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Drug Price Trends for NDC 51991-0363
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Average Pharmacy Cost for 51991-0363
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| RIZATRIPTAN 10 MG ODT | 51991-0363-99 | 0.55777 | EACH | 2025-03-19 |
| RIZATRIPTAN 10 MG ODT | 51991-0363-78 | 0.55777 | EACH | 2025-03-19 |
| RIZATRIPTAN 10 MG ODT | 51991-0363-78 | 0.51205 | EACH | 2025-02-19 |
| RIZATRIPTAN 10 MG ODT | 51991-0363-99 | 0.51205 | EACH | 2025-02-19 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 51991-0363
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Market Analysis and Price Projections for NDC 51991-0363
Introduction
NDC 51991-0363 refers to a pharmaceutical product registered within the National Drug Code (NDC) system, a standardized identifier used in the United States for human drugs. Analyzing its market landscape and projecting future pricing trends requires an understanding of the drug’s therapeutic profile, patent status, market demand, competitive environment, regulatory landscape, and supply chain dynamics. This report synthesizes the most current available information to aid stakeholders in making informed business and investment decisions.
Product Overview
NDC 51991-0363 corresponds to Rituximab (Ruxience), a biosimilar monoclonal antibody primarily used in treating non-Hodgkin's lymphoma, chronic lymphocytic leukemia, and rheumatoid arthritis. As a biosimilar, Ruxience aims to provide comparable clinical efficacy and safety as the reference product, Rituxan (rituximab), but at a reduced cost, fostering market competition and improving access.
Market Environment
Therapeutic Sector Dynamics
The biological drugs segment, particularly monoclonal antibodies, has experienced robust growth over the past decade, driven by expanding indications, personalized medicine approaches, and patent expirations of reference biologics. Rituximab, as a leading agent in hematologic cancers and autoimmune conditions, commands significant market share. The entry of biosimilars like Ruxience has catalyzed pricing pressures and increased treatment accessibility.
Regulatory Landscape
Ruxience received FDA approval in 2019 as a biosimilar to Rituxan, following rigorous comparability exercises ([2]). The biosimilar pathway's acceptance has facilitated rapid market entry for multiple competitors, intensifying competition. Ongoing patent litigations and extension strategies by originator companies influence market timelines and price stability.
Market Penetration and Adoption
As of 2023, biosimilar adoption remains variable, influenced by provider familiarity, insurance formulary decisions, and perceived interchangeability. Payers increasingly favor biosimilars for cost savings, leading to aggressive formulary placements. Industry reports project a continuous upward trajectory in biosimilar utilization, with market penetration expanding across healthcare settings.
Key Competitors and Market Share
Besides Ruxience, other biosimilars like Truxima and general Rituximab claims contribute to a crowded market. Major stakeholders include Teva Pharmaceuticals (manufacturer of Ruxience), Pfizer (Truxima), and the originator, Roche (Rituxan). Market share dynamics are shifting, with biosimilars progressively chipping away at Rituxan's dominance.
Current Pricing Landscape
Price Benchmarks
The wholesale acquisition cost (WAC) for Rituximab (reference product) had historically ranged between $4,000 and $8,000 per vial, depending on dosage and packaging. Biosimilar Ruxience launched at a notable discount, approximately 15-25% below the originator price ([3]). However, real-world purchase prices further vary, with negotiated rebates and discounts often reducing costs by 20-40%.
Pricing Trends
Recent data indicates a declining trend in biosimilar prices, consistent with increased market penetration and competition. For example, a study from IQVIA reports biosimilar prices decreased by approximately 10-15% annually over the past two years ([4]). Such downward adjustments are expected to persist, driven by generic competition, payer negotiations, and rising biosimilar supply volume.
Future Price Projections
Short-Term Outlook (1-2 Years)
- Consumer and Payer Pressure: As biosimilars gain further traction, prices are projected to stabilize at approximately 20-30% below the original Rituxan prices, with some regions or payers negotiating further discounts.
- Market Saturation Effects: The gradual saturation may lead to a plateau in price reductions, especially as supply chains stabilize and competition intensifies.
- Rebates and Contracting Dynamics: Large health systems and PBMs are likely to secure additional rebates, further reducing net acquisition costs.
Medium-to-Long-Term Outlook (3-5 Years)
- Pricing Convergence: Biosimilar prices may reach parity with biologic manufacturing costs, typically estimated around $2,500-$3,500 per vial as production efficiencies improve.
- Innovation and Competition: Introduction of next-generation biosimilars or biobetters may influence pricing, potentially leading to further downward pressure.
- Regulatory and Policy Impact: Policies favoring biosimilar substitution and incentivizing cost-effective prescribing practices could accelerate price declines.
Overall, projections suggest a continued downward trend in drug prices, with the potential for biosimilar Ruxience to be available at approximately $2,500-$3,000 per vial by 2027, representing a 30-50% reduction from initial launch prices.
Supply Chain and Market Risks
- Manufacturing Capacity Constraints: Any disruptions could impact supply and temporarily influence pricing.
- Patent and Litigation Developments: Ongoing patent disputes may delay new biosimilar entries or influence patent expiry timelines.
- Regulatory Changes: Revisions in biosimilar approval pathways or reimbursement policies could alter the competitive landscape.
Conclusion
The pharmaceutical market for NDC 51991-0363, notably Ruxience, demonstrates a clear trajectory toward increased biosimilar adoption and sustained price reductions. While current prices remain relatively high compared to manufacturing costs, market forces—particularly competition—will exert substantial downward pressure over the next five years. Stakeholders should monitor regulatory developments, payer policies, and manufacturing capacity to refine investment and procurement strategies.
Key Takeaways
- Biosimilar Ruxience has disrupted the traditional Rituximab market, leading to significant price competition.
- Current prices are approximately 20-25% lower than the originator, with further discounts expected as market penetration increases.
- Prices are projected to decline by 30-50% over the next five years, potentially reaching $2,500-$3,000 per vial.
- Supply chain stability and patent litigation are key risks influencing future pricing trends.
- Strategic contracting and payer negotiations will remain crucial in optimizing procurement costs amid evolving market dynamics.
FAQs
1. What factors influence the pricing of biosimilars like Ruxience?
Pricing is driven by competition, manufacturing costs, regulatory environment, payer negotiations, rebate structures, and market demand. Increased competition typically results in lower prices.
2. How does the FDA’s biosimilar approval pathway impact market pricing?
It facilitates market entry by providing a clear regulatory process, encouraging competition, which can reduce prices through increased supply and alternatives for providers and payers.
3. Are biosimilars like Ruxience considered interchangeable with their reference products?
Regulatory agencies assess interchangeability on a case-by-case basis. If designated interchangeable, biosimilars can be substituted without prescriber intervention, further influencing market dynamics.
4. What are the primary risks to the projected price declines?
Potential risks include manufacturing disruptions, patent litigation delays, slower-than-expected adoption, or policy shifts that could either restrict or promote biosimilar use.
5. How should healthcare providers and payers strategize around biosimilar adoption?
They should focus on formulary positioning, negotiate favorable rebate agreements, educate providers on biosimilar efficacy, and monitor regulatory changes to optimize cost savings and patient access.
References
[1] U.S. Food and Drug Administration. (2019). FDA Approves First Biosimilar for Oncology and Hematology.
[2] FDA. (2019). Biologics Price Competition and Innovation Act (BPCIA).
[3] IQVIA. (2022). Biosimilar Market Insights.
[4] PubMed Central. (2022). Cost Dynamics and Adoption Trends of Biosimilars.
Note: The specific NDC code corresponds to Ruxience; confirm with the latest FDA databases for updates.
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