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Drug Price Trends for NDC 52536-0884
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Average Pharmacy Cost for 52536-0884
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| VERAPAMIL SR 240 MG CAPSULE | 52536-0884-01 | 2.71899 | EACH | 2026-03-18 |
| VERAPAMIL SR 240 MG CAPSULE | 52536-0884-01 | 2.44906 | EACH | 2026-02-18 |
| VERAPAMIL SR 240 MG CAPSULE | 52536-0884-01 | 2.22765 | EACH | 2026-01-21 |
| VERAPAMIL SR 240 MG CAPSULE | 52536-0884-01 | 1.92525 | EACH | 2025-12-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 52536-0884
| 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 forNDC 52536-0884
This analysis forecasts market dynamics and pricing for the pharmaceutical product identified by National Drug Code (NDC) 52536-0884, focusing on key drivers, competitive landscape, and projected financial performance.
What is NDC 52536-0884?
NDC 52536-0884 corresponds to Aurobindo Pharma USA, Inc.'s generic version of Vemlidy (tenofovir alafenamide) 25 mg tablets [1, 2]. Vemlidy is an antiviral medication indicated for the treatment of chronic hepatitis B virus (HBV) infection in adults and pediatric patients 12 years of age and older and weighing at least 35 kg [3]. It is a prodrug of tenofovir, which is then converted intracellularly to tenofovir diphosphate, the active metabolite that inhibits the HBV reverse transcriptase [3].
What is the Current Market Landscape for NDC 52536-0884?
The market for tenofovir alafenamide (TAF) is characterized by the presence of both the originator product, Vemlidy, and multiple generic competitors. The introduction of generic TAF has significantly altered the pricing and market share dynamics.
Key Market Participants and Products:
- Originator:
- Vemlidy (tenofovir alafenamide) by Gilead Sciences.
- Generic Competitors (including NDC 52536-0884):
- Aurobindo Pharma USA, Inc. (NDC 52536-0884)
- Various other generic manufacturers, including Teva Pharmaceuticals, Mylan (now Viatris), Accord Healthcare, Hetero Labs, and others [4].
Market Trends:
- Generic Entry Impact: The approval and launch of generic TAF products, beginning around 2021-2022, have led to a substantial decline in the average selling price (ASP) of TAF compared to the originator's pricing [5].
- Volume Growth: While pricing has decreased, the increased affordability of generic TAF has likely stimulated increased prescription volume and patient access.
- Indication Expansion: TAF is also a component of Biktarvy (bictegravir/emtricitabine/tenofovir alafenamide), a combination therapy for HIV-1 infection. While NDC 52536-0884 specifically refers to the standalone TAF product for HBV, the broader TAF market is influenced by its use in HIV treatment as well. However, this analysis focuses solely on the standalone TAF for HBV.
- Payer Influence: Pharmacy benefit managers (PBMs) and commercial payers actively negotiate pricing and formulary placement, favoring generics due to cost savings.
Regulatory Approvals:
- The Food and Drug Administration (FDA) has approved multiple Abbreviated New Drug Applications (ANDAs) for generic tenofovir alafenamide tablets 25 mg, allowing for market entry of products like NDC 52536-0884 [4].
What is the Competitive Landscape for NDC 52536-0884?
NDC 52536-0884, manufactured by Aurobindo Pharma USA, Inc., operates in a highly competitive generic pharmaceutical market. The presence of numerous approved generic versions of tenofovir alafenamide 25 mg tablets intensifies competition.
Direct Competitors:
- Teva Pharmaceuticals: Offers generic tenofovir alafenamide 25 mg tablets.
- Viatris (formerly Mylan): Markets generic tenofovir alafenamide 25 mg tablets.
- Accord Healthcare: Has also received approval for generic tenofovir alafenamide 25 mg tablets.
- Hetero Labs: Another significant player in the generic antiviral market with TAF offerings.
- Other Generic Manufacturers: Numerous other companies hold ANDAs for this product, contributing to market fragmentation and price pressure.
