DARZALEX Drug Profile

Summary for Tradename: DARZALEX

High Confidence Patents:	0
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
Georgetown University	Phase 2
Indapta Therapeutics, INC.	Phase 1/Phase 2
Wuhan Union Hospital, China	Phase 2

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. General 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 DARZALEX Derived from Brand-Side Litigation

No patents found based on brand-side litigation

2) High Certainty: US Patents for DARZALEX Derived from 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		2025-03-23	Company disclosures
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036		2027-09-26	Company disclosures
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036		2030-09-21	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		2033-02-08	Patent claims search
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036		2035-05-04	Patent claims search
Janssen Biotech, Inc.	DARZALEX	daratumumab	Injection	761036		2034-06-16	Patent claims search

Market Dynamics and Financial Trajectory for DARZALEX

Introduction to DARZALEX

DARZALEX, developed by Genmab and marketed by Johnson & Johnson (J&J), is a monoclonal antibody used in the treatment of multiple myeloma, a type of blood cancer. Since its approval in 2015, DARZALEX has become a cornerstone in the treatment of this disease, and its impact on the market is significant.

Current Market Performance

As of 2024, DARZALEX continues to show strong sales performance. In the first nine months of 2024, net sales of DARZALEX, including its subcutaneous formulation DARZALEX Faspro, reached $8.586 billion, a 19% increase from the same period in 2023[5].

Revenue Growth and Projections

The revenue generated by DARZALEX has been steadily increasing. In 2021, the drug achieved sales of $6 billion, and in 2023, it was on track to approach $10 billion in revenue[2]. Bloomberg Intelligence (BI) predicts that DARZALEX sales will hit $14.7 billion by 2030, although this figure is slightly below the consensus of other analysts due to anticipated price cuts under the Inflation Reduction Act in 2029[1].

Market Share and Dominance

DARZALEX is expected to dominate the multiple myeloma market in the coming years. By 2030, BI forecasts that almost half of the market will be accounted for by J&J-Genmab’s DARZALEX, followed by CAR-T cell therapies such as J&J’s Carvykti and Gilead-Arcellx’s anito-cel[4].

Competitive Landscape

The multiple myeloma market is highly competitive, with several key players. Johnson & Johnson and Genmab are currently the leaders, with DARZALEX driving their dominance. However, other companies like Pfizer, Regeneron, Gilead, and Arcellx are expected to gain more market share in the future. Bristol Myers Squibb (BMS), which was once the largest player after acquiring Celgene, is seeing a decline due to the erosion of sales from its blockbuster drug Revlimid following the introduction of generic versions[1].

Impact of Generic Competition

The entry of generic versions of Revlimid has significantly impacted BMS’s revenue. Despite having potential successors in late-phase development, analysts predict that these new drugs will not recoup the sales lost to generics, even if they offer better safety and efficacy[1].

New Formulations and Therapies

The development of new formulations and therapies is crucial for maintaining market dominance. DARZALEX Faspro, the subcutaneous version of DARZALEX, has been a game-changer, allowing patients to receive doses in minutes rather than hours. This convenience has led to 85% of patients switching to Faspro[2].

CAR-T Cell Therapies and Bispecific Antibodies

In addition to DARZALEX, J&J is also leading in CAR-T cell therapies with Carvykti, which is expected to face competition from Gilead-Arcellx’s anito-cel starting in 2027. In the bispecific antibody space, J&J’s Tecvayli, developed in alliance with Genmab, is anticipated to remain the biggest seller despite challenges from Pfizer’s Elrexfio and Regeneron’s linvoseltamab[1].

Regulatory and Pricing Factors

The Inflation Reduction Act will impact the pricing of DARZALEX and its subcutaneous formulation starting in 2029. This could affect the revenue projections, although the overall market dominance of DARZALEX is expected to remain intact[4].

Patient Outcomes and Market Expansion

The innovations in multiple myeloma treatments, including DARZALEX, have significantly improved patient outcomes. Patients are now living more than 10 years, compared to 3.5 years in the late 1990s. This improvement has bolstered drug sales, with a further 40% increase expected by 2030[4].

Financial Guidance and Outlook

Genmab has updated its financial guidance for 2024, driven by higher royalty revenues from DARZALEX. The company expects revenue to range between DKK 21,100 million and DKK 21,700 million, with operating profit projected between DKK 6,200 million and DKK 7,100 million[5].

Key Takeaways

• Market Dominance: DARZALEX is expected to dominate the multiple myeloma market, with sales projected to reach $14.7 billion by 2030.
• Revenue Growth: The drug has shown consistent revenue growth, with a 19% increase in the first nine months of 2024 compared to the same period in 2023.
• Competitive Landscape: J&J and Genmab lead the market, but other companies are gaining ground.
• New Formulations: DARZALEX Faspro has significantly improved patient convenience and adoption.
• Regulatory Impact: The Inflation Reduction Act will affect pricing starting in 2029, but overall market dominance is expected to remain.
• Patient Outcomes: Innovations have improved patient survival rates, driving market expansion.

FAQs

Q: What is the current market performance of DARZALEX?

A: As of 2024, DARZALEX has shown strong sales performance, with net sales reaching $8.586 billion in the first nine months, a 19% increase from the same period in 2023.

Q: What are the projected sales of DARZALEX by 2030?

A: Bloomberg Intelligence predicts that DARZALEX sales will hit $14.7 billion by 2030.

Q: How does DARZALEX Faspro differ from the original DARZALEX?

A: DARZALEX Faspro is a subcutaneous formulation that allows patients to receive doses in minutes, compared to hours for the intravenous administration of the original DARZALEX.

Q: What impact will the Inflation Reduction Act have on DARZALEX pricing?

A: The Inflation Reduction Act will lead to Medicare-negotiated pricing for DARZALEX starting in 2029, which may affect revenue projections.

Q: Which companies are expected to challenge J&J’s dominance in the multiple myeloma market?

A: Companies like Pfizer, Regeneron, Gilead, and Arcellx are expected to gain more market share in the future.

Cited Sources

1. FiercePharma: Analysts predict myeloma market will hit $33B by 2030[1].
2. FiercePharma: Johnson & Johnson's Darzalex continues its upward trajectory[2].
3. FutureWise Research: Daratumumab Market By Drug Type, By Application, By Distribution[3].
4. Manufacturing Chemist: Factors driving the expansion of the multiple myeloma drug market[4].
5. GlobeNewswire: Genmab Announces Financial Results for the First Nine Months of 2024[5].

Last updated: 2024-12-16