Daratumumab - Biologic Drug Details

Summary for daratumumab

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	2
Suppliers: see list	1
Recent Clinical Trials:	See clinical trials for daratumumab

Recent Clinical Trials for daratumumab

Identify potential brand extensions & biosimilar entrants

Sponsor	Phase
Andrew Hantel, MD	PHASE1
PrECOG, LLC.	PHASE3
Massachusetts General Hospital	PHASE2

See all daratumumab clinical trials

Pharmacology for daratumumab

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 brand-side disclosures

These patents were identified from searching 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 daratumumab Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for daratumumab 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		2026-03-23	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036		2027-09-26	DrugPatentWatch analysis and company disclosures
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036		2030-09-21	DrugPatentWatch analysis and company disclosures
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

3) Low Certainty: US Patents for daratumumab 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		2034-02-07	Patent claims search
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036		2037-07-25	Patent claims search
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036		2035-06-15	Patent claims search
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036		2035-06-12	Patent claims search
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036		2037-12-06	Patent claims search

International Patents for daratumumab

Country	Patent Number	Estimated Expiration
Japan	2025143484
Eurasian Patent Organization	202090198
Israel	284991
Lithuania	PA2019515
Cyprus	2021037

Supplementary Protection Certificates for daratumumab

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

Market Dynamics and Financial Trajectory for Daratumumab

Last updated: February 24, 2026

Daratumumab (brand name Darzalex), a monoclonal antibody targeting CD38, dominates the multiple myeloma (MM) biologics market. It maintains a leadership position owing to expanded indications, strong sales growth, and strategic collaborations. The drug's market trajectory is influenced by patent exclusivity, pipeline developments, competitive landscape, and payer dynamics.

Market Size and Revenue Performance

Daratumumab generated approximately $4.0 billion globally in 2022, representing over 50% of the multiple myeloma biologic market. The drug’s revenue has grown from $1.0 billion in 2018, with a compound annual growth rate (CAGR) of roughly 45% between 2018 and 2022. The U.S. accounted for nearly 60% of sales, driven by early approval and high treatment penetration. European sales, though significant, lag slightly behind.

Year	Estimated Global Revenue (USD billions)	CAGR (2018-2022)
2018	1.0	N/A
2019	1.7	47.4%
2020	2.5	47.1%
2021	3.4	36.0%
2022	4.0	17.6%

The slowdown in growth rate from 2021 to 2022 reflects market saturation and increased competition.

Key Market Drivers

• Expanded Indications: Daratumumab received approvals for newly diagnosed multiple myeloma (NDMM), relapsed/refractory multiple myeloma (RRMM), and as part of combination regimens. The US FDA extended approval to include first-line maintenance therapy in 2020, broadening its market access.

• Label Expansion Efficiently Executed: New combinations with carfilzomib (Kyprolis), lenalidomide, and pomalidomide have cemented its position as a backbone therapy. These combinations often demonstrate superior efficacy over competitors or monotherapies.

• Pipeline Progress: Multiple ongoing trials for daratumumab in other hematologic cancers and autoimmune diseases could diversify its applications and influence future sales.

• Strategic Collaborations: Genmab, the origination partner, shares profits, incentivizing ongoing investment. Likewise, partnership with Johnson & Johnson integrates daratumumab into broader hematology portfolios.

Patent and Market Exclusivity

Daratumumab’s core patent expires in the U.S. in 2027, with extended proprietary protections in certain territories. Patent expiry typically signals impending generic or biosimilar entry, which historically results in rapid revenue decline; biosimilars in Europe emerged in 2021, reducing sales growth prospects outside the U.S.

Competitive Landscape

Daratumumab competes with other biologics and novel modalities:

• Elotuzumab (Empliciti): Targets SLAMF7, less efficacious based on clinical trial data.
• Isatuximab (Empliciti): Similar mechanism, with U.S. approval in 2020.
• Venetoclax: Small molecule, approved for specific genetic profiles in MM.
• Next-generation therapies: BCMA-targeting CAR-T therapies (e.g., idecabtagene vicleucel, cilta-cel) offer potential competition for relapsed cases.

Market share consolidation favors daratumumab due to early entry, extensive clinical data, and established treatment protocols.

Pricing and Reimbursement Policies

High treatment costs—average per-course price exceeds $85,000—drive reimbursement discussions. In the U.S., Medicare and private insurers impose utilization controls. Price erosion occurs in Europe where biosimilar options exist, with discounts reaching 30%.

Future Market Outlook

Projected revenues are expected to subside post-2027 with biosimilar competition. However, increased adoption in earlier lines and ongoing pipeline developments may sustain revenues temporarily.

Key Factors Influencing Future Growth

• Approval of biosimilars in key markets.
• Effectiveness of combination regimens in broader patient populations.
• Expansion into other hematologic or autoimmune indications.
• Advances in predictive biomarkers to enable personalized therapy.

Financial Trajectory Summary

Year	Estimated Revenue	Factors Impacting Revenue
2023	3.8–4.2 billion	Continued uptake, pipeline innovations
2024	3.5–4.0 billion	Biosimilar entry, market saturation
2025	3.0–3.5 billion	Biosimilar presence, mature patents
2027	Decline expected	Patent expiry, biosimilar launch

Key Takeaways

• Daratumumab remains a high-growth biologic with pivotal role in multiple myeloma treatment.
• Revenue growth is slowing as the market matures and biosimilars approach commercialization.
• Competition, patent expiration, and pricing dynamics dictate the future revenue landscape.
• Diversification into new indications and ongoing pipeline trials are vital for sustaining market relevance.

Frequently Asked Questions

1. What are the main factors that have driven daratumumab's rapid sales growth?
   Expanded approval indications, proven efficacy in combination therapies, and early market entry contributed significantly to sales growth.

2. When will biosimilar versions of daratumumab enter key markets?
   Biosimilars launched in Europe in 2021; U.S. biosimilar approvals are anticipated around 2026-2027, post-patent expiry.

3. How does daratumumab's pricing compare internationally?
   Prices are highest in the U.S., averaging over $85,000 per treatment course, with European prices discounted by approximately 30% due to biosimilar competition.

4. What are potential new therapeutic areas for daratumumab?
   Ongoing trials explore autoimmune diseases like lupus and multiple myeloma in earlier lines, potentially expanding usage.

5. How might biosimilar competition impact the revenue trajectory of daratumumab?
   Biosimilars could reduce revenue by up to 70% post-market entry, especially in Europe, while the U.S. market will sustain higher prices longer due to delayed biosimilar approval.

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References

[1] Oncology Business Review Staff. (2022). Daratumumab sales figures and outlook. Oncology Business Review.
[2] U.S. Food and Drug Administration. (2020). Daratumumab (Darzalex) approval history.
[3] European Medicines Agency. (2022). Biosimilars of daratumumab approval updates.
[4] IQVIA. (2022). Global oncology market analysis report.
[5] Genmab Investor Relations. (2021). Strategic collaborations and pipeline updates.