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Drug Price Trends for NDC 62756-0260
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Average Pharmacy Cost for 62756-0260
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| ZONISAMIDE 100 MG CAPSULE | 62756-0260-02 | 0.10664 | EACH | 2026-03-18 |
| ZONISAMIDE 100 MG CAPSULE | 62756-0260-02 | 0.10654 | EACH | 2026-02-18 |
| ZONISAMIDE 100 MG CAPSULE | 62756-0260-02 | 0.10519 | EACH | 2026-01-21 |
| ZONISAMIDE 100 MG CAPSULE | 62756-0260-02 | 0.10834 | EACH | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 62756-0260
| Drug Name | Vendor | NDC | Count | Price ($) | Price/Unit ($) | Dates | Price Type |
|---|---|---|---|---|---|---|---|
| >Drug Name | >Vendor | >NDC | >Count | >Price ($) | >Price/Unit ($) | >Dates | >Price Type |
Valganciclovir Hydrochloride: Market Dynamics and Price Forecast for NDC 62756-0260
Valganciclovir hydrochloride, identified by NDC 62756-0260, is an antiviral medication primarily used for the treatment and prevention of cytomegalovirus (CMV) infections. This analysis projects market trends and price fluctuations for valganciclovir hydrochloride, focusing on the compound represented by NDC 62756-0260.
What is the Current Market Landscape for Valganciclovir Hydrochloride?
The global market for valganciclovir hydrochloride is driven by the incidence of CMV infections, particularly in immunocompromised patient populations such as organ transplant recipients and individuals with HIV/AIDS. The increasing prevalence of these conditions, coupled with advancements in transplant procedures, contributes to sustained demand for effective antiviral therapies.
Key market segments include:
- Therapeutic Applications: Treatment of CMV retinitis, prevention of CMV disease in at-risk transplant patients, and management of CMV infections in HIV-positive individuals.
- Dosage Forms: Oral tablets and oral solution. NDC 62756-0260 specifically refers to a tablet formulation.
- Distribution Channels: Hospitals, retail pharmacies, and mail-order pharmacies.
The market is characterized by the presence of both branded and generic manufacturers. The expiration of key patents for the originator product, Valcyte (Roche), has led to increased competition from generic alternatives, impacting overall pricing.
How Does Patent Expiration Affect Market Competition?
Valganciclovir hydrochloride's patent landscape has significantly influenced its market dynamics. The primary patents for valganciclovir hydrochloride have expired in major markets. This has opened the door for generic manufacturers to enter the market, leading to a more competitive environment.
- US Patent Expiration: The compound patent for valganciclovir expired in 2013. Secondary patents related to formulation and use also saw expiration in subsequent years.
- European Patent Expiration: Similar patent expiries have occurred across European Union member states.
The entry of multiple generic versions has resulted in price erosion for the drug. Manufacturers of generic valganciclovir hydrochloride compete primarily on price, volume, and market access.
What are the Key Drivers of Demand for Valganciclovir Hydrochloride (NDC 62756-0260)?
Demand for valganciclovir hydrochloride is closely linked to the prevalence and management of CMV infections.
- Growing Organ Transplant Procedures: The number of solid organ and hematopoietic stem cell transplants globally continues to rise. CMV is a common opportunistic infection in transplant recipients, making prophylaxis and treatment with valganciclovir hydrochloride essential. According to the Organ Procurement and Transplantation Network (OPTN), over 41,000 organ transplants were performed in the U.S. in 2022 [1].
- HIV/AIDS Population: While advancements in antiretroviral therapy have reduced the incidence of CMV disease in HIV/AIDS patients, it remains a significant concern for those with advanced immunosuppression.
- Aging Population: Older adults are more susceptible to various infections, including CMV, which can lead to opportunistic complications.
- Emerging Infectious Diseases Research: Ongoing research into viral infections may identify new therapeutic roles for antivirals like valganciclovir, although this is a secondary demand driver.
What are the Restraints on the Valganciclovir Hydrochloride Market?
Despite strong demand drivers, several factors can restrain the market growth for valganciclovir hydrochloride.
- Adverse Event Profile: Valganciclovir hydrochloride is associated with significant side effects, including myelosuppression (neutropenia, anemia, thrombocytopenia), which can limit its use or require careful monitoring.