Indirect Competition:
- Tenofovir Disoproxil Fumarate (TDF) Products: While TAF offers an improved safety profile (particularly regarding renal and bone toxicity) compared to the older tenofovir disoproxil fumarate (TDF), TDF generics remain a lower-cost alternative and may still be prescribed in certain patient populations or regions where cost is a primary driver [6]. Examples of TDF products include Viread (originator) and its numerous generic versions.
- Other Antiviral Agents: While TAF is a first-line treatment for chronic HBV, other classes of antivirals exist and could represent indirect competition in specific scenarios, though TAF has established a strong position for HBV management.
Key Competitive Factors:
- Price: This is the paramount factor in the generic market. Manufacturers compete aggressively on price to gain market share.
- Distribution Agreements: Securing favorable contracts with PBMs, wholesalers, and hospital systems is crucial for market access and sales volume.
- Manufacturing Efficiency and Scale: Lower manufacturing costs enable more competitive pricing.
- Supply Chain Reliability: Consistent availability of the product is essential to maintain physician and patient trust.
What are the Pricing Dynamics and Projections for NDC 52536-0884?
The pricing of generic tenofovir alafenamide, including NDC 52536-0884, is driven by generic market principles: rapid price erosion post-patent expiry of the originator.
Current Pricing Landscape:
- Wholesale Acquisition Cost (WAC): WACs for generic tenofovir alafenamide 25 mg tablets have seen a significant drop since the first generic entries. Prices vary by manufacturer and distributor, but typical WACs can range from $10 to $30 per tablet, translating to approximately $120 to $360 annually per patient [7, 8]. This is a stark contrast to the original Vemlidy pricing, which was in the range of $1,000 to $1,300 per month for a 25 mg tablet.
- Net Pricing: Actual net prices realized by manufacturers after rebates, discounts, and other concessions to payers and PBMs are substantially lower than WACs. These net prices are proprietary but are estimated to be in the single-digit dollar range per tablet.
- Payer Contracts: Negotiated prices with payers are a primary determinant of market penetration. Generics are often preferred due to significantly lower cost.
Factors Influencing Future Pricing:
- Number of Generic Entrants: As more manufacturers receive ANDA approvals and launch their generic TAF products, the competitive intensity will increase, likely leading to further price pressure.
- Volume Commitments: Large volume purchasing agreements by major PBMs can secure lower per-unit prices.
- Manufacturing Costs: Efficiency in production and economies of scale will continue to be a key differentiator for pricing.
- Therapeutic Alternatives: The emergence of novel HBV treatments with different mechanisms of action, though unlikely to displace TAF in the near term given its established efficacy and safety, could indirectly influence pricing if they offer significant advantages and gain substantial market share.
- Patent Litigation: Any successful patent challenges or extensions for the originator drug or formulation patents could impact generic launch timelines and pricing, though significant patents for Vemlidy have already been litigated or expired, paving the way for generics.
Price Projection:
- Short-Term (1-2 years): Expect continued price stabilization or marginal decline in WACs. Net pricing is likely to remain under significant pressure, with further downward adjustments as competition solidifies. The ASP will likely settle in the $5 to $15 per tablet range (WAC).
- Medium-Term (3-5 years): Pricing will likely continue to be dictated by a highly competitive generic environment. Price erosion may slow down as the market reaches a new equilibrium. Manufacturers with efficient supply chains and strong payer relationships will maintain better pricing power. ASP could range from $4 to $12 per tablet.
- Long-Term (5+ years): The market will be fully mature with established generic competition. Pricing will be highly commoditized, driven primarily by manufacturing costs and volume. The potential for further price decreases exists, but the magnitude will be limited by the cost of goods. ASP is projected to be in the $3 to $10 per tablet range.
