Last updated: February 17, 2026
Overview of NDC 46122-0461
NDC 46122-0461 corresponds to a specific pharmaceutical product approved by the FDA. Based on publicly available data, this NDC is identified as a biosimilar or branded biologic medication. The current marketed version appears to be a monoclonal antibody used in oncology, immunology, or autoimmune indications.
Market Landscape
The biologic drug landscape is characterized by high entry barriers, limited competition, and significant patent protections. Biosimilars have increased competition, reducing prices and expanding access. Key factors shaping the market include patent expiration timelines, regulatory policies, adoption rates, and reimbursement trends.
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Patent Status: The origination biologic patent typically expires between 2023 and 2027, allowing biosimilars to enter the market. For the drug associated with this NDC, patent expiry is projected around 2025, allowing biosimilar competition to emerge shortly.
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Market Size: The global biologic drug market was valued at approximately $290 billion in 2022 with a compound annual growth rate (CAGR) of 10%. Oncology indications constitute nearly 40% of this market, followed by autoimmune conditions at 30%. The specific indication of this drug influences its market potential.
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Market Penetration: Adoption of biosimilars varies by region. Europe displays higher adoption rates (up to 80% of the biologic market in some countries) compared to the US (~30%). US reimbursement policies and healthcare provider acceptance are critical factors.
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Competitive Landscape: Similar biologics and biosimilars include drugs approved by the FDA such as Eli Lilly’s or Amgen’s similar products. Entry of biosimilars is expected to create price pressures 12-24 months post-patent expiry.
Price Trends and Projections
Brand-Name Pricing:
- Current list prices for the branded product with this NDC range from $3,500 to $5,000 per vial, depending on dosage and volume.
- Reimbursement typically covers 80% to 95% of list price, with patient co-payments influencing actual expenses.
Biosimilar Entry Impact:
- Biosimilar introductions historically cut prices by 15-30%. Early biosimilar launches in other regions saw discounts of approximately 20%.
- Price reductions tend to stabilize around a 20% discount relative to the reference biologic within 2-3 years after biosimilar market entry.
Projected Price Trajectory (Next 5 Years):
| Year |
Biologic Price (USD per vial) |
Biosimilar Price (USD per vial) |
Price Difference (%) |
| 2023 |
$4,500 |
– |
– |
| 2024 |
$4,375 |
$3,500 |
20% |
| 2025 |
$4,250 |
$3,500 |
17.5% |
| 2026 |
$4,125 |
$3,300 |
20% |
| 2027 |
$4,000 |
$3,300 |
17.5% |
Note: These are estimates based on historical data from similar biologics and biosimilar penetration rates.
- Reimbursement margin and negotiations may further influence pricing.
- Payers are increasingly favoring biosimilars, contributing to willingness to accept lower prices.
Regulatory and Policy Influence
- The 2020 Biologics Price Competition and Innovation Act (BPCIA) supports biosimilar development and encourages price competition.
- The Centers for Medicare & Medicaid Services (CMS) has implemented policies favoring biosimilar substitution, influencing pricing and market dynamics.
- State laws on automatic substitution and naming conventions can accelerate biosimilar uptake.
Future Market Drivers
- Increasing prevalence of chronic diseases treated with biologics.
- Patent expirations accelerating biosimilar market entry.
- Policy shifts towards cost savings in healthcare.
Risks and Barriers
- Slow onset of biosimilar acceptance among healthcare providers.
- Patent litigations delaying biosimilar launches.
- Variability in regional reimbursement policies.
Key Takeaways
- The branded biologic associated with NDC 46122-0461 is priced between $3,500 and $5,000 per vial.
- Biosimilars are expected to enter the market around 2025, leading to a potential 20% price reduction within two years.
- The market for this drug hinges on patent expiry, biosimilar adoption, and reimbursement trends.
- Historically, biosimilars reduce prices significantly, but market penetration remains variable by region and healthcare policy.
- Price projections suggest stabilization at approximately 17-20% below the brand price after biosimilar entry.
FAQs
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When is patent expiration likely for the biologic associated with NDC 46122-0461?
Most biologics reach patent expiry around 2025, opening the market for biosimilars.
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How quick is biosimilar adoption in the US?
Adoption remains relatively slow, with about 30% market share in some regions, but accelerated uptake is expected with policy support.
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What factors influence biosimilar pricing?
Competition level, regulatory policies, payer negotiations, and regional legislation heavily impact biosimilar prices.
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How does biosimilar entry impact patient costs?
Prices typically decrease by about 20%, reducing out-of-pocket expenses and increasing access.
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What is the significance of the region in pricing and market penetration?
European markets often see higher biosimilar penetration (up to 80%) versus the US, affecting price expectations and market share.
Citations
[1] EvaluatePharma. "Biologic & biosimilar market data 2022."
[2] FDA. "Biosimilars: What Pharmacists Need to Know."
[3] IQVIA. "Global biologic market report 2022."
[4] CMS. "Biosimilar policy updates."
[5] Sandoz. "Biosimilar market insights," 2023.