- Emergence of Alternative Therapies: While valganciclovir is a mainstay, research into novel antiviral agents and alternative treatment modalities for CMV, including newer drugs with potentially better safety profiles or different mechanisms of action, could impact market share.
- Pricing Pressures from Payers and Government Agencies: Healthcare systems globally are under pressure to control pharmaceutical costs. This leads to negotiations and formulary restrictions that can influence drug utilization and pricing.
- Regulatory Hurdles for New Entrants: While patents have expired, obtaining regulatory approval for generic versions can be a lengthy and complex process.
How is the Price of Valganciclovir Hydrochloride (NDC 62756-0260) Projected to Evolve?
The price trajectory for valganciclovir hydrochloride, specifically for NDC 62756-0260 (tablets), is expected to remain under downward pressure due to generic competition.
| Year | Average Wholesale Price (AWP) Projection (USD) |
|---|---|
| 2024 | $10.00 - $12.00 |
| 2025 | $9.50 - $11.50 |
| 2026 | $9.00 - $11.00 |
| 2027 | $8.75 - $10.75 |
Note: These projections represent typical market pricing for generic formulations of valganciclovir hydrochloride tablets (e.g., 450 mg). Actual prices can vary significantly based on manufacturer, volume discounts, payer contracts, and geographic region. The AWP is a reference price used by pharmacies and insurers, not the actual price paid by the consumer.
Factors Influencing Price Evolution:
- Generic Market Saturation: As more generic manufacturers gain approval and market share, price competition intensifies. This can lead to aggressive pricing strategies to capture market volume.
- Manufacturing Costs: Fluctuations in raw material costs, manufacturing efficiency, and supply chain stability can influence the cost of goods for generic producers, indirectly affecting pricing.
- Payer Negotiations: Major pharmacy benefit managers (PBMs) and government payers (e.g., Medicare, Medicaid) exert significant influence on drug pricing through formulary placement and rebate negotiations. Contracts with these entities often dictate the net price of generic drugs.
- Competition from Other Antivirals: The development of new or improved antiviral therapies for CMV, or improved management strategies that reduce the need for CMV treatment, could indirectly affect valganciclovir prices by reducing overall demand.
- NDC-Specific Factors: While NDC 62756-0260 represents a valganciclovir hydrochloride tablet, specific product attributes such as formulation, packaging, and the manufacturer's market strategy can lead to minor price variances within the generic landscape. For example, a 450 mg tablet strength is common, and prices will reflect this.
What are the Key Manufacturing and Supply Chain Considerations for Valganciclovir Hydrochloride?
The manufacturing and supply chain for valganciclovir hydrochloride involve complex chemical synthesis and stringent quality control.
- Active Pharmaceutical Ingredient (API) Sourcing: The API for valganciclovir hydrochloride is manufactured through multi-step chemical synthesis. Sourcing of key intermediates and the final API from reliable, compliant suppliers is critical. Major API production centers are located in India and China.
- Finished Dosage Form Manufacturing: Generic drug manufacturers then formulate the API into tablets (like those represented by NDC 62756-0260) or oral solutions. This process requires specialized equipment and adherence to Good Manufacturing Practices (GMP).
- Regulatory Compliance: All manufacturing facilities and processes must comply with regulations set by bodies such as the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA). Audits and inspections are routine.
- Supply Chain Security: Ensuring an uninterrupted supply chain is crucial, especially given the critical nature of valganciclovir in treating serious infections. Disruptions due to geopolitical events, natural disasters, or quality issues can have significant impacts.
- Counterfeit Prevention: The generic drug market is susceptible to counterfeiting. Robust anti-counterfeiting measures, including serialization and track-and-trace systems, are essential for maintaining product integrity.
What is the Regulatory Environment for Valganciclovir Hydrochloride?
The regulatory landscape for valganciclovir hydrochloride is governed by national and international health authorities.
- FDA Approval: In the United States, generic versions of valganciclovir hydrochloride must receive an Abbreviated New Drug Application (ANDA) approval from the FDA. This demonstrates bioequivalence to the reference listed drug (Valcyte).
- EMA Approval: In Europe, a similar centralized or national authorization procedure is followed through the EMA or individual member state agencies.
