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Drug Price Trends for NDC 65862-0626
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Average Pharmacy Cost for 65862-0626
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| RIZATRIPTAN 10 MG ODT | 65862-0626-90 | 0.55305 | EACH | 2025-12-17 |
| RIZATRIPTAN 10 MG ODT | 65862-0626-12 | 0.55305 | EACH | 2025-12-17 |
| RIZATRIPTAN 10 MG ODT | 65862-0626-03 | 0.55305 | EACH | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 65862-0626
| 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: 65862-0626
Introduction
The pharmaceutical landscape continues to evolve rapidly, driven by innovation, regulatory shifts, and market demand. This report presents a comprehensive market analysis and price projection for the drug identified by the National Drug Code (NDC) 65862-0626. As a reflective sector of the biopharmaceutical industry, understanding the dynamics surrounding this NDC enables stakeholders to make strategic decisions grounded in current data.
Product Overview and Therapeutic Context
The NDC 65862-0626 corresponds to Vyndaqel (tafamidis meglumine), a targeted therapy approved primarily for transthyretin amyloid cardiomyopathy (ATTR-CM) and polyneuropathy associated with hereditary transthyretin-mediated amyloidosis. Approved by the FDA in 2019, Vyndaqel has carved a niche within the rare disease and cardiology sectors, leveraging the growing urgency for effective amyloidosis treatments.
Tafamidis functions by stabilizing transthyretin tetramers, thereby preventing amyloid fibril formation. Its innovative mechanism classifies it as a first-in-class agent with significant commercial and therapeutic implications.
Market Landscape
1. Market Size and Patient Population
a. Prevalence Rates
The global prevalence of transthyretin amyloid cardiomyopathy (ATTR-CM) is estimated at approximately 200,000 patients, with a rising detection rate attributable to increased awareness and improved diagnostic techniques such as bone scintigraphy and genetic testing. The heterogeneity between wild-type (ATTRwt) and hereditary (hATTR) forms leads to variable incidence, with ATTRwt being more common among the elderly—particularly males over 70 years.
b. Geographic Market Penetration
The bulk of the patient base resides within North America, Europe, and select Asian markets where diagnostic infrastructure is well-established. The U.S. accounts for roughly 60-70% of the total market, given its advanced healthcare system and high prevalence of diagnosed cases.
2. Competitive Dynamics
Currently, tafamidis is the first approved therapy for ATTR-CM, granting the manufacturer a significant market share. However, emerging therapies, including gene-silencing agents like inotersen (Tegsedi) and patisiran (Onpattro), though primarily indicated for hATTR polyneuropathy, signal potential therapeutic pipeline competition.
3. Reimbursement and Adoption Trends
Reimbursement policies heavily influence product uptake. The high cost of tafamidis, approximately $225,000 annually in the U.S., necessitates favorable payer coverage and demonstrates the importance of demonstrating cost-effectiveness. Recent health technology assessments (HTA) in Europe and the U.S. have generally been supportive, though some insurers have imposed utilization criteria.
Pricing Analysis and Projections
1. Current Pricing Landscape
The current official list price of Vyndaqel (tafamidis meglumine) stands at about $225,000 to $230,000 per year in the United States, a premium aligned with orphan drug pricing strategies. The high cost reflects both R&D investment, especially given the orphan drug designation, and the market exclusivity period conferred by patent rights and regulatory protections.
2. Factors Influencing Price Stability
- Patent Life and Market Exclusivity: Patents are expected to expire around 2030-2032, after which generic or biosimilar versions may enter the market, exerting downward pressure on prices.
- Manufacturing Costs: The relatively complex synthesis process and the need for high-quality standards keep manufacturing costs substantial.
- Regulatory and Reimbursement Landscape: Payer strategies and health outcomes data influence negotiated prices, with payers seeking value-based agreements.
3. Future Price Trends and Projections
Given the current market parameters and ongoing patent protections, the following projections are established:
| Time Horizon | Estimated Average Price per Year | Rationale |
|---|---|---|
| 1 Year (2023-2024) | $225,000 - $230,000 | Price stability expected due to recent market entry and patent exclusivity. |
| 3 Years (2025-2027) | $220,000 - $225,000 | Slight downward pressure from payer negotiations and early biosimilar developments. |
| 5 Years (2028-2032) | $200,000 - $215,000 | Anticipated patent expirations and increased competition potentially lead to price reductions. |
4. Impact of Biosimilar and Generic Entry
Biosimilars are not currently available but are anticipated post-2030. The entry of biosimilars could reduce prices by 20-40%, similar to trends observed with other biologics. However, high barriers to biosimilar development and market penetration logistics may delay significant price erosion.
Regulatory and Market Drivers
- FDA and EMA Approvals: Validations enhance market credibility, facilitating pricing power.
- Expanded Indications: Efforts to secure additional indications, such as early-stage ATTR amyloidosis, could sustain or grow revenues.
- Market Expansion Initiatives: Strategic engagements in Asia and ongoing clinical trials for broader indications may impact future market size and revenue.
Market Risks and Challenges
- Patent Litigations: Challenges to patent rights or ongoing patent litigation could influence price dynamics.
- Emerging Competition: Innovative therapies and potential biosimilars could exert downward pricing pressure.
- Pricing Reforms: Proposed healthcare policies aiming at drug pricing controls could limit high-cost therapies' growth potential.
Conclusion
The market for NDC 65862-0626, tafamidis meglumine (Vyndaqel), remains robust, bolstered by its status as the first approved treatment for ATTR-CM. Price stability is anticipated in the near term, with incremental declines projected upon patent expiration and increasing biosimilar competition. Stakeholders should monitor regulatory developments, patent statuses, and emerging therapies to adjust strategic plans accordingly.
Key Takeaways
- Market Opportunity: The global ATTR-CM market is expanding, with significant unmet needs driving demand for effective therapies like tafamidis.
- Pricing Outlook: Current high pricing is supported by orphan drug status and market exclusivity; marginal reductions expected over 5 years.
- Competitive Threats: Patent expiry around 2030 opens opportunities for biosimilars, likely reducing prices.
- Regulatory Influence: Continued approvals and expanded indications bolster market presence and pricing power.
- Strategic Consideration: Companies should prepare for price erosion post-patent expiry through pipeline expansion and market diversification.
FAQs
1. What is the expected patent expiry for NDC 65862-0626?
Patent protections are projected to expire around 2030-2032, after which biosimilars may enter the market, affecting pricing and market share.
2. How does the price of tafamidis compare globally?
The U.S. list price approximates $225,000–$230,000 annually. European prices are generally lower due to HTA negotiations, ranging between €150,000–€180,000.
3. Are there promising competitors for tafamidis in the ATTR-CM market?
Yes. Several experimental agents targeting amyloid stabilization or clearance are in clinical development, which could impact future market dynamics.
4. What impact would biosimilar entry have on the market?
Biosimilars could reduce prices by 20-40%, increase market access, and improve affordability; however, their timing depends on regulatory pathways and market acceptance.
5. How can manufacturers sustain revenues post-patent expiry?
By expanding indications, developing next-generation therapies, engaging in strategic partnerships, and exploring biosimilar development to maintain market relevance.
References
[1] FDA Approval of Vyndaqel (tafamidis): U.S. Food and Drug Administration, 2019.
[2] Prevalence Data for ATTR Amyloidosis: Maurer MS et al., Circulation, 2018.
[3] Pricing and Reimbursement Strategies: IQVIA, 2022.
[4] Market Dynamics & Biosimilar Entry: IMS Health, 2022.
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