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
Brazil	PI0608927
Turkey	201910145
European Patent Office	2551282
World Intellectual Property Organization (WIPO)	2006099875
France	18C1003

Supplementary Protection Certificates for daratumumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
1890004-3	Sweden		PRODUCT NAME: DARATUMUMAB; REG. NO/DATE: EU/1/16/1101 20160524
LUC00129	Luxembourg		PRODUCT NAME: DARATUMUMAB, BORTEZOMIB AND DEXAMETHASONE; AUTHORISATION NUMBER AND DATE: EU/1/16/1101/001-002 20170503
LUC00163	Luxembourg		PRODUCT NAME: DARATUMUMAB, BORTEZOMIB, THALIDOMIDE AND DEXAMETHASONE; AUTHORISATION NUMBER AND DATE: EU/1/16/1101/001-002 20200122
LUC00128	Luxembourg		PRODUCT NAME: DARATUMUMAB, LENALIDOMIDE AND DEXAMETHASONE; AUTHORISATION NUMBER AND DATE: EU/1/16/1101/001-002 20170503
18C1003	France		PRODUCT NAME: DARATUMUMAB; REGISTRATION NO/DATE: EU/1/16/1101 20160524

Daratumumab Market Dynamics and Financial Trajectory (Revenue, Share, Exclusivity, and Competitive Impact)

Last updated: May 19, 2026

Daratumumab revenue is being reshaped by (1) expanded indications and combination regimens, (2) subcutaneous (SC) and less-frequent dosing adoption, (3) competitive pressure from other multiple myeloma biologics and emerging CD38 alternatives, and (4) originator patent and regulatory exclusivity durability that has delayed biosimilar buildout versus what the category’s earlier entrants experienced. The financial trajectory is structurally tied to ongoing cohort-level uptake of daratumumab-based frontline and relapsed settings, and to cost and administration economics of IV to SC switching.

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How much revenue does daratumumab generate and what is its financial trajectory by line of therapy?

Featured snippet answer: Daratumumab’s financial trajectory has followed a “volume expansion first, price and mix later” profile, with major revenue contributions coming from multiple myeloma across first-line and relapsed disease where daratumumab-based combinations became standard-of-care, then shifting toward SC uptake and regimen consolidation as competition intensified.

Revenue architecture: the drivers

• Regimen penetration: Use in induction, consolidation, and maintenance in combination with backbone therapies (commonly proteasome inhibitors, immunomodulatory agents, and corticosteroids) drives durable patient cohorts.
• Dosing convenience and site-of-care economics: SC administration reduces infusion time and supports broader clinic capacity and throughput versus IV.
• Line-of-therapy expansion: Each incremental indication or therapy placement increases the addressable treated population and stabilizes revenue even when pricing pressure emerges.
• Safety and operational fit: Real-world continuation rates and reduced infusion burden support repeat dosing schedules and reduced discontinuation.

What typically moves quarterly revenue

• Uptake of SC initiation in existing patients and conversion from IV.
• Growth in new patient starts in newly adopting regions and centers.
• Indication cycle effects around label expansions and guideline adoption.
• Inventory and channel timing around major tender cycles, drug acquisition costs, and reimbursement changes.

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What patents and exclusivity protect daratumumab, and when do they start to erode?

Featured snippet answer: Daratumumab’s protection is maintained by a layered estate: composition and biologic product claims, manufacturing/method claims, and jurisdiction-specific regulatory exclusivities tied to FDA licensure pathways for biologics. The practical timeline for biosimilar entry depends on both patent expiry and biosimilar/market authorization triggers.

FDA exclusivity and biosimilar entry mechanics

• Biologics license exclusivity: FDA’s 12-year BLA exclusivity blocks FDA approval of biosimilars for the reference product for the conditions of approval unless a pathway-specific exception applies.
• Nonproprietary exclusivity: Additional exclusivities may affect which claims can be approved.
• Patent litigation: For biosimilars, the launch schedule is often constrained by the outcome of patent litigation or agreement-triggered “licensed launch” timing.

Patent landscape: how the estate is usually structured for daratumumab

• Product and formulation: claims over the antibody composition, concentration ranges, excipients, and SC or IV presentation parameters.
• Manufacturing: claims over cell line, purification, formulation processes, and controls.
• Method-of-use and regimens: claims over therapeutic uses in myeloma and combinations.

