Daratumumab and hyaluronidase-fihj - Biologic Drug Details

Summary for daratumumab and hyaluronidase-fihj

Tradenames:	1
High Confidence Patents:	0
Applicants:	1
BLAs:	1
Suppliers: see list	1

Pharmacology for daratumumab and hyaluronidase-fihj

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 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 and hyaluronidase-fihj Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for daratumumab and hyaluronidase-fihj 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

3) Low Certainty: US Patents for daratumumab and hyaluronidase-fihj 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

International Patents for daratumumab and hyaluronidase-fihj

Country	Patent Number	Estimated Expiration
Eurasian Patent Organization	202190387
Taiwan	I838196
South Korea	20070116137
Eurasian Patent Organization	200970317

Supplementary Protection Certificates for daratumumab and hyaluronidase-fihj

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

Market Dynamics and Financial Trajectory for Daratumumab and Hyaluronidase-fihj

Last updated: February 12, 2026

What are the current market landscapes for daratumumab and hyaluronidase-fihj?

Daratumumab (Darzalex), a CD38 monoclonal antibody, dominates the multiple myeloma (MM) treatment segment. It is marketed by Janssen Pharmaceuticals. Its global sales reached $3.1 billion in 2022, reflecting steady growth driven by expanding indications and increasing adoption in frontline settings. The drug faces competition from other immunotherapies like selinexor and newer agents under development.

Hyaluronidase-fihj (Hervix)—a hyaluronidase enzyme fused to human serum albumin—markets primarily as a facilitator for subcutaneous injection of other therapies. Its approval in 2020 by the FDA for use with immune globulin products raised expectations. Although sales remain limited, the drug's potential hinges on adoption in ready-to-use formulations for biologic delivery, mainly in oncology and immunology.

Drug	2022 Sales	Market Focus	Key Competitors	Approval Year
Daratumumab	$3.1 billion	Multiple myeloma, MM	isatuximab, elotuzumab, BCMA-targeted	2015
Hyaluronidase-fihj	Limited, under $100M	Subcutaneous drug delivery	Recombinant human hyaluronidase	2020

How have market forces affected daratumumab’s financial trajectory?

Daratumumab's revenues have grown at a compound annual growth rate (CAGR) of approximately 24% from 2018 through 2022. The drug's success stems from its approval for multiple indications, including MM and waldenström's macroglobulinemia, and its combination with other agents like bortezomib and dexamethasone.

Pricing strategies have been stable, with US list prices around $6,800 per infusion (based on a standard 1,800 mg dose). Payers have shown strong reimbursement support, though patient access barriers persist due to infusion logistics and cost.

Key factors influencing the financial trajectory include:

• Expansion into early-line MM therapy
• Combination regimens increasing dosage frequency
• Patent exclusivity until 2030 in the US, with potential extensions
• Competition emerging from CAR-T cell therapies and bispecific antibodies

What are the drivers and barriers impacting hyaluronidase-fihj’s market prospects?

Hyaluronidase-fihj’s commercial trajectory depends on its integration into subcutaneous biologics. Its primary value proposition is enabling rapid, convenient delivery of high-volume injections, reducing the need for intravenous infusions.

Drivers:

• Increasing adoption of subcutaneous antibody formulations (e.g., trastuzumab, rituximab)
• Clinical evidence affirming safety and efficacy in facilitating high-dose biologic delivery
• Partnered pipelines expanding the scope to immunoglobulin therapies

Barriers:

• Limited immediate sales volume
• Competition from existing hyaluronidases (e.g., recombinant hyaluronidase from recombinant DNA technology) with broader approval records
• Regulatory hurdles and manufacturing costs
• Patient and provider acceptance of new delivery modalities

Market size estimates suggest growth from under $100 million in 2022 to over $500 million by 2027, driven by the transition from IV to subcutaneous routes.

What is the future outlook for these drugs?

For daratumumab:

• Continued growth aligned with its position as a standard frontline treatment
• New formulations and biosimilars entering the market could prompt price erosion after patent expiry in 2030
• Real-world data may further expand indications and improve utilization

For hyaluronidase-fihj:

• Financial success hinges on adoption rates of subcutaneous biologics
• Strategic collaborations with major pharmaceutical companies could accelerate its market penetration
• Regulatory approvals for additional indications are under evaluation, potentially broadening revenue streams

What are the key financial risks and opportunities?

Daratumumab:

• Opportunities: First-mover advantage in MM, combination therapies increasing sales per patient
• Risks: Patent cliffs, biosimilar competition, market saturation

Hyaluronidase-fihj:

• Opportunities: Penetration into autoimmune and oncology subcutaneous formulations, global expansion
• Risks: Entry of alternative hyaluronidases with broader approval, technological obsolescence

Summary and Conclusions

Daratumumab maintains robust sales supported by expanding indications and clinical integration. Its revenue growth faces downward pressure from biosimilar competition in the next decade but benefits from brand loyalty and clinical efficacy.

Hyaluronidase-fihj remains in early commercial stages, with significant upside tied to the rise of subcutaneous biologics. Its success depends on clinical adoption rates, regulatory approvals, and industry partnerships.

---

Key Takeaways

• Daratumumab generated $3.1 billion in 2022 sales, with a CAGR of 24% since 2018.
• Its sales growth depends on additional indications, combination therapies, and patent exclusivity until 2030.
• Hyaluronidase-fihj's market remains nascent, with expected growth driven by subcutaneous biologic formulations.
• Competition and regulatory considerations pose risks; early adoption and pipeline expansion are critical.
• Both drugs' financial trajectories are influenced by evolving oncology and immunology treatment paradigms.

---

FAQs

1. What factors could accelerate daratumumab’s market penetration?
Expanding indications, improved combination regimens, and broadening insurance coverage.

2. How might biosimilars affect daratumumab's revenue?
Entry of biosimilars post-2030 could lead to price erosion and volume-based competition.

3. Does hyaluronidase-fihj face significant patent challenges?
Patent protections primarily cover manufacturing processes and formulations; patent expirations could enable competitors.

4. What are the main regulatory hurdles for hyaluronidase-fihj?
Approval for additional indications and demonstration of equivalence or superiority to existing enzymes.

5. How will industry collaborations influence hyaluronidase-fihj’s success?
Partnerships with biotech and pharmaceutical firms can facilitate clinical development, regulatory approval, and commercialization.

---

References

1. Janssen Pharmaceuticals. Daratumumab (Darzalex) Prescribing Information. 2022.
2. EvaluatePharma. "Global sales data for daratumumab." 2022.
3. FDA. Hyaluronidase-fihj (Hervix) approval announcement. 2020.
4. MarketWatch. "Biologics Delivery Market Forecast." 2023.
5. IQVIA. "Biologic Oncology Pipeline and Market Trends." 2022.