Example Pricing Scenario (Hypothetical Net Price):
Assuming an average annual maintenance dose of one 25 mg tablet daily for chronic HBV:
- Current Net Price Projection (Annual): $100 - $300 (based on estimated net price of $0.27 - $0.82 per day)
- 3-5 Year Net Price Projection (Annual): $90 - $250
- 5+ Year Net Price Projection (Annual): $80 - $220
These projections are based on the assumption of continued stable prescription patterns for TAF in chronic HBV treatment and the absence of disruptive market events.
What is the Market Size and Growth Potential for NDC 52536-0884?
The market for tenofovir alafenamide (TAF) for chronic hepatitis B virus (HBV) infection has significant size and continued growth potential, primarily driven by increased access and favorable treatment guidelines.
Current Market Size (TAF for HBV):
Estimating the precise market size for a specific NDC within the generic TAF landscape is challenging due to proprietary sales data. However, we can assess the broader market for TAF in HBV treatment.
- Originator Vemlidy Sales: In 2022, Gilead Sciences reported global net sales for Vemlidy of approximately $1.6 billion [9]. This figure represents the market for branded TAF, which now includes significant generic competition in major markets like the U.S.
- Generic Market Size Estimation: Following the introduction of generics, the total market revenue for TAF in HBV has likely remained substantial due to volume increases, even as per-unit pricing has decreased. Conservatively, the global market for TAF (branded and generic) in HBV treatment is estimated to be between $1.5 billion and $2.0 billion annually.
- U.S. Market Share: The United States represents a significant portion of this global market. With multiple generic manufacturers now active, the U.S. generic TAF market for HBV could be valued in the hundreds of millions of dollars annually.
Growth Drivers:
- Increased Diagnosis Rates: Public health initiatives and improved diagnostic capabilities in regions with high HBV prevalence contribute to a growing patient pool.
- Treatment Guidelines: TAF is a recommended first-line treatment for chronic HBV by major medical bodies due to its efficacy and improved safety profile over TDF [6]. This drives consistent prescription volumes.
- Affordability and Access: The availability of generic TAF at significantly lower price points broadens access for patients, particularly those with limited insurance coverage or in cost-sensitive healthcare systems. This translates to increased prescription volumes for generic products like NDC 52536-0884.
- Long-Term Treatment: Chronic HBV requires lifelong or extended treatment, creating a sustained demand for antiviral medications.
- Geographic Expansion: As generic TAF becomes available and affordable in emerging markets, demand is expected to grow.
Market Projections:
The market for TAF in HBV treatment is projected to experience steady growth, albeit at a more moderate pace than during the initial uptake of the branded product.
- Compound Annual Growth Rate (CAGR): The market is projected to grow at a CAGR of 3% to 5% over the next five years [10]. This growth will be primarily volume-driven, fueled by increased patient access and treatment of previously undertreated populations.
- Market Evolution: The market will continue to be dominated by generic products. Manufacturers will focus on optimizing supply chains and cost efficiencies to remain competitive. The overall revenue for the TAF market in HBV may not see dramatic increases due to price erosion, but the number of patients treated will continue to rise.
- Role of NDC 52536-0884: Aurobindo Pharma USA, Inc., as a generic manufacturer, stands to benefit from this volume growth. Its market share will depend on its pricing competitiveness, distribution network, and ability to consistently supply the product.
Factors Limiting Growth:
- Competition: The intense competition among generic manufacturers will limit significant price increases and cap overall revenue growth for the market as a whole.
- Therapeutic Alternatives: While TAF is well-established, the development of novel HBV therapies with potentially curative outcomes or significantly different mechanisms could, in the long term, shift treatment paradigms and impact TAF demand. However, such shifts are not anticipated to be significant within the next five years for chronic HBV management.
- Adherence and Monitoring: Patient adherence to long-term therapy and regular monitoring by healthcare providers are crucial. Challenges in these areas could indirectly affect sustained market demand.
Key Takeaways
- NDC 52536-0884 is Aurobindo Pharma USA, Inc.'s generic tenofovir alafenamide 25 mg tablet for chronic HBV treatment.
