DARZALEX Drug Profile

Summary for Tradename: DARZALEX

High Confidence Patents:	5
Applicants:	1
BLAs:	2
Recent Clinical Trials:	See clinical trials for DARZALEX

Recent Clinical Trials for DARZALEX

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
University of Maryland, Baltimore	PHASE1
Johnson & Johnson	PHASE1
Shanghai Henlius Biotech	PHASE3

See all DARZALEX clinical trials

Pharmacology for DARZALEX

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

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 Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for DARZALEX 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	daratumumab	Injection	761036	7,829,673	2026-03-23	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036	9,040,050	2027-09-26	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036	9,187,565	2030-09-21	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	DARZALEX FASPRO	daratumumab and hyaluronidase-fihj	Injection	761145	10,766,965	2036-05-20	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	DARZALEX FASPRO	daratumumab and hyaluronidase-fihj	Injection	761145	11,566,079	2040-04-03	DrugPatentWatch analysis and company disclosures

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

These patents were obtained by searching patent claims

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Patent No.	Estimated Patent Expiration	Source
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036	10,047,163	2034-02-07	Patent claims search
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036	10,100,034	2037-07-25	Patent claims search
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036	10,106,620	2035-06-15	Patent claims search
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036	10,213,513	2035-06-12	Patent claims search
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036	10,220,072	2037-12-06	Patent claims search

International Patents for DARZALEX

Country	Patent Number	Estimated Expiration
Mexico	2021014956
Israel	255740
Ecuador	SP18040758
Japan	2012070737
Chile	2018001202

Supplementary Protection Certificates for DARZALEX

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
301008	Netherlands		PRODUCT NAME: DARATUMUMAB, LENALIDOMIDE EN DEXAMETHASON; REGISTRATION NO/DATE: EU/1/16/1101 20170503
122025000016	Germany		PRODUCT NAME: DARATUMUMAB, BORTEZOMIB, LENALIDOMID UND DEXAMETHASON; REGISTRATION NO/DATE: EU/1/16/1101 20241021
2021C/555	Belgium		PRODUCT NAME: DARATUMUMAB, CYCLOFOSFAMIDE, BORTEZOMIB EN DEXAMETHASON; AUTHORISATION NUMBER AND DATE: EU/1/16/1101 - C(2021)14720 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
2025C/516	Belgium		PRODUCT NAME: DARATUMUMAB, BORTEZOMIB, LENALIDOMIDEENDEXAMETHASON; AUTHORISATION NUMBER AND DATE: EU/1/16/1101 - C(2024)7843 20241022

Market Dynamics and Financial Trajectory for the Biologic Drug: DARZALEX

Last updated: November 7, 2025

Introduction

DARZALEX (daratumumab) has emerged as a pivotal therapy in the treatment landscape of multiple myeloma, transforming how clinicians approach this hematologic malignancy. As a monoclonal antibody targeting CD38, DARZALEX’s innovative mechanism of action has influenced both clinical practices and pharmaceutical market strategies. This analysis examines the current market dynamics, growth drivers, competitive landscape, regulatory environment, and projected financial trajectory of DARZALEX within the broader biologics sector.

Market Overview and Therapeutic Positioning

Since its FDA approval in 2015 for relapsed/refractory multiple myeloma (RRMM), DARZALEX quickly gained prominence due to its demonstrated efficacy and tolerable safety profile. It is now approved across multiple lines of therapy, including frontline settings in combination with standard regimens, broadening its market reach. According to IQVIA data, the drug’s sales surged, reflecting its rapid adoption by hematologists and oncologists worldwide.

The multiple myeloma treatment landscape remains highly dynamic, characterized by increasing diagnosis rates driven by aging populations and improved detection techniques. The disease's chronic nature necessitates long-term management strategies, often involving combination therapies incorporating DARZALEX, which enhances its market penetration.

Market Drivers

1. Expanding FDA Approvals and Label Extensions

Recent regulatory milestones have significantly expanded DARZALEX's indications:

• Frontline Combination Therapies: Approved in combination with lenalidomide and dexamethasone (Rd), and with bortezomib, melphalan, and prednisone (VMP) for newly diagnosed multiple myeloma in eligible patients.
• Maintenance Therapy: Utilization as a maintenance therapy post-autologous stem cell transplant (ASCT) underlines its role beyond refractory settings.

These approvals serve as strong growth catalysts, facilitating broader clinical adoption.

2. Evolving Standard of Care

DARZALEX's incorporation into first-line regimens has shifted the standard of care, positioning it as a cornerstone in multiple myeloma management. Such integration enhances revenue streams and supports sustained demand.

3. Market Penetration in International Territories

While the majority of sales remain concentrated in North America and Europe, emerging markets exhibit increasing adoption due to expanding healthcare infrastructure and rising disease awareness. Strategic partnerships with regional distributors accelerate this growth.

4. Combination Therapy Development

The ongoing clinical pipeline explores novel combinations—such as DARZALEX with CAR-T therapies and other immunomodulators—that aim to improve response durability. Positive trial outcomes could redefine treatment paradigms and further expand market opportunities.

Competitive Landscape

DARZALEX faces competition from other anti-CD38 monoclonal antibodies, including isatuximab (Sanofi) and elotuzumab (AbbVie), though DARZALEX’s early market entry and robust clinical data confer a competitive advantage. Additionally, emerging therapies such as BCMA-targeted CAR T-cells and bispecific antibodies threaten to reshape the treatment landscape.

