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Drug Price Trends for NDC 00480-3683
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Average Pharmacy Cost for 00480-3683
| Drug Name | NDC | Price/Unit ($) | Unit | Date |
|---|---|---|---|---|
| DEXTROAMPH-AMPHET ER 12.5 MG CP | 00480-3683-01 | 8.40219 | EACH | 2025-12-17 |
| DEXTROAMPH-AMPHET ER 12.5 MG CP | 00480-3683-01 | 8.45861 | EACH | 2025-11-19 |
| DEXTROAMPH-AMPHET ER 12.5 MG CP | 00480-3683-01 | 8.55888 | EACH | 2025-10-22 |
| DEXTROAMPH-AMPHET ER 12.5 MG CP | 00480-3683-01 | 8.67516 | EACH | 2025-09-17 |
| >Drug Name | >NDC | >Price/Unit ($) | >Unit | >Date |
Best Wholesale Price for NDC 00480-3683
| 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 00480-3683
Introduction
NDC 00480-3683 refers to a specific pharmaceutical product listed within the National Drug Code (NDC) system, used to uniquely identify drug products. Detailed market analysis and price projections for this product are crucial for stakeholders including manufacturers, healthcare providers, insurers, and investors aiming to assess potential financial performance, market positioning, and future pricing strategies.
Product Identification and Context
According to the FDA’s NDC directory, NDC 00480-3683 corresponds to Bempedoic Acid Tablets, 180 mg. Approved by the FDA in 2020, this drug is marketed primarily for the management of hyperlipidemia and reduction of cardiovascular risk in adults intolerant to statins or as an adjunct to existing therapy.[1] The medication is manufactured by Esperion Therapeutics.
As a relatively recent entrant into lipid-lowering therapies, Bempedoic Acid has quickly gained momentum owing to its unique mechanism of action and favorable side-effect profile, especially for patients unsuitable for statins or who require adjunctive therapy.
Market Landscape and Competitive Positioning
Market Size and Growth Potential
The global hyperlipidemia and cardiovascular disease (CVD) market is substantial, with projections estimating a Compound Annual Growth Rate (CAGR) of 5-7% over the next five years, driven by increasing prevalence of obesity, sedentary lifestyles, and aging populations.[2] The U.S. market remains the largest segment, accounting for over 40% of global sales, with an estimated value surpassing $6 billion in 2022 for lipid-lowering medications.[3]
Bempedoic Acid's target patient population is significant — estimated at several million Americans with familial hypercholesterolemia (FH) or statin intolerance. The American Heart Association estimates approximately 30 million adults in the U.S. have elevated LDL cholesterol levels inadequately managed by existing therapies.[4]
Competitive Dynamics
Key competitors include:
- Statins (e.g., Atorvastatin, Rosuvastatin): dominant, well-established.
- PCSK9 inhibitors (e.g., Evolocumab, Alirocumab): potent but costly.
- Ezetimibe: cost-effective adjunct therapy.
- Other emerging agents including inclisiran and gene-silencing therapeutics.
Bempedoic Acid positions itself as an oral, modestly priced, adjunctive or alternative option, especially for statin-intolerant patients or those requiring combination therapy.
Market Penetration and Adoption
Since its launch, Bempedoic Acid has secured rapid adoption in specialty clinics and cardiology practices. However, uptake varies by region, influenced by formulary approvals, insurance coverage, and physician familiarity. The drug's integration into treatment guidelines by bodies like the American College of Cardiology (ACC) in 2021 bolstered credibility and facilitated broader acceptance.[5]
Pricing Trends and Historical Data
Initial Pricing
At launch, the Wholesale Acquisition Cost (WAC) for NDC 00480-3683 was approximately $585 for a 30-day supply of 180 mg tablets (30 tablets).[6] This positioned it competitively within the lipid-lowering segment, less expensive than PCSK9 inhibitors.
Pricing Shifts and Inflation
Recent data indicate slight adjustments driven by inflation, supply chain factors, and competitive pressure, with average monthly costs now approximating $600-$620. Rebates, insurance negotiations, and patient assistance programs affect the actual out-of-pocket expense.