Timing erosion is uneven across geographies

• Patent expirations happen on different calendars across the US, EU, UK, JP, and major commercialization markets.
• Biosimilar progress can vary materially by region because litigation strategies, court timelines, and local procedural rules differ.

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What is the Orange Book status of daratumumab and does it affect generic competition risk?

Featured snippet answer: Daratumumab is a biologic and is typically listed in FDA’s biologics databases, not the Orange Book in the same way small-molecule drugs are. The competitive risk is primarily driven by biosimilar pathways and patent challenges, not “generic” substitution.

Practical implication for “generic” risk

• Automatic substitution is not the same for biologics as for generics.
• Competitive pressure generally comes from biosimilar approvals and payer switching policies rather than generic dispensing.

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Which daratumumab biosimilars and copycats are the biggest market risk, and when could they enter?

Featured snippet answer: Biosimilar competition is the principal risk channel for daratumumab’s reference product economics, with market entry timing determined by FDA approvals (if authorized), patent litigation outcomes, and payer contracting behavior.

How biosimilar pressure typically reaches the market

• Payer formulary inclusion: switching incentives can appear quickly after approval.
• Hospital contracting: group purchasing organization terms can accelerate adoption.
• Physician and patient comfort: originator loyalty and operational familiarity often slow uptake.

What to watch in biosimilar buildout

• Availability of SC biosimilar presentation (since administration convenience is a revenue lever for the reference product).
• Interchangeability status (in jurisdictions where it matters for switching).
• Launch sequencing across US and EU, because it affects benchmarking and payer expectations.

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How do daratumumab market dynamics differ between IV and SC dosing?

Featured snippet answer: SC delivery changes both economics and adoption mechanics by improving throughput and reducing infusion-center capacity constraints, which tends to support revenue stability even when average pricing is pressured.

IV to SC switching: financial consequences

• Cost-to-admin declines (less infusion time, potentially fewer staffing hours).
• Continuity advantage: patients already stabilized in daratumumab regimens can switch without changing backbone therapy.
• Site expansion: SC can enable more administration in community settings.
• Mix shift: higher SC share can preserve revenue per patient by stabilizing demand and simplifying contracting.

Competitive consequence

• Biosimilars with SC versions can compete more directly on “real-world operational value.”
• If biosimilar launches lag SC readiness, the originator’s operational moat can persist longer.

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Which combinations and indications contribute most to daratumumab revenue, and what is the competitive impact?

Featured snippet answer: Daratumumab revenue is concentrated in multiple myeloma combinations where CD38 targeting delivers depth of response, and where daratumumab-based regimens have become standard choices across relapse and selected frontline settings.

Line-of-therapy categories that typically dominate sales

• Frontline myeloma: CD38 backbone adoption where daratumumab is incorporated into induction and maintenance strategies.
• Relapsed/refractory: regimen use with multiple partner classes, creating switching opportunities and cross-line reuse.

Regimen substitution risk

• Competitors in the CD38 class and alternative novel mechanisms can shift patient starts if they demonstrate superior overall response durability, tolerability, or logistics.
• However, once a regimen is established in treatment pathways and payer algorithms, switching can be slow unless clinical benefit is substantial and operational factors align.

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What patent litigation affects daratumumab and how does it shape biosimilar timing?

Featured snippet answer: Litigation and settlement agreements are the primary determinants of biosimilar launch timing for biologics, often resulting in delayed entry even after technical approval pathways become available.

Where litigation typically changes the revenue curve

• Automatic stay / procedural timing: affects “earliest launch date.”
• Damages exposure: can change settlement terms and thus the speed of market entry.
• Scope of injunctions: some patents block only certain product configurations (for example, formulation or SC presentation), leaving partial competitive entry still possible.

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How strong is the daratumumab patent estate for formulations, manufacturing, and method-of-use?

Featured snippet answer: The estate strength generally depends on whether competitors can design around claims related to formulation presentation (especially SC), and whether manufacturing process claims meaningfully constrain biosimilar comparability.

Estate components that often matter most commercially

• Formulation and delivery system: SC vs IV can be a separate competitive axis.
• Process controls: manufacturing claims can create practical barriers even when sequence and general mechanism are known.
• Method-of-use: combination-specific claims can influence whether biosimilar entrants can market against certain regimen settings.

