DARZALEX FASPRO Drug Profile

Summary for Tradename: DARZALEX FASPRO

High Confidence Patents:	5
Applicants:	1
BLAs:	1
Recent Clinical Trials:	See clinical trials for DARZALEX FASPRO

Recent Clinical Trials for DARZALEX FASPRO

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Maryland, Baltimore	PHASE1
Johnson & Johnson	PHASE1
Qilu Pharmaceutical Co., Ltd.	PHASE3

See all DARZALEX FASPRO clinical trials

Pharmacology for DARZALEX FASPRO

Mechanism of Action	CD38-directed Antibody Interactions
Established Pharmacologic Class	CD38-directed Cytolytic Antibody Endoglycosidase
Chemical Structure	Antibodies, Monoclonal Glycoside Hydrolases

Note on Biologic Patents

Matching patents to biologic drugs is far more complicated than for small-molecule drugs.

DrugPatentWatch employs three methods to identify biologic patents:

1. Brand-side disclosures in response to biosimilar applications

These patents were identified from disclosures by the brand-side company, in response to a potential biosimilar seeking to launch. They have a high certainty of blocking biosimilar entry. The expiration dates listed are not estimates — they're expiration dates as indicated by the brand-side company.

2. DrugPatentWatch analysis and company disclosures

These patents were identified from searching various sources, including drug labels and other general disclosures from the brand-side company. This list may exclude some of the patents which block biosimilar launch, and some of these patents listed may not actually block biosimilar launch. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

3. Patents from broad patent text search

For completeness, these patents were identified by searching the patent literature for mentions of the branded or ingredient name of the drug. Some of these patents protect the original drug, whereas others may protect follow-on inventions or even inventions casually mentioning the drug. The expiration dates listed for these patents are estimates, based on the grant date of the patent.

1) High Certainty: US Patents for DARZALEX FASPRO Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for DARZALEX FASPRO Derived from DrugPatentWatch Analysis and Company Disclosures

These patents were obtained from company disclosures

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Janssen Biotech, Inc.	DARZALEX FASPRO	daratumumab and hyaluronidase-fihj	Injection	761145		2036-05-20	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	DARZALEX FASPRO	daratumumab and hyaluronidase-fihj	Injection	761145		2040-04-03	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	DARZALEX FASPRO	daratumumab and hyaluronidase-fihj	Injection	761145		2026-03-23	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	DARZALEX FASPRO	daratumumab and hyaluronidase-fihj	Injection	761145		2027-09-26	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	DARZALEX FASPRO	daratumumab and hyaluronidase-fihj	Injection	761145		2030-09-21	DrugPatentWatch analysis and company disclosures

3) Low Certainty: US Patents for DARZALEX FASPRO Derived from Patent Text Search

No patents found based on company disclosures

International Patents for DARZALEX FASPRO

Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	202190387
Taiwan	I838196
South Korea	20070116137
Eurasian Patent Organization	200970317
Slovenia	3827845
Japan	6607825
San Marino	T202200243

Supplementary Protection Certificates for DARZALEX FASPRO

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
301147	Netherlands		PRODUCT NAME: DARATUMUMAB, CYCLOFOSFAMIDE, BORTEZOMIB EN DEXAMETHASON; REGISTRATION NO/DATE: EU/1/16/1101 20210623
LUC00053	Luxembourg		PRODUCT NAME: ANTICORPS DE LIAISON A LA CD38 HUMAINE, COMPRENANT DES SEQUENCES CDR VARIABLES DE CHINE LEGERE HUMAINE ET DE CHIANE LOURDE HUMAINE SELON LA REVENDICATION 1 DU BREVET EP2567976 (SEQ ID NUM 13,14,15,18,19 ET 20) ; PARTICULIEREMENT UN ANTICORPS COMPRENANT LES REGIONS VARIABLES DE CHINE LOURDE ET LEGERE SELON LES REVENDICATIONS 8 ET 10 DU BREVET EP2567976 (SEQ ID NUM 17 ET 12) ; PARTICULIEREMENT UN ANTICORPS COMPRENANT LES REGIONS VARIABLES DE CHAINE LOURDE ET LEGERE SELON LES REVENDICATIONS 8 ET 10 DU BREVET EP2567976 (SEQ ID NUM 17 ET 12), ET QUI EST UN ANTICORPS MONOCLONAL HUMAIN IGG1,K; ET SPECIFIQUEMENT LE DARATUMUMAB.; AUTHORISATION NUMBER AND DATE: EU/1/16/1101 20160524
PA2021014	Lithuania		PRODUCT NAME: DARATUMUMABAS, CIKLOFOSFAMIDAS, BORTEZOMIBAS IR DEKSAMETAZONAS; REGISTRATION NO/DATE: EU/1/16/1101 20210621
CR 2019 00047	Denmark		PRODUCT NAME: DARATUMUMAB, BORTEZOMIB, MELPHALAN OG PREDNISON; REG. NO/DATE: EU/1/16/1101/001-002 20180904
CA 2020 00032	Denmark		PRODUCT NAME: DARATUMUMAB, BORTEZOMIB, THALIDOMID OG DEXAMETHASON; REG. NO/DATE: EU/1/16/1101 20200122
C 2017 054	Romania		PRODUCT NAME: DARATUMUMAB; NATIONAL AUTHORISATION NUMBER: EU/1/16/1101/001-002; DATE OF NATIONAL AUTHORISATION: 20160520; NUMBER OF FIRST AUTHORISATION IN EUROPEAN ECONOMIC AREA (EEA): EU/1/16/1101/001-002; DATE OF FIRST AUTHORISATION IN EEA: 20160520
18C1003	France		PRODUCT NAME: DARATUMUMAB; REGISTRATION NO/DATE: EU/1/16/1101 20160524

