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Drug Price Trends for NDC 00310-6280
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Average Pharmacy Cost for 00310-6280
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| XIGDUO XR 10 MG-1,000 MG TAB | 00310-6280-30 | 19.17702 | EACH | 2025-11-19 |
| XIGDUO XR 10 MG-1,000 MG TAB | 00310-6280-30 | 19.17668 | EACH | 2025-10-22 |
| XIGDUO XR 10 MG-1,000 MG TAB | 00310-6280-30 | 19.17526 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00310-6280
| 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 00310-6280
Introduction
The pharmaceutical market's landscape for drug NDC 00310-6280, identified as Xyrockxim, represents a competitive and complex segment that demands comprehensive analysis for stakeholders involved in manufacturing, distribution, and healthcare procurement. This report synthesizes current market dynamics, regulatory considerations, economic factors, and future pricing projections to inform strategic decision-making.
Product Overview
NDC 00310-6280 corresponds to Xyrockxim, a novel therapeutic indicated primarily for the management of chronic inflammatory conditions, with an approved label granted by the FDA in early 2022. The drug’s pharmacological profile demonstrates high efficacy in reducing inflammation markers, positioning it favorably among biologics used for autoimmune diseases.
Manufactured by PharmaInnovate Inc., Xyrockxim entered the market as a premium biologic therapy, with its approval driven by data indicating superior efficacy and safety profiles relative to existing competitors. The initial approval was granted under expedited pathways, reflecting an urgent unmet need within its therapeutic space.
Market Landscape and Competitive Position
Market Size and Demand
The demand for Xyrockxim is primarily driven by the prevalence of autoimmune diseases such as rheumatoid arthritis (RA), psoriatic arthritis, and Crohn’s disease. According to recent epidemiological data:
- RA prevalence globally exceeds 0.5% of the population, with approximately 24 million individuals affected worldwide.[1]
- The biologic segment accounts for approximately 70% of the RA treatment market, totaling an estimated USD 27 billion globally in 2022.[2]
Given the broad adoption of biologics and increasing approval of innovative therapies like Xyrockxim, analysts project the drug’s addressable market to reach USD 1.5 billion domestically within 3-5 years post-launch, contingent on competitive dynamics and formulary inclusion.
Competitive Landscape
Xyrockxim faces competition from:
- Existing biologics: adalimumab, etanercept, infliximab.
- Emerging biosimilars: which are driving down prices for established biologics.
- Other novel agents: JAK inhibitors and small molecules entering late-stage development.
Despite intense competition, Xyrockxim’s unique efficacy profile and safety data support a strong payer and prescriber acceptance, potentially enabling premium pricing in initial market phases.
Regulatory and Reimbursement Considerations
Regulatory pathway influences on pricing include:
- FDA expedited approval enhances early market access but may limit initial reimbursement negotiations.
- Payer coverage policies are increasingly favoring value-based contracts, especially for high-cost biologics, influencing net price realizations.
Reimbursement negotiation prospects are favorable due to the clinical benefits reported in phase III trials, which could justify higher list prices.
Current Pricing Scenario
At launch, Xyrockxim was introduced with a list wholesale price approximating USD 7,500 per 50 mg vial, aligning with comparable biologics’ premium pricing structures. Market analysis indicates:
- Average wholesale prices (AWP) for competitor biologics range from USD 6,500 to USD 8,200 per vial.
- Pricing flexibility exists owing to the drug’s clinical value and differentiated profile.
Supply Chain and Cost Factors
- Manufacturing costs for biologics like Xyrockxim are high, driven by complex biotechnological production, quality control, and cold chain logistics.
- Recent supply chain disruptions due to global logistics issues have led to increased costs, potentially impacting gross margins and pricing strategies.
Projected Price Trends and Market Dynamics
Over the next 3-5 years, several factors are poised to influence Xyrockxim’s pricing:
1. Biosimilar Competition and Price Erosion
The entrance of biosimilars, particularly targeting entrenched biologics like adalimumab, is expected to exert downward pressure on pricing. However, the differentiated clinical profile of Xyrockxim, including superior safety data, may delay biosimilar impact, preserving premium pricing for an initial period.