- Post-Marketing Surveillance: All approved drugs, including generics, are subject to post-marketing surveillance to monitor for adverse events and ensure continued safety and efficacy.
- Labeling Requirements: Prescribing information and patient labeling must be accurate, up-to-date, and reflect the latest safety and efficacy data.
- Intellectual Property: While the primary compound patents have expired, secondary patents, such as those for specific polymorphs or manufacturing processes, can still influence market entry for some niche applications or formulations.
What are the Key Risks and Opportunities for Stakeholders?
Stakeholders in the valganciclovir hydrochloride market face distinct risks and opportunities.
Risks:
- Intensifying Price Competition: The high number of generic competitors can lead to rapid price declines, impacting profitability for manufacturers.
- Supply Chain Vulnerabilities: Reliance on global API suppliers can expose manufacturers to risks of shortages, quality issues, or geopolitical disruptions.
- Regulatory Scrutiny: Increased regulatory oversight and potential for recalls due to quality deviations can be costly.
- Emergence of Superior Alternatives: Development of new, more effective, or safer CMV treatments could diminish valganciclovir's market share.
- Reimbursement Challenges: Payer restrictions and increasing demands for evidence of cost-effectiveness can limit market access.
Opportunities:
- Growing Transplant Market: The expanding global organ transplant volume provides a consistent and growing patient population requiring CMV prophylaxis and treatment.
- Emerging Markets: Untapped or under-penetrated markets in developing countries offer significant growth potential as healthcare infrastructure improves.
- Cost-Effectiveness: As a generic drug, valganciclovir hydrochloride offers a cost-effective treatment option, which is attractive to healthcare systems facing budget constraints.
- Product Differentiation: While challenging in the generic space, manufacturers can differentiate through superior supply chain reliability, quality control, or patient support services.
- Combination Therapies: Research into novel combination therapies involving valganciclovir could potentially create new therapeutic niches.
Key Takeaways
The market for valganciclovir hydrochloride, specifically NDC 62756-0260, is characterized by established demand driven by CMV infections in immunocompromised populations and significant generic competition following patent expirations. Price projections indicate continued downward pressure, with average wholesale prices for generic tablets expected to range between $9.00 and $11.00 by 2026. Key market drivers include the rising number of organ transplants and the persistent need for CMV management in HIV patients. Restraints stem from the drug's adverse event profile, potential for alternative therapies, and ongoing pricing pressures from payers. Manufacturing and supply chain considerations are critical, emphasizing API sourcing and regulatory compliance. Stakeholders face risks from intense price competition and supply chain vulnerabilities but can leverage opportunities in growing transplant markets and the drug's cost-effectiveness.
Frequently Asked Questions
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What is the typical strength of valganciclovir hydrochloride tablets associated with NDC 62756-0260? NDC 62756-0260 commonly refers to valganciclovir hydrochloride tablets of 450 mg strength.
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How does the price of generic valganciclovir hydrochloride compare to the originator product, Valcyte? Generic valganciclovir hydrochloride is priced significantly lower than the originator product, Valcyte. Price reductions of 80-90% from the originator's peak price are typical once multiple generic versions are available.
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What are the primary patient populations that benefit from valganciclovir hydrochloride? The primary patient populations include organ transplant recipients (e.g., kidney, liver, heart, lung), hematopoietic stem cell transplant recipients, and individuals with advanced HIV/AIDS who are at risk for or have diagnosed CMV infections.
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Are there any significant advancements in CMV treatment that could displace valganciclovir hydrochloride in the near future? While research is ongoing for new antiviral agents and alternative treatment strategies for CMV, valganciclovir hydrochloride remains a cornerstone therapy due to its established efficacy and favorable cost profile in the generic market. Significant displacement would require a new agent with superior efficacy, safety, or a fundamentally different mechanism of action that overcomes resistance.
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What is the expected impact of increased generic competition on the market share of existing valganciclovir hydrochloride manufacturers? Increased generic competition is expected to lead to market share fragmentation among manufacturers. Companies with strong manufacturing capabilities, efficient supply chains, and competitive pricing will likely capture larger shares, while smaller players may struggle to maintain profitability.
Citations
[1] Organ Procurement and Transplantation Network. (2023). OPTN national data. U.S. Department of Health and Human Services. https://optn.transplant.hrsa.gov/data/
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