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
Australia	2006226733
Brazil	PI0608927
Canada	2602375
China	101218256
China	107033243

Supplementary Protection Certificates for Daratumumab

Supplementary Protection Certificate	SPC Country	SPC Expiration	SPC Description
2021C/555	Belgium		PRODUCT NAME: DARATUMUMAB, CYCLOFOSFAMIDE, BORTEZOMIB EN DEXAMETHASON; AUTHORISATION NUMBER AND DATE: EU/1/16/1101 - C(2021)14720 20210623
C02081595/01	Switzerland		PRODUCT NAME: DARATUMUMAB; REGISTRATION NO/DATE: SWISSMEDIC-ZULASSUNG 66072 07.09.2017
CA 2019 00046	Denmark		PRODUCT NAME: DARATUMUMAB, BORTEZOMIB OG DEXAMETHASON; REG. NO/DATE: EU/1/16/1101/001-002 20170503
CA 2021 00051	Denmark		PRODUCT NAME: DARATUMUMAB, CYCLOPHOSPHAMID, BORTEZOMIB OG DEXAMETHASON; REG. NO/DATE: EU/1/16/1101 20210623
2019C/010	Belgium		PRODUCT NAME: DARATUMUMAB,LENALIDOMIDE AND DEXAMETHASON; AUTHORISATION NUMBER AND DATE: EU/1/16/1101 20170503

Daratumumab market dynamics and financial trajectory (sales trends, share drivers, payer exposure, and exclusivity risk)

Last updated: July 22, 2026

Daratumumab (Janssen Biotech/AbbVie), the backbone CD38 franchise in multiple myeloma, is transitioning from peak growth to a mature-to-declining sales profile as (1) patient mix shifts to earlier lines with constrained net prices, (2) competitors expand with CD38 and BCMA/other MOA regimens, and (3) biosimilar and volume-access pressure increases in key markets. Financial trajectory has been dominated by expansion across settings (relapsed/refractory, first-line combinations, and maintenance-like use), then moderated by evidence-driven regimen substitution, dosing schedule pressure, and channel stocking/settlement effects.

What drives daratumumab market dynamics in multiple myeloma (share, mix, and net price)?

Daratumumab is the CD38 anchor used in combination regimens across relapsed/refractory and front-line multiple myeloma. Market dynamics follow a repeatable pattern across countries: uptake accelerates after label expansion and guideline adoption, then slows as prescribers incorporate alternatives and payers steer toward lower-cost regimens.

Key demand drivers

• Line-of-therapy expansion: Daratumumab moved from refractory disease into earlier lines, increasing eligible patient populations and treatment duration in some regimens.
• Combination depth: Daratumumab’s most durable growth periods came from combination use where clinical efficacy translated into guideline inclusion.
• Treatment standardization: Once regimen templates became routine (e.g., daratumumab-based induction with ongoing dosing in maintenance-like phases), physicians maintained use even when competitors launched.

Key supply and channel drivers

• Net price pressure: CD38-to-CD38 and MOA-to-MOA competition has tightened payer access. Net pricing is typically more elastic in later disease and where biosimilars or lower-cost options appear.
• Reimbursement steering: Formularies and prior authorization requirements increasingly favor preferred regimens, forcing regimen substitution even when clinical outcomes are similar.

How have daratumumab sales evolved over time (peak, plateau, and decline phases)?

Daratumumab has moved through three broad sales phases in most markets:

1. Expansion and label capture: Strong growth as indications broadened and combinations penetrated.
2. Maturity and pricing normalization: Growth decelerated as peak patient adoption saturated and net pricing adjusted to payer pressure.
3. Erosion from competition and biosimilar effect: When biosimilar availability or comparable alternatives became accessible, volumes became more contestable and net revenue growth turned to contraction.

Regional financial effects that typically matter

• US: The largest revenue pool with high payer heterogeneity. Net revenue sensitivity is high to contracting, AMP-based dynamics, and uptake of lower-cost alternatives.
• EU5 and other large ex-US markets: Where tendering and hospital procurement can accelerate volume shifts once biosimilars appear.
• China and Japan: Adoption depends on local reimbursement and sequencing of approvals, with payer and guideline structure driving uptake timing.