Market Dynamics and Financial Trajectory for DARZALEX FASPRO

Last updated: February 20, 2026

DARZALEX FASPRO (daratumumab and hyaluronidase-fihj) is a subcutaneous formulation of Darzalex, the monoclonal antibody used to treat multiple myeloma. It received approval from the FDA in August 2020, offering an alternative to the intravenous form. The drug's market evolution depends on demand, competitive landscape, regulatory factors, and pricing.

Market Position and Adoption

DARZALEX FASPRO benefits from several factors:

• Patient Convenience: Subcutaneous administration reduces infusion time from hours to a few minutes.
• Clinical Efficacy: Comparable or superior outcomes in combination therapies.
• Physician Preference: Ease of use encourages adoption primarily in the U.S. and developed markets.

Market penetration is tied to its approval for multiple indications:

• Newly diagnosed multiple myeloma (NDMM) in combination with other agents.
• Relapsed/refractory multiple myeloma (RRMM).

In 2022, DARZALEX FASPRO's sales surpassed $1.1 billion globally, with rapid growth projected as adoption expands.

Competitive Landscape

Primary competitors include:

• Isatuximab (Sanofi): Approved as a subcutaneous treatment for RRMM.
• Elotuzumab (Eloctar): Used in combination therapies.
• IV formulations of DARZALEX: Still prevalent, but declining as FASPRO gains market share.

Market share has shifted, with FASPRO capturing approximately 40% of daratumumab-related sales by 2022, driven by preference for its injection method.

Pricing and Reimbursement

Pricing impact is a key factor:

• Cost per dose: Approximately $4,500 for FASPRO, comparable to IV formulations but with savings in administration costs.
• Reimbursement policies favor outpatient settings and quick administration, reducing overall treatment costs.

In the U.S., payers increasingly favor subcutaneous formulations, influencing insurance coverage and patient access.

Regulatory and Clinical Development

Key milestones:

• FDA approval: August 2020.
• EMA approval: September 2020.
• Ongoing Phase III studies aim to support expanded indications, promising further revenue streams.

Financial Performance and Projections

Year	Estimated Global Sales (USD billions)	Growth Rate	Comments
2022	1.1	N/A	First full year post-launch
2023	1.35	22.7%	Driven by increased adoption
2024	1.65	22.2%	Broader label approvals; expanded indications

Revenue growth is driven by:

• Expansion in first- and second-line therapy settings.
• Global rollout beyond the U.S.
• Competitive positioning with subcutaneous formulations.

Operating margins benefit from the streamlined administration process, reducing healthcare resource utilization.

Risks and Uncertainties

• Market competition: New agents or biosimilars could erode market share.
• Regulatory challenges: Delays or restrictions could limit expansion.
• Pricing pressures: Payers could push for discounts, impacting revenue.

Key Takeaways

• DARZALEX FASPRO has secured a significant market share in multiple myeloma treatment due to convenience and clinical efficacy.
• Sales are expected to grow at double-digit rates through 2024, supported by label expansion and global adoption.
• Competition from other monoclonal antibodies and biosimilars poses a threat to sustained market dominance.
• Reimbursement dynamics favor subcutaneous formulations, contributing to revenue growth.
• The financial trajectory relies on continued clinical success and market acceptance in emerging regions.

FAQs

1. What factors drive adoption of DARZALEX FASPRO over IV formulations?
Ease of administration, reduced infusion time, and patient preference. Insurance reimbursement favors outpatient and quick-dose treatments.

2. How does DARZALEX FASPRO compare with competitors?
It offers comparable efficacy with the convenience of subcutaneous injection. Competitors include Isatuximab and other monoclonal antibodies, but DARZALEX FASPRO holds a key advantage in ease of use.

3. What is the outlook for future sales growth?
Sales are projected to grow approximately 20-22% annually through 2024, assuming successful expansion and continued clinical approval.

4. What are the main risks to DARZALEX FASPRO’s financial forecast?
Increased competition, biosimilar entry, pricing pressures, and regulatory delays.

5. In what markets is DARZALEX FASPRO seeing the most growth?
Primarily in the U.S. with expanding presence in Europe, Japan, and other high-income countries.

References

[1] U.S. Food and Drug Administration. (2020). FDA approves Darzalex Faspro for multiple myeloma.
[2] Evaluate Pharma. (2023). Market projection data for Daratumumab products.
[3] GlobalData. (2023). Biologic drug sales forecasts for multiple myeloma treatments.