Last updated: August 5, 2025
Overview of NDC 73683-0101
The National Drug Code (NDC) 73683-0101 corresponds to Daratumumab (Darzalex), a monoclonal antibody developed by Janssen Pharmaceuticals for the treatment of multiple myeloma. Approved by the FDA in 2015, Daratumumab has rapidly emerged as a cornerstone therapy for relapsed/refractory multiple myeloma, due to its targeted mechanism of action against CD38-expressing myeloma cells.
Market Environment and Competitive Landscape
Market Size and Growth Dynamics
Multiple myeloma remains a significant oncologic challenge, with an estimated 34,000 new cases annually in the U.S. and a prevalence of approximately 125,000 patients. The introduction of Daratumumab has revolutionized the treatment paradigm of multiple myeloma, shifting reliance from traditional chemotherapy and immunomodulatory agents to targeted monoclonal antibody therapy.
The global multiple myeloma market was valued at approximately $16.7 billion in 2022, projected to grow at a CAGR of 8% from 2023 to 2030. The expansion is primarily driven by an increased diagnosis rate, advancements in treatment regimens, and the approval of novel monoclonal antibodies, including Daratumumab.
Key Competitors and Alternatives
Daratumumab faces competition from several agents:
- Elotuzumab (Empliciti): Another CD38-targeting monoclonal antibody.
- Isatuximab (Sarclisa): Approved by the FDA in 2020 as another anti-CD38 antibody.
- Bortezomib, Lenalidomide, Pomalidomide: Historically used agents with established efficacy.
- Emerging therapies: CAR T-cell therapies and bispecific antibodies like Teclistamab are entering clinical scenes, potentially impacting Daratumumab's market share.
Market Penetration and Adoption Trends
Since its approval, Daratumumab has demonstrated rapid adoption, especially in relapsed/refractory settings, due to superior efficacy and manageable safety profiles. Its incorporation into frontline combination regimens (e.g., Daratumumab with Bortezomib, Melphalan, and Prednisone—D-VMP) has further augmented its penetration. However, the emergence of biosimilar and alternative targeted agents could modestly temper growth rates over the next decade.
Pricing Landscape and Cost Dynamics
Current Pricing Metrics
According to the FDA’s standard NDC listings and publicly available drug pricing databases, the approximate wholesale acquisition cost (WAC) for Daratumumab (per 1,800 mg vial) approximates $6,000–$7,000. Treatment regimens typically involve multiple infusions over several cycles, escalating overall costs.
For example:
- Initial induction involves weekly infusions over a month, then bi-weekly and monthly maintenance, resulting in cumulative drug costs exceeding $70,000–$120,000 per patient annually in the U.S.
- These figures align with recent market surveys indicating an average treatment cost of ~$100,000 per patient per year.
Pricing Trends and Influencing Factors
- Patent Protections and Exclusivity: As a first-in-class monoclonal antibody, Daratumumab’s patent exclusivity has preserved premium pricing. However, biosimilar competition is anticipated post-2027, with potential to reduce prices by up to 30–50%.
- Reimbursement Policies: CMS and private insurers' evolving coverage policies influence net prices. Value-based arrangements or outcomes-based contracts are beginning to moderate costs.
- Market Dynamics: Introduction of combination therapies, ongoing clinical trials, and emerging biosimilars are expected to exert downward pressure on prices.
Regulatory and Patent Landscape
Daratumumab's patent estate extends until approximately 2027-2028, after which biosimilar entries are anticipated, likely transforming the market. Patent litigations and exclusivity extensions may influence timing but are unlikely to prevent biosimilar proliferation altogether.
Price Projection Scenarios (2023–2030)
Best-Case Scenario (Optimistic)
- Market growth: Continued rapid adoption with expanding use in frontline therapy.
- Pricing: Slight reductions (~10%) due to increased biosimilar competition.
- Annual Price: Remaining stable around $95,000–$105,000 per patient, with downward adjustments post-biosimilar introduction.
- Market share: Maintains high due to clinical efficacy and established safety profile.
Moderate Scenario
- Market growth: Steady, with some impact from emerging therapies.
- Pricing: Moderate decline (~20–30%) over the forecast period.
- Annual Price: Dropping gradually to $80,000–$90,000 per course.
- Market penetration: Slightly plateauing, with biosimilar competition gaining ground.
Pessimistic Scenario (Recession or Disruption)
- Market growth: Slower due to market saturation or significant competition.
- Pricing: Sharp declines (~50%) expected post-biosimilar entry.
- Annual Price: Falling below $70,000, coupled with reduced utilization.
- Key factors: Regulatory delays, patent litigation failures, or emergence of superior therapies.
Implications for Industry Stakeholders
- Pharmaceutical companies should prioritize flexible pricing strategies aligned with biosimilar developments.
- Investors need to monitor patent litigation outcomes and biosimilar registration timelines.
- Healthcare payers can leverage biosimilar competition to negotiate better net prices.
- Clinicians should stay updated on evolving treatment standards that could influence demand and pricing.
Key Takeaways
- Daratumumab remains a high-value, high-price therapy, foundational in multiple myeloma management.
- Market growth is driven by increasing prevalence and expanding indication base, with a projected CAGR of 8%.
- Current average annual treatment costs are approximately $100,000, with future reductions anticipated due to biosimilar competition.
- Patent expiration around 2027-2028 portends significant market shifts, potentially halving prices.
- Strategic planning around patent cliffs, biosimilar entry, and emerging therapies is critical for stakeholders.
FAQs
Q1: When are biosimilars for Daratumumab expected to enter the market?
A: Biosimilar Daratumumab products are anticipated around 2027-2028, following patent expiry and regulatory approval processes.
Q2: How does Daratumumab’s price compare globally?
A: U.S. prices (~$100,000/year) are higher than many other countries due to healthcare system structures, pricing regulations, and negotiated discounts.
Q3: What factors could accelerate price declines?
A: Patent challenges, accelerated biosimilar approvals, and increased payer negotiation power can hasten price reductions.
Q4: Are there emerging therapies that may replace Daratumumab?
A: Emerging treatments, such as BCMA-targeted CAR T-cell therapies and bispecific antibodies, may complement or replace Daratumumab in certain indications.
Q5: How is the current market impacted by the COVID-19 pandemic?
A: The pandemic has temporarily delayed some clinical trials and affected infusion services, potentially impacting access and utilization rates.
References
[1] FDA. Daratumumab (Darzalex) Highlights. (2022).
[2] MarketWatch. Multiple Myeloma Market Size & Forecast. (2023).
[3] IQVIA. Biosimilars & Oncology Drugs Report. (2022).
[4] Deloitte. Healthcare Pricing and Competition Trends. (2023).
[5] ClinicalTrials.gov. Ongoing Trials with Daratumumab and Biosimilars.
