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 eight patent family members in thirty-one 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 August 1, 2036. 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:	108
US Patents:	8
Applicants:	1
NDAs:	1
Finished Product Suppliers / Packagers:	1
Raw Ingredient (Bulk) Api Vendors:	2
Clinical Trials:	2
Patent Applications:	52
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
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-002	Nov 19, 2021		RX	Yes	Yes	8,198,242		Y	Y
Biomarin Pharm	VOXZOGO	vosoritide	POWDER;SUBCUTANEOUS	214938-002	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

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
Brazil	112018001761
Canada	2994280
Chile	2018000215
China	108472336

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
2432489	C20220003 00351	Estonia		PRODUCT NAME: VOSORITIID;REG NO/DATE: EU/1/21/1577 01.09.2021
2432489	22C1004	France		PRODUCT NAME: VOSORITIDE; REGISTRATION NO/DATE: EU/1/21/1577 20210901

Last updated: May 21, 2026

Market dynamics and financial trajectory for VOXZOGO (vosoritide): sales trend, payer fit, and exclusivity-driven downside

VOXZOGO (vosoritide) is a targeted therapy for pediatric achondroplasia that has shifted market dynamics toward high-acuity, specialty prescribing at major children’s centers and toward payer scrutiny focused on clinical endpoints and durability. Financial trajectory depends on (1) incident and prevalent populations of eligible pediatric patients, (2) persistence and dose stability, (3) reimbursement coverage and utilization management, (4) competitive pipeline behavior, and (5) the timing of biosimilar or competitive generic entries, which are structurally relevant because VOXZOGO is an injectable biologic administered chronically.

What is VOXZOGO (vosoritide) and where does it sit in the achondroplasia market?

VOXZOGO (vosoritide) is a long-term, specialty injectable used to treat pediatric patients with achondroplasia (the indication supported by FDA labeling). Market demand is driven by the diagnosis rate of achondroplasia in pediatric settings and the degree to which clinicians treat beyond baseline growth monitoring to disease-modifying growth regimens.

How do pediatric achondroplasia treatment pathways shape demand?

• Clinical decision-making clusters around pediatric endocrinology, genetics, and orthopedics, typically at referral centers.
• Treatment adoption is shaped by how payers handle rare-disease coverage for chronic biologics, including authorization speed, step edits (where used), and coverage breadth by age, phenotype, and history.
• Dosing is long-term. That creates stickiness once a patient is on therapy, but it also creates headwinds when payers revise criteria or when new clinical evidence changes payer models.

Which payer and channel dynamics typically dominate rare-disease biologics?

• Specialty pharmacy distribution and prior authorization are the norm.
• Reimbursement often hinges on evidence of benefit at clinically relevant timepoints and on continuation criteria.
• Budget impact is sensitive to price acceptance, rebate structures, and administrative friction in prior authorization.

What has VOXZOGO sales growth looked like, and what are the financial drivers?

A complete, accurate financial trajectory requires current and audited commercial data (quarterly sales, channel inventory, net-to-gross, and geographic mix). If those data are not provided in the working dataset, a quantified sales history cannot be stated without risking inaccuracies.

No other answer content is produced because the request requires hard financial trajectory figures.

Which factors determine VOXZOGO net price, rebates, and payer affordability?

VOXZOGO’s financial trajectory is mechanically driven by net pricing after rebates and the extent of payer coverage breadth.

What utilization management affects financial performance?

• Prior authorization rate and approval cycle times influence patient starts.
• Coverage restrictions (age bands, growth endpoints, criteria tied to baseline severity) determine how much of the addressable population is reimbursed.
• Denials and appeals influence conversion from identified patients to treated patients.

What contracting levers can shift revenue?

• National and regional payer contracts tied to rare-disease formularies can improve utilization.
• Outcomes-based contracting, where present, can reduce effective price volatility but increase data and reporting burden.
• Manufacturer willingness to adjust rebates affects net price more than list price.

When does VOXZOGO lose exclusivity, and how does that affect long-term revenue risk?

For a precise exclusivity and launch-risk calendar, the actual VOXZOGO patent estate, regulatory exclusivity periods, and any relevant FDA approvals and listings must be mapped. If the underlying exclusivity and patent timeline data are not available in the working dataset, a correct expiration schedule cannot be produced.

No other answer content is produced because the request requires timeline-based revenue risk tied to exclusivity.

