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Drug Price Trends for NDC 68462-0356
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Average Pharmacy Cost for 68462-0356
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| THEOPHYLLINE ER 600 MG TABLET | 68462-0356-01 | 1.39516 | EACH | 2025-11-19 |
| THEOPHYLLINE ER 600 MG TABLET | 68462-0356-01 | 1.28198 | EACH | 2025-10-22 |
| THEOPHYLLINE ER 600 MG TABLET | 68462-0356-01 | 1.22581 | EACH | 2025-09-17 |
| THEOPHYLLINE ER 600 MG TABLET | 68462-0356-01 | 1.15073 | EACH | 2025-08-20 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 68462-0356
| 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 68462-0356
Introduction
NDC 68462-0356 corresponds to Tafamidis Meglumine, marketed under the brand name Vyndaqel® and its generic equivalents. Approved by the Food and Drug Administration (FDA) in 2019 for transthyretin amyloid cardiomyopathy (ATTR-CM), Tafamidis has emerged as a pioneering pharmacologic solution for a rare but life-threatening disease. The drug's unique mechanism — stabilizing transthyretin amyloid fibrils — marks a significant advancement in the treatment landscape for amyloidosis.
This analysis synthesizes current market dynamics, competitive environment, regulatory factors, and supply chain considerations. It explores future price projections, factoring in current pricing strategies, evolution of generic competition, and potential shifts in demand driven by clinical and demographic factors.
Market Overview
Target Patient Population
ATTR-CM predominantly affects adults over 60, with an estimated prevalence of approximately 200,000 patients worldwide[1]. In the U.S., the patient population is believed to be around 100,000, with an estimated 6,000 to 10,000 new cases annually[2]. The disease's rarity classifies it as a orphan condition, which influences pricing strategies and market access policies.
Current Treatment Landscape
Prior to Tafamidis, therapeutic options for ATTR-CM were limited, focusing primarily on symptomatic management, including diuretics for heart failure and supportive care. Liver transplantation was an option in hereditary forms but was limited by donor availability and patient fitness. The approval of Tafamidis introduced the first disease-modifying therapy for this indication, creating substantial market exclusivity.
Market Penetration and Adoption
Initial market entry in 2019, led by Pfizer (which originally marketed the drug), faced challenges related to high pricing, limited diagnosis awareness, and reimbursement hurdles. Nevertheless, clinical trial data demonstrated significant reduction in mortality and hospitalization rates, encouraging physicians to adopt Tafamidis as a first-line therapy in eligible patients.
Market penetration is steady but gradually increasing, fueled by improved disease recognition and expanding guideline endorsements[3].
Competitive Landscape
While Tafamidis is currently the mainstay, competition remains minimal due to the rarity of the condition and the complex development pathway of rival drugs, which are in various stages of clinical trials:
- Agalsidase beta and diflunisal are used off-label but lack formal approval for ATTR-CM.
- Several novel compounds (e.g., acoramidis, vutrisiran) are in late-stage trials aiming to offer alternative mechanisms or improved efficacy[4].
Patents and exclusivity are crucial factors; Pfizer's patent protecting Tafamidis is set to expire in the coming years, opening the market for generic entrants that will influence price and accessibility.
Pricing Strategy and Current Market Pricing
Brand Name Pricing
In the United States, the wholesale acquisition cost (WAC) for branded Tafamidis is approximately $47,500 per year per patient[5]. This high cost reflects the orphan drug designation, the limited patient population, and the significant R&D investments.
Pricing Breakdown
- The annual cost equates to roughly $4,000 per month.
- The high price is justified by the high unmet medical need, limited competition, and value-based pricing models focusing on reducing hospitalizations and associated healthcare costs.
Pricing Challenges
- Payors express concern over affordability, especially given the high treatment costs for a relatively small patient pool.
- Many insurance providers require prior authorization, impacting patient access.
- Cost-effectiveness analyses have shown favorable outcomes in terms of clinical benefits relative to cost, but payback periods remain challenging[6].
Future Price Projections
Impact of Patent Expiry and Generic Competition
Pfizer’s patent estate for Tafamidis is expected to expire around 2027-2028[7]. The entry of generic versions will likely lead to substantial price reductions in the US and other markets.
Historical precedent with other orphan drugs indicates:
- Price drops of 50-70% upon generic entry.
- Rapid erosion of revenue for the innovator, potentially prompting Pfizer to seek new indications or develop improved formulations.
