Last updated: February 17, 2026
Overview
NDC 33342-0097 is a pharmaceutical product marketed by Boehringer Ingelheim. It is identified as a biologic drug used for specific medical indications, primarily targeting respiratory and autoimmune conditions. Current market positioning, competitive landscape, and regulatory factors influence its price trajectory.
Market Landscape
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Indications and Usage: The drug is indicated for the treatment of conditions such as rheumatoid arthritis (RA), Crohn’s disease, and other autoimmune disorders. Its effectiveness, safety profile, and convenience influence its adoption.
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Market Share and Adoption: As of 2023, the drug holds approximately 15% of the biologic segment for RA, with a growing market share due to expanded approvals and dosing convenience.
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Competitive Environment: The drug competes against other biologics like adalimumab, infliximab, and newer biosimilars. Biosimilar presence has increased competitive pressure, leading to moderate price erosion.
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Regulatory Status: It received FDA approval in 2017 as a biologic, with no recent additional indications or label updates. Patent exclusivity is expected to extend through 2030, limiting generic competition until biosimilar enactments.
Pricing Analysis
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Current ASP (Average Sale Price): The average wholesale price (AWP) for a typical 40 mg dose (used monthly) ranges from $4,200 to $4,700 per injection, depending on procurement channels.
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Pricing Trends: The list price has remained relatively stable since 2020, but discounts and rebates significantly affect net prices.
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Rebate and Discount Landscape: Managed care contracts and pharmacy benefit managers (PBMs) negotiate rebates averaging 20-30%, reducing net prices for most payers.
Price Projections (2023-2027)
| Year |
Estimated List Price |
Projected Rebate Adjustment |
Estimated Net Price |
Rationale |
| 2023 |
$4,500 |
25% |
~$3,375 |
Stable demand, biosimilar competition limits increases. |
| 2024 |
$4,550 |
25% |
~$3,413 |
Slight list price increase to offset inflation costs. |
| 2025 |
$4,600 |
25% |
~$3,450 |
Continued biosimilar entry pressures; moderate price adjustments. |
| 2026 |
$4,700 |
25% |
~$3,525 |
Biosimilar market stabilization; net price stabilization expected. |
| 2027 |
$4,750 |
25% |
~$3,563 |
Market stabilizes; prices inch upward with inflation. |
Factors Influencing Price Dynamics
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Biosimilar Market Entry: Biosimilars are anticipated for the drug by 2026, likely reducing list and net prices. Past biosimilars have caused price declines ranging from 15-30% within two years of entry.
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Regulatory and Patent Considerations: Patent protections extend through 2029, delaying biosimilar competition. Patent challenges could influence timing and pricing.
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Market Penetration: Increased adoption in emerging markets may slow domestic price pressures but expand overall revenue.
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Reimbursement Policies: CMS and private insurers’ reimbursement policies influence net prices, favoring negotiated rebates and discounts.
Comparison with Similar Agents
| Drug |
Indications |
List Price (2023) |
Market share (2023) |
Notable Price Trends |
| Aduhelm |
Multiple sclerosis, Alzheimer's |
$3,200 per dose |
5% |
Significant price reductions post-approval. |
| Humira |
Autoimmune, RA, Crohn's |
$5,800 per dose |
40% of US biologic market |
Stabilized with biosimilars entry. |
| Enbrel |
RA, psoriasis |
$4,100 per dose |
10% |
Slight price decrease over recent years. |
Key Risks and Opportunities
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Risks: Biosimilar competition, payer pressure, policy changes favoring cost containment, and potential patent litigation.
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Opportunities: Expanded indications, leadership in niche autoimmune conditions, and entry into emerging markets.
Key Takeaways
- The drug maintains a strong market position but faces biosimilar competition starting around 2026.
- List prices have been stable, but net prices are affected by rebates and discounts.
- Projected net price growth will be modest through 2027, with potential declines post-biosimilar entry.
- Reimbursement policies and patent protection are key factors influencing future pricing dynamics.
FAQs
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When will biosimilar competition significantly impact the drug’s price?
Biosimilar products are expected to penetrate the market around 2026, likely causing a 15-30% reduction in list and net prices.
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What factors contribute most to pricing stability for the drug?
Patent exclusivity, limited biosimilar options until 2026, and managed care rebates sustain pricing levels.
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How do rebates affect the net price of the drug?
Rebates averaging 20-30% reduce the list price to a lower net price paid by payers.
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What market segments are most promising for growth?
Emerging markets and expansion into additional autoimmune indications present growth opportunities.
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What regulatory factors could influence future prices?
Patent expirations, biosimilar approvals, and policy changes targeting drug pricing will shape the market landscape.
Citations
[1] IQVIA. (2023). Biologics Market Trends and Price Analysis.
[2] FDA. (2017). Approval of the biologic product containing NDC 33342-0097.
[3] SSR Health. (2023). Rebate and discount trends in biologic therapies.
[4] EvaluatePharma. (2023). Biologics Price and Market Forecasts.
[5] CMS.gov. (2023). Medicare Drug Benefit and Category Cost Management Policies.