What is daratumumab’s financial trajectory in the US (payer pressure, contracting, and volume shifts)?

In the US, daratumumab’s financial trajectory hinges on three levers: (1) dosing and regimen duration per patient, (2) payer coverage and contracting, and (3) competitive switching to alternative regimens.

Net sales sensitivity points

• Mix shift by line of therapy: Earlier line use increases treated patients but can compress net pricing through broader competition and tighter payer controls.
• Maintenance-like dosing intensity: Any shift away from prolonged dosing schedules can reduce units and complicate revenue maintenance.
• Contracting cadence: Large managed-care contracts create stepwise changes in net price and patient access, producing quarterly volatility.

Competitive switching risk

• Physicians can switch within the same class (CD38) or across mechanisms (BCMA-targeted therapies and non-BCMA constructs), especially when payers narrow formularies.

Which rivals drive daratumumab revenue pressure (CD38 and non-CD38 competitors)?

Daratumumab’s economic position is competed by two buckets: CD38 biosimilars and alternative anti-myeloma regimens with different MoA that can replace daratumumab in key treatment templates.

CD38 competitive set

• Other anti-CD38 antibodies (where available) and biosimilar daratumumab products in markets with biosimilar launches.

Non-CD38 competitive set

• BCMA-targeted therapies (including antibody-drug conjugates, bispecific antibodies, and CAR-T pathways that restructure sequencing).
• Other immunomodulatory and proteasome inhibitor combinations that remain cost-sensitive options in certain payer segments.

What does daratumumab biosimilar risk mean for market share and margins?

Biosimilar risk typically produces:

• Share dilution: Volume shifts when biosimilars are preferred via contracting and tendering.
• Price compression: Net prices decline as multiple contracting options exist.
• Channel management: Remaining originator demand may become more concentrated in patients where prior response history or access friction delays switching.

Where biosimilar effects are strongest

• Hospital procurement economies in EU and other systems with tendering.
• Managed care formularies in the US once biosimilars are included as preferred options.
• After switching becomes operationally easy through stable prescribing patterns and pharmacy distribution.

How does daratumumab compare with other multiple myeloma biologics financially (market maturity vs growth)?

A useful financial comparison is between:

• Mechanism anchors with broad guideline presence (daratumumab historically) versus
• MOA platforms with fast modality substitution (e.g., bispecific or ADC-led sequencing changes that compress use of antibody backbones).

Daratumumab’s advantage has been breadth across lines and combinations, which supports unit volume. Its disadvantage is that mature class positioning makes it vulnerable to biosimilar discounting and regimen redesign when new modalities show superior response depth or convenience.

When do key exclusivity and patent cliffs affect daratumumab revenue (US timeline and trigger points)?

Daratumumab is a mature product where most meaningful exclusivity effects have already played out, and near-term revenue risk is less about primary exclusivity and more about:

• Patent scope for specific formulations, dosing regimens, manufacturing, and method-of-use
• Biosimilar/biologic competition entry windows
• Litigation and settlement-driven entry timing

Key revenue risk mechanics

• Orange Book and biologic exclusivity interaction: For innovator biologics, patent and exclusivity frameworks combine with biosimilar pathways to set effective entry timing.
• Settlement impact: Resolved disputes can set “carve-out” dates that delay or accelerate biosimilar uptake.

What is the Orange Book status of daratumumab and how does it relate to generic/biosimilar entry?

Daratumumab is a biologic; the practical “entry” question is about biosimilars rather than generic drugs. The relevant framework is:

• US patent estate listings (Orange Book for small molecules; biologics use patent listings in the relevant FDA systems and associated publication)
• Biosimilar approval pathway (BLA 351(k))
• Litigation/settlement timing that can govern “at-risk” launch and switching.

A full Orange Book-style mapping requires product and NDA/BLA identifiers, patent numbers, and listed expiration dates to determine trigger points. Without that product-specific patent listing dataset in the record, a complete date-by-date cliff analysis cannot be produced here.

How strong is the patent estate for daratumumab (what is typically protected)?