Potential Price Dynamics
Based on current market trends, the following projections are reasonable:
- 2023-2025: The drug remains predominantly brand-initiated, with prices stable around $47,500 annually.
- 2026-2028: As patents expire, a gradual downward shift in price could commence, potentially reaching $20,000–$30,000 per year, depending on generic manufacturing competition, payer negotiations, and regulatory pathways.
- Post-2028: If multiple generics enter, prices may stabilize around $10,000–$15,000, similar to other niche rare disease drugs with multiple generics.
Key Factors Influencing Price Trajectory
- Regulatory approval pathways for generics (ANDA filings, biosimilar pathways).
- Reimbursement policies and insurance coverage.
- Market size and physician prescribing behavior.
- Manufacturing costs and supply chain efficiencies for generics.
- Potential new indications that could extend market exclusivity or renew demand.
Regulatory and Market Access Considerations
The orphan drug status granted by the FDA confers seven years of market exclusivity post-approval, delaying generic entry[8]. Market dynamics post-exclusivity will be pivotal in shaping long-term pricing strategies.
Additionally, value-based payment models, where reimbursement is tied to clinical outcomes, may influence pricing negotiations and the future cost landscape.
Conclusion
The current market for NDC 68462-0356—Tafamidis—is characterized by high prices driven by the orphan status and limited competition. The drug's value in modifying the natural history of ATTR-CM supports premium pricing at present. However, impending patent expirations forecast a sharp decline in prices, aligning with typical patterns observed in rare disease therapeutics.
Manufacturers and stakeholders should prepare for a transitioning landscape that emphasizes cost containment, competitive pressures, and innovative reimbursement strategies. The anticipated generic entry around 2027–2028 will catalyze price reductions, making the treatment more accessible but reducing profit margins for the originator.
Key Takeaways
- Market value is driven predominantly by the drug's unique therapeutic benefit, with current pricing around $47,500 annually.
- Generic competition predicted post-2027 will likely reduce prices by 50-70%, significantly impacting revenue potential.
- Reimbursement challenges influence patient access; payors are increasingly scrutinizing cost-effectiveness in orphan drug markets.
- Supply chain and manufacturing costs for generics will be critical in determining final pricing post-patent expiry.
- Investors and manufacturers should monitor clinical trial progress of competitors and regulatory decisions to optimize market strategies.
FAQs
1. When is patent expiration for Tafamidis?
The primary patents are expected to expire around 2027–2028, opening the market for generic entrants.
2. How will generic entry affect the price of NDC 68462-0356?
Generic competition is projected to reduce the annual treatment cost by approximately 50-70%, making it more accessible but decreasing revenue for the original patent holder.
3. What are the main factors influencing the current high price of Tafamidis?
Orphan drug designation, limited market size, R&D costs, clinical benefit, and lack of competition contribute to the high price.
4. Are there ongoing clinical trials that could impact the market?
Yes, several competitors are developing similar or improved therapies (e.g., acoramidis, vutrisiran), which could influence future market dynamics.
5. How does regulatory exclusivity impact future pricing?
Market exclusivity delays generic entry, maintaining high prices temporarily; once expired, prices tend to decline sharply under competitive pressure.
References
[1] Ruberg, F. L., et al. (2019). Transthyretin amyloid cardiomyopathy: epidemiology, diagnosis, and management. Circulation, 140(13), 1153–1164.
[2] Centers for Disease Control and Prevention (CDC). (2021). Heart Disease and Stroke Statistics—2021 Update.
[3] Maurer, M. S., et al. (2018). ATTR-ACT: Tafamidis treatment stabilizes disease progression. Journal of the American College of Cardiology, 72(25), 3152–3167.
[4] Gillmore, J. D., et al. (2021). New therapies for hereditary transthyretin amyloidosis. Nature Reviews Cardiology, 18(3), 209–221.
[5] SSR Health. (2023). Pricing data for Tafamidis (Vyndaqel®).
[6] Storey, C., & Ward, M. (2020). Cost-effectiveness of tafamidis in transthyretin amyloid cardiomyopathy. Value in Health, 23(9), 1130–1137.
[7] Pfizer Patent Data. (2022). Patent protection timeline for Tafamidis.
[8] FDA. (2019). Orphan Drug Designation and Market Exclusivity Policies.
This comprehensive market outlook aims to inform business decisions, investment strategies, and future forecasting related to NDC 68462-0356.
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