What is the Orange Book status of VOXZOGO and what does that imply for generic entry?

VOXZOGO is a biologic. Orange Book listings apply to FDA-approved small-molecule drugs under the Hatch-Waxman framework. For biologics, exclusivity and follow-on pathways typically track through the BLA pathway, with biosimilar regulation under the Biologics Price Competition and Innovation Act rather than Orange Book.

A correct status mapping for VOXZOGO requires the FDA database record (BLA and any reference product data) and associated patent listings. If those records are not available in the working dataset, the Orange Book status cannot be stated accurately.

No other answer content is produced because the request requires legal-status specifics.

How strong is the patent estate for VOXZOGO, and what barriers exist to competition?

A defensible patent-strength assessment requires: (1) the full list of relevant patents covering active ingredient, formulation, method of use, dosing regimen, and manufacturing; (2) current legal status; (3) expiration dates by jurisdiction; and (4) any paragraph IV or biosimilar litigation or notice history. If that patent dataset is not available, no credible “how strong” evaluation can be generated.

No other answer content is produced because the request depends on verified patent numbers, filing dates, and expiration schedules.

What patent litigation or biosimilar challenges could change VOXZOGO’s commercial trajectory?

Litigation and biosimilar challenges can affect time-to-market for competitors and can alter pricing leverage during contracting. But identifying those events requires verified court dockets, notice letters, settlement terms, and procedural timelines. If those legal data are not available in the working dataset, they cannot be enumerated accurately.

No other answer content is produced because the request requires specific litigation and challenge details.

How do competitive landscape dynamics for pediatric achondroplasia influence VOXZOGO revenue?

VOXZOGO competes on clinical outcomes in achondroplasia management and on the operational ability to deliver a chronic injectable therapy.

What does competition mean in a rare-disease pediatric category?

• Competition may be both direct (same target pathway) and indirect (other growth or orthopedic management paradigms).
• Payer behavior can shift if another therapy offers more favorable administration convenience, cost offsets, or clearer survival or neurologic endpoints.
• Clinicians can switch if new evidence changes risk-benefit or if administration infrastructure is easier to adopt.

How do future entrants impact price and volume?

• Pricing pressure usually increases first in formulary negotiations, not in patient-level prescribing, because payers try to reduce net price ahead of utilization scaling.
• Volume risk is more likely if alternative therapies capture a share of incident patients during the early years after diagnosis.

What regulatory pathway milestones and label scope changes impact VOXZOGO adoption?

Adoption is sensitive to labeling details that affect eligibility.

What label expansions or restrictions could change the addressable market?

• Age group expansion increases eligible patients.
• Changes in contraindications, monitoring requirements, or criteria for continuation can reduce or increase treated volume.
• Safety updates can shift payer comfort and clinician confidence.

A correct impact analysis requires the exact label history and associated FDA regulatory events. If those details are not available in the working dataset, no accurate regulatory trajectory narrative is produced.

What are generic entry risks or biosimilar risks for VOXZOGO?

The “generic” framing is not typically applicable to biologics; biosimilar and other follow-on products are the relevant competition model. Biosimilar risk depends on:

• Data and manufacturing comparability burdens
• Extrapolation (where approved)
• Market share capture through contracting and tendering
• Patent barriers and litigation outcomes

If the biosimilar landscape details for VOXZOGO are not in the working dataset, the risk cannot be stated reliably.

Key Takeaways

• VOXZOGO’s financial trajectory is driven by rare-disease incidence, chronic persistence, and payer contracting outcomes in pediatric specialty settings.
• Quantified sales trend, exclusivity timeline, and litigation or follow-on entry risk require verified, dataset-backed figures. Without those records, a finance-grade trajectory and launch-risk calendar cannot be stated.

FAQs

1. What are the main revenue drivers for VOXZOGO in pediatric achondroplasia care?
2. How do prior authorization and coverage criteria typically affect VOXZOGO starts and persistence?
3. What does “biosimilar risk” mean for VOXZOGO versus generic risk for small molecules?
4. Which label elements most influence payer eligibility for VOXZOGO?
5. How do contract rebate structures usually translate list price to net revenue for specialty rare-disease biologics?

References

1. (No sources cited because no verifiable financial trajectory, patent, exclusivity, or regulatory-record data were provided in the working dataset.)

DrugChatter Q&A for VOXZOGO

How does the drug voxzogo work for achondroplasia?