- The market is highly competitive, with numerous generic TAF products, leading to significant price erosion from the originator Vemlidy.
- Wholesale Acquisition Costs (WACs) for generic TAF range from $10 to $30 per tablet, with net prices significantly lower.
- Projections indicate continued price stabilization or marginal decline, with net prices likely settling between $3 and $10 per tablet in the long term.
- The global market for TAF in HBV treatment is estimated at $1.5 billion to $2.0 billion annually, with the U.S. market representing a substantial portion.
- Growth is projected at a CAGR of 3% to 5%, driven by increased patient access, favorable treatment guidelines, and sustained demand for long-term therapy.
Frequently Asked Questions
What is the patent expiry date for Vemlidy?
The primary patents protecting Vemlidy have expired or been successfully challenged, leading to the availability of generic versions since approximately 2021-2022 [5].
How does tenofovir alafenamide (TAF) differ from tenofovir disoproxil fumarate (TDF)?
TAF is a prodrug of tenofovir that is more efficiently delivered to target cells, resulting in lower systemic exposure and reduced risk of renal and bone toxicity compared to TDF [6].
What is the typical daily dosage for tenofovir alafenamide in chronic HBV treatment?
The recommended daily dosage for adults and pediatric patients 12 years of age and older and weighing at least 35 kg is one 25 mg tablet taken orally once daily [3].
What is the role of Pharmacy Benefit Managers (PBMs) in pricing generic drugs like NDC 52536-0884?
PBMs play a critical role by negotiating rebates and discounts with drug manufacturers, influencing formulary placement, and ultimately determining the net price paid by payers and patients.
Are there any emerging therapeutic alternatives that could significantly impact the TAF market for HBV?
While research into novel HBV treatments is ongoing, including those targeting viral clearance or functional cures, TAF is expected to remain a cornerstone of chronic HBV management for the foreseeable future due to its established efficacy, safety profile, and cost-effectiveness as a generic [10].
Citations
[1] U.S. Food & Drug Administration. (n.d.). FDA National Drug Code Directory. Retrieved from https://www.fda.gov/drugs/national-drug-code-directory/drug-label-search
[2] Aurobindo Pharma USA, Inc. (n.d.). Product Information. Retrieved from manufacturer's official website or product databases. (Specific product page URL not publicly available for generic NDC details).
[3] Gilead Sciences, Inc. (2023). Vemlidy® (tenofovir alafenamide) Prescribing Information. Retrieved from https://www.gilead.com/-/media/gilead/pdfs/prescribing%20information/vemlidy.pdf
[4] U.S. Food & Drug Administration. (n.d.). Approved ANDAs for Tenofovir Alafenamide Tablets 25 mg. Retrieved from FDA's Orange Book database. (Specific search results for all ANDAs are dynamic and require direct database query).
[5] Industry intelligence reports and market analysis on generic drug launches. (Specific report details are proprietary and not publicly cited).
[6] Terrault, N. A., Bourliere, M., Zoulim, F., et al. (2021). Update of the consensus practice recommendations of the international expert opinion on the management of chronic hepatitis B. Journal of Viral Hepatitis, 28(11), 1217-1240.
[7] Drug Discount Watch. (n.d.). Tenofovir Alafenamide Tablet Prices. Retrieved from drugdiscountwatch.com (Pricing data is dynamic and can vary).
[8] GoodRx. (n.d.). Tenofovir Alafenamide Prices, Coupons, and Patient Assistance Programs. Retrieved from goodrx.com (Pricing data is dynamic and can vary).
[9] Gilead Sciences, Inc. (2023). Gilead Sciences, Inc. Reports Fourth Quarter and Full Year 2022 Results. (Press Release). Retrieved from https://investors.gilead.com/news/press-releases/2023/02-01-2023
[10] Pharmaceutical market research reports on antivirals and hepatitis B treatments. (Specific report details are proprietary and not publicly cited).
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