For daratumumab, patent estates in biologics usually cover:

• Formulations and concentrations tied to administration and stability
• Methods of use in specific line-of-therapy and combination regimens
• Manufacturing and process controls (cell culture, purification, filling)
• Device and dosing regimens if supported by evidence

Financially, the estate matters less as a binary “expired/not expired” switch and more as a determinant of how quickly biosimilars can launch in practice, whether interchangeability is accepted by payers, and whether method-of-use claims constrain substitution.

What patent litigation affects daratumumab market access (and when do settlements change entry)?

Biologic competition in multiple myeloma often hinges on:

• Infringement disputes that delay biosimilar launching
• Compromise settlement terms (timing triggers and scope limits)
• Ongoing appeals and continuations that extend uncertainty

A litigation-aware revenue outlook requires docketed case history tied to the specific parties and products. That mapping cannot be completed without a case list and settlement terms.

What formulations are protected for daratumumab (subcutaneous vs intravenous economics)?

Dosing modality affects:

• Patient throughput (clinic chair time vs home or alternate infusion workflows)
• Adherence and persistence
• Distribution and billing patterns
• Payer preference for lower-cost administration settings

If a protected subcutaneous formulation or specific dosing schedule is involved, biosimilar entry or “switchability” can be delayed in regions where payers require proven interchangeability to switch.

A precise formulation-level patent inventory cannot be provided here without the specific formulation patent numbers and the subcutaneous/IV product listing set.

What generic entry risks exist for daratumumab (biosimilar substitution, not small-molecule generics)?

For daratumumab, the entry risk is biosimilar and interchangeability substitution, not chemical genericization. Generic-like risk manifests as:

• Biosimilar launches under 351(k)
• Managed-care and hospital switching
• Payer-driven substitution after evidence and contracting cycles

Financially, the key question is effective market share capture by biosimilars and the speed of price normalization.

How do payer and reimbursement structures change daratumumab financial outcomes?

Payer behavior shapes revenue more than clinical adoption in mature markets:

• Prior authorization and utilization management slow new starts and can reduce maintenance persistence.
• Site-of-care incentives shift administration patterns toward lower-cost delivery settings.
• Bundled contracting can create discontinuous impacts on net price and volume.

Commercial outlook: what happens to daratumumab revenues under continuing competition?

Base-case financial direction for a mature originator biologic facing biosimilar expansion is:

• Top-line pressure from price compression and share dilution.
• Stabilization only if originator retains strong guideline anchoring, achieves favorable contracting, or sustains differentiation through administration mode, persistence, and patient outcomes.
• Higher volatility as contracting changes and competitive sequencing cycles.

In multiple myeloma, sequencing remains dynamic: if payers move toward regimens that reduce reliance on a CD38 antibody backbone, originator volumes can decline even before biosimilar share becomes the dominant driver.

Key Takeaways

• Daratumumab’s market has matured from label-driven expansion into a competition-driven environment where net pricing, regimen substitution, and biosimilar uptake control the financial arc.
• The economic trajectory is shaped by line-of-therapy mix, maintenance-like dosing persistence, and payer contracting cadence.
• Revenue risk is primarily biosimilar and regimen substitution, not “generic” competition.
• Near-term financial performance depends on how quickly patient volumes shift away from daratumumab-based templates and how aggressively biosimilars and alternative MOA regimens displace it.

FAQs

1. How does line-of-therapy sequencing affect daratumumab net sales vs unit volumes?
2. What contractual mechanisms typically drive step-down net price for daratumumab in the US?
3. When biosimilars launch, how quickly do hospitals and managed care switch daratumumab patients?
4. Does subcutaneous vs IV administration materially change daratumumab persistence and revenue?
5. How do BCMA-targeted bispecifics and ADCs influence daratumumab regimen share in earlier lines?

References

1. FDA. “Biosimilar Product Information.” U.S. Food and Drug Administration.
2. FDA. “Biologics License Application (BLA) and 351(k) Pathway.” U.S. Food and Drug Administration.
3. Janssen (AbbVie). Darzalex (daratumumab) Prescribing Information and label history.
4. AbbVie / Janssen. Financial reports and investor presentations for daratumumab and multiple myeloma franchise performance.