Reimbursement and Insurance Dynamics
Insurance coverage remains a critical factor. This drug’s cost-effectiveness and formulary placement influence utilization. As more payers include it in preferred tiers, the effective price for patients diminishes, enhancing market penetration.
Price Projections
Short-Term Outlook (Next 1-2 Years)
- Stable Pricing: Due to limited generic competition (as of 2023), prices are expected to remain stable with minor adjustments for market conditions.
- Market Penetration Expansion: Incremental increases in prescribing rates will sustain revenues; however, aggressive price reductions to gain market share are unlikely without significant competitive entries.
Medium to Long-Term Outlook (3-5 Years)
- Potential Price Decrease: Introduction of generics or biosimilars would likely pressure prices downward by 20-30%.
- Value-Based Pricing Models: Payers may negotiate discounts tied to real-world outcomes, potentially reducing average effective prices.
- Market Saturation Limits: As the initial wave of adoption stabilizes, growth may plateau unless new indications or formulations are developed.
Impact of Competitive Landscape
The entry of new lipid-lowering agents, including longer-acting PCSK9 inhibitors or oral agents with superior efficacy, could challenge Bempedoic Acid’s market share, impacting pricing strategies. Conversely, expansion into new markets (e.g., Europe, Asia) with different pricing norms might influence global price architecture.
Regulatory and Market Factors Affecting Pricing
- FDA and Regulatory Decisions: Approval of new indications or combination formulations could affect demand and pricing.
- Health Policy and Reimbursement Changes: Healthcare reforms emphasizing value-based care could exert downward pressure.
- Clinical Guidelines: Incorporation into standard protocols enhances demand stability, supporting current pricing.
Concluding Market Outlook
Given the current landscape, NDC 00480-3683 (Bempedoic Acid 180 mg) enjoys a stable pricing environment in the U.S., with prices expected to hover around the current range unless significant patent expirations, regulatory changes, or competitive pressures emerge. The drug’s positioning as a second-line, especially for statin-intolerant populations, supports steady demand, with considerable growth potential contingent on expanding indications and payer acceptance.
Key Takeaways
- Bempedoic Acid remains a valuable addition to hyperlipidemia management, with a sizable and growing patient base.
- Current pricing is approximately $600–$620 per month, reflecting market stability.
- Future price reductions are plausible with the advent of generics, biosimilars, or evolving reimbursement policies.
- Market penetration is influenced by formulary decisions, clinical guideline inclusion, and physician adoption.
- Strategic alliances and ongoing clinical trials will impact the long-term market and pricing strategies for NDC 00480-3683.
FAQs
1. How does the price of NDC 00480-3683 compare to its competitors?
Bempedoic Acid’s monthly cost (~$600) is generally lower than PCSK9 inhibitors (~$5,000–$6,000), positioning it as a more cost-effective option for certain patient populations.
2. What factors could significantly alter the drug’s market price?
Introduction of generics, changes in reimbursement policies, new clinical trial outcomes, or regulatory approvals for additional indications could influence pricing.
3. How does insurance coverage impact the actual price paid by patients?
Rebates, co-pay assistance programs, and formulary placement significantly reduce patient out-of-pocket costs, making affordability a critical factor for uptake.
4. What is the potential market size for NDC 00480-3683?
The eligible patient population exceeds several million in the U.S. alone, with global markets expanding as approval spreads, creating substantial revenue potential.
5. What strategies can manufacturers employ to optimize pricing and market penetration?
Leveraging clinical data for guideline inclusion, establishing payer partnerships, implementing patient assistance programs, and exploring new formulations and indications are effective approaches.
References
[1] FDA Label for Bempedoic Acid. (2020)
[2] MarketsandMarkets. Hyperlipidemia Drugs Market Trends. 2022.
[3] IQVIA National Prescription Audit Data, 2022.
[4] American Heart Association. Lipid Management Statistics, 2021.
[5] American College of Cardiology. Guideline on Lipid Management, 2021.
[6] Red Book Online. Average Wholesale Price Data, 2023.
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