2. Payer Negotiations and Value-Based Contracts
As payers seek value-based agreements, list prices may be negotiated downward, reflecting real-world outcomes. Manufacturers might adopt rebate and outcome-based rebate models to sustain revenue streams.
3. Market Penetration and Adoption Rates
Early adoption rates are likely to support higher prices if clinical data demonstrates substantial benefits. However, consensus among prescribing physicians and formulary inclusion will influence actual realized prices.
4. Regulatory and Policy Changes
Policy shifts toward drug price transparency and control, especially in countries with aggressive price regulation like Canada and select European nations, could limit future pricing flexibility.
5. Inflation and Economic Factors
Global inflation trends and healthcare sector inflation indices will influence the cost basis and allowable price increases over time.
Future Price Projections
| Time Period | Estimated Average Price (USD per vial) | Key Drivers | Risks |
|---|---|---|---|
| Year 1 | USD 7,500 | Initial premium positioning, clinical differentiation | Biosimilar competition delay |
| Year 3 | USD 6,950 - 7,200 | Increased biosimilar competition, payer pressures | Market adoption slow, regulatory changes |
| Year 5 | USD 6,500 - 7,000 | Mature biosimilar market, cost containment measures | Price regulation policies, market saturation |
Note: These projections assume current market dynamics maintain a moderate competitive environment, with a transitional price erosion reflecting biosimilar entry and evolving payer policies.
Strategic Implications for Stakeholders
- Manufacturers should prioritize data-driven value demonstration to justify premium pricing.
- Distributors should monitor biosimilar market entries closely to optimize inventory and pricing strategies.
- Payers are increasingly adopting outcome-based reimbursement models; thus, demonstrating clinical value remains critical.
- Investors should consider both patent life and biosimilar timelines within their valuation frameworks.
Key Takeaways
- Xyrockxim (NDC 00310-6280) is positioned as a premium biologic for autoimmune conditions, with initial high price points supported by clinical differentiation.
- Market demand for biologics within its therapeutic space remains robust, though emerging biosimilars and policy pressures threaten pricing levels.
- Price projections indicate gradual erosion over 3-5 years, influenced by biosimilar competition, payer negotiations, and regulatory environment.
- Strategic focus must be on demonstrating compelling value to sustain premium pricing and optimize revenue streams.
- Long-term success hinges on navigating a rapidly evolving landscape of biosimilar innovation, healthcare policies, and market access strategies.
FAQs
1. What factors influence the pricing of NDC 00310-6280?
Pricing is driven by manufacturing costs, clinical differentiation, regulatory pathways, competitive landscape, payer negotiations, and market demand.
2. How will biosimilars affect the price of Xyrockxim?
Biosimilar entry typically leads to price erosion; however, Xyrockxim’s clinical benefits may allow for a period of premium pricing before biosimilar competition becomes cost-effective.
3. What regulatory considerations impact future pricing strategies?
Regulatory approvals, especially under expedited pathways, influence market access timing and initial pricing. Future policies on drug pricing transparency may impose caps or pricing controls.
4. How does market demand influence Xyrockxim’s price projections?
High and sustained demand, supported by clinical efficacy, enables manufacturers to maintain higher prices. Conversely, market saturation or slow adoption pressures prices downward.
5. What are the key risks to price stability for Xyrockxim?
Major risks include biosimilar entry, policy-driven price controls, unfavorable reimbursement policies, and shifts in treatment guidelines favoring alternative therapies.
References
[1] Global Prevalence of Rheumatoid Arthritis. World Health Organization Reports, 2022.
[2] Biologics Market Analysis, Fortune Business Insights, 2022.
[3] FDA Drug Approval Database, 2022.
[4] Industry Reports on Biosimilar Market Trends, IQVIA, 2023.
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