protection may extend beyond that period and is likely to be the more important barrier to competition in the 2030s.

Are there Paragraph IV challenges or VOXZOGO patent lawsuits?

No material VOXZOGO Paragraph IV challenge or U.S. patent settlement had been publicly identified in BioMarin’s reported disclosures through 2024.[1][2] BioMarin’s public filings did not identify a major litigation event that had materially impaired VOXZOGO commercialization during that period.

A future Paragraph IV filing would trigger a potential 30-month stay if the statutory conditions were met and could create several outcomes:

1. Litigation lasting through the challenged patent term.
2. A settlement with a negotiated launch date.
3. A finding that the patent is invalid or not infringed.
4. A launch after the challenger defeats or avoids the listed patents.
5. A carve-out strategy for method-of-use claims.

The absence of a disclosed challenge reduces immediate generic-entry risk but does not eliminate later litigation risk.

What generic, biosimilar and competitive risks exist?

Biosimilar risk is limited in the near term

VOXZOGO is not a conventional monoclonal antibody or other large biologic. It is a modified peptide administered by injection. The principal competitive issue is therefore likely to involve peptide or follow-on drug regulation rather than a traditional interchangeable biosimilar market.

A competitor would still need to demonstrate identity or sufficient comparability, manufacturing consistency, stability, delivery-device compatibility and clinical or pharmacologic performance under the applicable FDA pathway.

Clinical competition is more important than near-term generic substitution

Potential competition includes:

• Long-acting CNP analogs intended to reduce injection frequency.
• Other growth-modifying therapies targeting the FGFR3 pathway.
• Investigational agents designed to improve skeletal growth.
• Surgical limb-lengthening procedures.
• Off-label growth hormone use in selected settings.

Long-acting delivery could be commercially disruptive because injection frequency is one of VOXZOGO’s clearest disadvantages. A competing product would need to match or exceed growth outcomes while demonstrating acceptable cardiovascular, skeletal and developmental safety.

How strong is the VOXZOGO patent estate?

The estate appears commercially strong through the remainder of the 2020s and potentially into the 2030s because protection is supported by multiple technical layers rather than a single use patent. The strongest assets are likely those covering the modified peptide itself and core pharmaceutical composition.

The main vulnerabilities are:

• Potential invalidity challenges against broad composition claims.
• Design-around opportunities involving alternative CNP analogs.
• Regulatory separation between patent claims and the approved label.
• Difficulty enforcing method-of-use patents against off-label prescribing.
• The possibility that a follow-on product uses a different sequence or formulation.

Manufacturing and analytical know-how add practical protection. Those barriers are valuable in peptide products but generally do not create the same legal exclusivity as a valid composition patent.

Which companies are challenging VOXZOGO?

No approved direct pharmacologic competitor had displaced VOXZOGO in achondroplasia treatment through 2024. Competitive activity is concentrated in development-stage programs rather than marketed products.

BioMarin’s commercial advantage remains strongest while it has:

• The only approved drug specifically indicated to increase growth in achondroplasia.
• First-mover physician and specialist relationships.
• Established reimbursement infrastructure.
• Longitudinal pediatric safety and growth data.
• Experience managing treatment through childhood.

The competitive position would weaken if a rival produced similar growth gains with monthly, quarterly or otherwise less frequent administration.

What is the outlook for VOXZOGO revenue?

The base commercial outlook remains positive, with revenue supported by penetration growth and the younger-age indication. Growth should decelerate from the launch-period rate as the treated population matures and more eligible patients enter therapy.

Upside factors

• Faster diagnosis of achondroplasia.
• Higher reimbursement approval rates.
• Expanded treatment in children aged two to four.
• Improved persistence and patient-support services.
• Additional international approvals.
• Label expansion into related skeletal dysplasias, if clinically and regulatorily successful.

Downside factors

• Slower payer adoption.
• Treatment discontinuation or poor adherence.
• Safety findings affecting long-term use.
• A long-acting competitor.
• Patent invalidation or a successful Paragraph IV challenge.
• Pricing pressure in Europe and other single-payer markets.
• Limited benefit perceived by families or physicians.

VOXZOGO is likely to remain a major BioMarin growth asset, but the long-term valuation depends on the duration of treatment, geographic reimbursement and the timing of a lower-frequency competitor more than on broad population expansion.

Key Takeaways

• VOXZOGO is BioMarin’s vosoritide product for children with achondroplasia and open growth plates.
• FDA approval began in November 2021 for children aged five and older; the indication expanded to age two and older in 2023.
• Revenue increased from approximately $110 million in 2022 to $473 million in 2023 and $779 million in 2024.
• Market growth is driven by pediatric expansion, international access and increasing treatment penetration.
• Daily injection, finite treatment duration and reimbursement requirements constrain adoption.
• Patent protection is expected to extend beyond the initial U.S. orphan-exclusivity period and into the 2030s, depending on individual patent terms.
• No material Paragraph IV challenge or major VOXZOGO patent settlement was publicly disclosed through 2024.
• Near-term biosimilar risk is limited; long-acting CNP competitors present the more important strategic threat.
• Revenue should continue growing, but percentage growth will likely moderate as the treated population matures.

FAQs About VOXZOGO Market and Patent Risk

What is the annual cost of VOXZOGO treatment?

The economic cost varies by patient weight, dosing, payer discounts, country and duration of therapy. U.S. gross pricing does not equal net realized revenue because BioMarin uses payer contracts, rebates and patient-support programs.

Is VOXZOGO a biologic or a generic drug?

VOXZOGO is a modified synthetic peptide approved through an NDA. It is not a conventional monoclonal-antibody biologic, and future competition may follow a peptide or drug-specific abbreviated pathway rather than a standard small-molecule generic or traditional biosimilar pathway.

Can adults with achondroplasia use VOXZOGO?

The approved pediatric indication requires open growth plates. Adults generally have closed growth plates and fall outside the product’s approved growth-treatment population.

Does VOXZOGO cure achondroplasia?

No. VOXZOGO modifies growth signaling and increases growth velocity in eligible children. It does not remove the underlying FGFR3 mutation or eliminate all skeletal, neurologic or respiratory complications associated with achondroplasia.

What would most damage VOXZOGO sales?

The greatest commercial risks are a long-acting competing CNP product, weaker-than-expected treatment persistence, restrictive reimbursement, or a successful patent challenge that enables an earlier competing launch.

References

1. BioMarin Pharmaceutical Inc. (2025). 2024 annual report on Form 10-K. U.S. Securities and Exchange Commission.
2. BioMarin Pharmaceutical Inc. (2024). 2023 annual report on Form 10-K. U.S. Securities and Exchange Commission.
3. Savarirayan, R., Tofts, L., Irving, M., Wilcox, W. R., Bacino, C. A., Hoover-Fong, J., et al. (2021). C-Type natriuretic peptide analogue therapy in children with achondroplasia. New England Journal of Medicine, 384(13), 1203-1215.
4. U.S. Food and Drug Administration. (2021). FDA approves first drug for children with achondroplasia, a rare disorder of bone growth.
5. U.S. Food and Drug Administration. (2023). VOXZOGO prescribing information.
6. European Medicines Agency. (2021). VOXZOGO: EPAR - product information.