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How does daratumumab compare with other multiple myeloma biologics on market share dynamics?

Featured snippet answer: Daratumumab’s market dynamics reflect its position as a CD38 anchor with broad regimen coverage, while peers often compete on either niche differentiation (specific relapse settings or particular partner choices) or on throughput advantages through their own administration models.

Competition channels

• Within CD38 targeting: direct mechanism rivalry can compress price and contracting leverage.
• Across novel MoAs: competitors can win patient starts, pushing daratumumab toward later lines or reduced combination share.
• Administration and convenience: IV duration and SC availability affect center preference and payer negotiations.

Expected effects on trajectory

• Early competition pressure reduces new starts more quickly than it reduces continuation, producing a “decline after peak starts” pattern.
• SC adoption helps slow the erosion by improving operational value even as competition increases.

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What commercial deal patterns and payer behaviors influence daratumumab profitability?

Featured snippet answer: Payer contracting and hospital purchasing models are the principal levers for net price. Daratumumab’s profitability is sensitive to rebates, outcomes-based terms, and competitive tendering in major oncology centers.

Factors that change net pricing

• Biosimilar-ready contracting: payers may implement “pre-switch” clauses.
• Tender cycles: oncology drug supply contracts frequently rebid; winning strategy shifts with competitor price points.
• Mix effects: more SC share can improve patient throughput and support higher uptake even if discounts rise.

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What are the key barriers for biosimilar manufacturing and interchange of daratumumab?

Featured snippet answer: Manufacturing comparability, formulation control (especially for SC), and quality consistency are the operational barriers that can delay biosimilar scale-up and limit rapid market substitution.

Key execution risks that affect launch readiness

• Control of glycosylation and product heterogeneity consistent with reference product.
• Formulation stability for the SC product.
• Batch-to-batch consistency and release specification tightness.
• Cold-chain and distribution requirements across regions.

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When does daratumumab lose exclusivity in major jurisdictions and what does that mean for market share?

Featured snippet answer: Exclusivity loss in major jurisdictions typically triggers accelerated biosimilar price competition and payer switching, but the pace of share transfer depends on (1) whether SC biosimilar versions are ready, (2) settlement-driven launch dates, and (3) local payer willingness to switch.

Market share shift mechanics after exclusivity expiry

• Near-term: biosimilar launches gain access via formulary inclusion, but share uptake is phased.
• Mid-term: if multiple biosimilars enter, competitive bidding intensifies and net price falls faster.
• Long-term: originator may retain share via patient/physician preference, center conversion inertia, and contracting constraints.

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Key Takeaways

• Daratumumab’s revenue trajectory is primarily driven by expansion and durability of multiple myeloma combination use, with SC adoption supporting operational value and revenue stability as pricing pressure increases.
• The largest competitive risk is biosimilar entry timing, which is constrained by a layered combination of FDA biologics exclusivity and patent litigation outcomes, with jurisdiction-specific variation.
• IV-to-SC conversion is a critical commercial determinant because it changes administration economics and influences the competitiveness of both the reference product and biosimilar alternatives.
• Market share erosion tends to be delayed relative to exclusivity expiry due to payer contracting cycles, physician practice patterns, and interchange/switching mechanics.

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FAQs

1. How do payers decide when to switch from daratumumab IV to SC or to a biosimilar?
2. Which daratumumab indications are most vulnerable to biosimilar-driven contracting?
3. What product attributes most affect biosimilar competitiveness for daratumumab (SC formulation, dosing schedule, stability)?
4. How do patent settlement terms typically change the earliest biosimilar launch date for monoclonal antibodies like daratumumab?
5. What factors determine whether a competitor’s multiple myeloma regimen displaces daratumumab in frontline versus relapsed settings?

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References

1. US Food and Drug Administration. BLA and biologics exclusivity framework and biosimilar pathways. FDA website.
2. FDA. Drugs@FDA database entries for daratumumab-containing products and regulatory status. FDA website.
3. FDA. Purple Book guidance and biologics interchange and labeling resources. FDA website.
4. FDA. Biosimilar approval pathway resources and information on patent-related exclusivity and litigation framework. FDA website.