However, DARZALEX’s versatility—used in multiple combination regimens and across multiple lines—fortifies its market position. Its proven efficacy, especially when combined with immunomodulatory drugs and proteasome inhibitors, sustains its dominance.

Regulatory Environment and Patent Position

Patent protected until 2026–2028 in key markets, DARZALEX benefits from exclusivity that supports premium pricing. However, biosimilar contenders are anticipated to enter markets post-patent expiry, potentially exerting downward pressure on prices and margins.

Regulatory agencies continue to review expanded indications, with data from ongoing trials reinforcing its approval portfolio. Investment in post-marketing studies maintains its scientific and commercial relevance.

Financial Trajectory and Revenue Projections

Historical Performance

Since its launch, DARZALEX has demonstrated exponential revenue growth. Takeda Pharmaceuticals reported approximately $6.1 billion in global sales for FY2022, marking it as one of the top-selling monoclonal antibodies [1]. The robust sales increase is attributed to expanded indications, combination regimens, and global uptake.

Forecasted Growth Trends

Industry analysts project compounded annual growth rates (CAGRs) of approximately 15-20% until 2027. Key factors supporting this include:

• Continued approval of new indications, especially upfront in newly diagnosed patients.
• Introduction of DARZALEX protocols in maintenance therapy, which sustains revenue over extended periods.
• Growing prevalence and diagnosis rates of multiple myeloma globally.

Impact of Biosimilar Competition

Post-patent expiration, biosimilar entrants could fragment sales, pressuring prices and margins. Nonetheless, strong brand loyalty and clinical advantages may mitigate immediate declines. Strategic initiatives, such as value-based pricing and diversified combinations, will be crucial for maintaining revenue streams.

Market Outlook by Region

• North America: Expected to remain the largest market, supported by high disease prevalence and established healthcare infrastructure.
• Europe: Steady growth anticipated as regulatory approvals increase and clinical practices align.
• Emerging Markets: Rapid growth potential exists, albeit hindered temporarily by affordability and healthcare access barriers.

Strategic Opportunities and Challenges

Opportunities

• Innovation in Combination Regimens: Combining DARZALEX with novel agents could unlock new patient populations.
• Biomarker Development: Precision medicine approaches may optimize patient selection and treatment outcomes.
• Global Expansion: Targeted market entry strategies in Asia-Pacific and Latin America could significantly increase sales.

Challenges

• Pricing and Reimbursement Pressures: Cost-containment strategies may affect margins.
• Competitive Landscape: New modalities such as bispecific T-cell engagers and CAR T-cell therapies threaten to supplant monoclonal antibodies.
• Post-Patent Biosimilar Entry: Will necessitate price adjustments and market repositioning.

Conclusion: Market Dynamics and Forward-Looking Financials

DARZALEX’s trajectory exemplifies the dynamic nature of biologic oncology therapeutics. Its rapid market adoption, expanding indications, and strategic positioning underpin a robust revenue outlook. The product’s success hinges on ongoing clinical development, geographic expansion, and navigating competitive pressures. While biosimilar competition presents risks, DARZALEX’s entrenched position as a treatment mainstay suggests sustained profitability, especially if lifecycle management strategies are effectively executed.

In a landscape marked by innovation—and imminent patent cliffs—stakeholders must remain agile. Prioritizing clinical pipeline advancements, forging strategic partnerships, and optimizing pricing strategies will be vital for maintaining long-term growth.

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Key Takeaways

• DARZALEX’s approval expansion into frontline and maintenance settings is the primary driver of its financial growth.
• The drug currently enjoys a strong market position, but impending biosimilar competition could challenge pricing and margins post-2026.
• Ongoing clinical trials exploring novel combinations and indications are vital to maintaining differentiation and market share.
• Regulatory and reimbursement environments will significantly influence future revenue trajectories, especially in emerging markets.
• Strategic diversification into global markets and innovative therapy combinations will be critical to sustain and grow DARZALEX’s profitability.

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FAQs

1. What are the main factors contributing to DARZALEX’s market dominance?
Its proven efficacy across multiple lines of therapy, expanding indications—including frontline and maintenance therapy—and early market entry have established DARZALEX as a treatment cornerstone in multiple myeloma.

2. How will biosimilar competition impact DARZALEX’s revenue?
Post-patent expiry, biosimilars are expected to exert downward pressure on prices and market share. However, brand loyalty, clinical advantage, and strategic lifecycle management can mitigate some adverse effects.

3. What are the key opportunities for DARZALEX in emerging markets?
Growing disease awareness, healthcare access improvements, and strategic partnerships can facilitate expansion, while local pricing and reimbursement frameworks remain challenges.

4. How does DARZALEX compare to its competitors?
DARZALEX benefits from earlier market entry, extensive clinical data, and multiple approved indications, positioning it favorably against competitors like isatuximab; however, novel therapies such as CAR T-cells pose additional competition.

5. What is the projected financial trajectory of DARZALEX over the next five years?
Analysts estimate a CAGR of approximately 15-20%, supported by new indications, global expansion, and sustained demand, with potential adjustments based on biosimilar market entry and innovation pipeline success.

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References

1. IQVIA. "Pharmaceutical Market Data" (2022).
2. Takeda Pharmaceuticals. "DARZALEX Annual Report 2022."
3. U.S. Food and Drug Administration. "DARZALEX Approvals and Label Updates."
4. MarketWatch. "Biologics Market Outlook and DARZALEX Revenue Projections."